Mitigation of Worker Exposure to Ethylene Oxide
The MITRE Corporation
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Mitigation of Worker Exposure to Ethylene Oxide
Renee Goldgraben
Neal Zank
March 1981
MTR-80W333
Sponsor: U.S. Environmental Protection Agency
Contract No.: 68-01-5944
The MITRE Corporation
Metrek Division
1820 Ootley Madison Boulevard
McLean, Virginia 22102
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80272-101
REPORT DOCUMENTATION
PAGE
1. REPORT NO.
-SPA 540/9-81-00]
3. Recipient*> Accession No.
4. Title and Subtitle
Mitigation of Worker Exposure to Ethylene Oxide
5. Report Date
March, 1981
7, Author(s)
Renee Goldgraben: Neal Zank
9. Performing Orgenlzation Name and Addresc
Mitre Corporation
Metrek Division
1820 Dolley Madison Boulevard
McLean, Virginia 22102
8. Performing Organization Rept. No
MTR-80 W333
10. Project/Task/Work Unit No.
11. Contract(C) or Grant(G) No.
(C) 68-01-5944
(G)
12. Sponsoring Organization Name and Address
U.S. Environmental Protection Agency
Washington, D.C. 20460
13. Type of Report & Period Covered
Research - 1980
14.
IS. Supplementary Notes
16. Abstract (Limit: 200 words)
Gaseous ethylene oxide (ETO) is widely used to sterilize and fumigate a wide
variety of goods which may be otherwise damaged by alternative treatment
techniques. Vforkers engaged in ETO sterilization/fumigation procedures may be
commonly exposed to ETO. Such exposure may be associated with adverse health
consequences.
This report describes the equipment and treatment procedures in use at selected
sites and identifies and categorizes situations leading to worker exposure to
ETO. Existing engineering, workplace design, and work practice measures to
control worker exposure are identified and categorized. The extent to which
these measures have beem implemented is also presented. In addition, this *
report briefly describes techniques and equipment available for ambient ETO
monitoring and identifies their advantages and limitations.
17. Document Analyaie a. Descriptors
b. Identifiers/Open-Ended Terms
c. COSATI Field/Group
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387
22. Price
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ABSTRACT
Gaseous ethylene oxide (ETO) is widely used to sterilize and
fumigate a wide variety of goods which may be otherwise damaged
by alternative treatment techniques. Workers engaged in ETO
sterilization/fumigation procedures may be commonly exposed to ETO.
Such exposure may be associated with adverse health consequences.
This report describes the equipment and treatment procedures
in use at selected sites and identifies and categorizes situations
leading to worker exposure to ETO. Existing engineering, workplace
design, and work practice measures to control worker exposure are
identified and categorized. The extent to which these measures have
been implemented is also presented. In addition, this report briefly
describes techniques and equipment available for ambient ETO monitor-
ing and identifies their advantages and limitations.
iii
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ACKNOWLEDGEMENT
The authors gratefully acknowledge the many industry represen-
tatives who graciously contributed to the information presented in
this document. Most notable are the following: Mr. Gary Ackert,
The 3M1 Corporation; Mr. James Spoden, American Sterilizer Company;
Mr. Thomas Weidrich, Castle-Sybron Corporation; Mr. Thomas F. Burns,
American Spice Trade Association; Dr. G. Briggs Phillips, Health
Industry Manufacturers Association; Mr. Glenn Runnells, formerly of
The American Hospital Association; and Dr. Thomas Samuels, Arizona
Health Sciences Center.
The authors wish to recognize the contributions of Ms. Arona
Butcher, Ms. Georgia Canellos, Mr. Myles Morse, Mr. Nathaniel Parker,
and Ms. L. Sue Russell, members of MITRE's technical staff, during the
the data collection phase of this study.
We also wish to thank Mr. Aram Beloian of the U.S. Environmental
Protection Agency for his suggestions and assistance.
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FOREWORD
The United States Environmental Protection Agency (EPA) regis-
ters all pesticide formulations used in the United States under
authority of the Federal Insecticide, Fungicide, and Rodenticide Act,
as amended (FIFRA) (7 U.S.C. 135 et seq.). Hie continued registra-
tion of any pesticide is questioned if the compound presents environ-
mental risks or exhibits characteristics which are potentially
harmful to human health. In such a case the EPA may issue a notice
of rebuttable presumption against registration (RPAR), which allows
for a period of information gathering and public comment before a
subsequent registration decision is made by the Administrator. A
notice of RPAR of ethylene oxide (ETO) was issued in the Federal Reg-
ister, Vol. 43, No. 19, on January 27, 1978 and was based upon the
scientific data cited in that notice.
The Administrator's registration decision ultimately will take
the form of unmodified continued registration, restricted registra-
tion, or cancellation of the EPA registrations of ETO. In arriving
at this decision in any given case, the Administrator must consider
the benefits obtained from present uses of ETO, the risks associated
with exposure, and the economic impacts associated with restriction
or cancellation of the pesticide registrations.
This report is intended to assist the Administrator by identi-
fying events and sources of potential worker exposure to ETO and the
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engineering, workplace design, and work practice measures available
to control such exposure. Included in this report are data depicting
the effectiveness of available control measures and assessments of
the extent to which such measures have been implemented at various
sites of use. Also included are descriptions of sampling techniques
and instruments available for measurement of ambient ETO concen-
trations .
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TABLE OF CONTENTS
Page
LIST OF TABLES xii
EXECUTIVE SUMMARY xv
1.0 INTRODUCTION 1-1
1.1 Scope 1-1
1.2 Approach 1-3
1.3 Limitations of Study 1_4
2.0 STERILIZATION/FUMIGATION EQUIPMENT AND PROCEDURES 2-1
2.1 Chambers 2-1
2.1.1 Vacuum Chambers 2-1
2.1.1.1 Equipment 2-3
2.1.1.2 Procedure 2-7
2.1.2 Atmospheric Chambers 2-8
2.2 Other Containment Equipment 2-10
2.2.1 Ampule/Liner Bag System 2-10
2.2.2 Single Item Sterilization System (Sterijet®) 2-11
2.2.3 Tarpaulin Fumigation 2-12
2.3 No Containment Equipment 2-15
2.4 Summary 2-16
3.0 ENVIRONMENTAL ETO MONITORING 3-1
3.1 Personnel Monitoring 3-1
3.2 Area Monitoring 3-4
3.3 Summary 3-9
4.0 WORKER EXPOSURE TO ETO 4-1
4.1 Common Exposure Sources and Events 4-2
4.1.1 Leaks from Gas Delivery Systems 4-7
4.1.2 Releases During Cycle Operation 4-7
4.1.2.1 Leaking Door Gaskets 4-7
4.1.2.2 Unvented Atmospheric Chambers 4-8
4.1.3 Releases During Exhaust Phase of Cycle 4-11
4.1.3.1 Discharge to Sewer Drain 4-11
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TABLE OF CONTENTS (CONTINUED)
Page
4.1.3.2 Vacuum Chamber Vented to the Workplace 4-13
4.1.3.3 Leaks to Chamber Vent Lines 4-14
4.1.4 Releases after Treatment Cycle 4-14
4.1.4.1 Unloading Chamber and Transferring 4-14
Treated Goods
4.1.4.2 Offgassing from Treated Goods in Storage 4-19
4.1.4.3 Releases from Aeration Cabinets 4-21
4.1.5 Cylinder Changeover Operations 4-23
4.2 Uncommon Exposure Sources 4-23
4.2.1 Failure of Door Locking Mechanism 4-23
4.2.2 Maintenance or Repair Work Resulting from System 4-24
Malfunction
4.2.3 Release of Emergency Relief Valve 4-24
4.2.4 Major ETO Leak or Spill 4-24
4.3 Summary 4-25
5.0 AVAILABLE CONTROL MEASURES' TO MITIGATE WORKER EXPOSURE 5-1
TO ETO
5.1 Engineering Modifications to Sterilization/Fumigation 5-1
Equipment
5.1.1 Automatic Leak Detection Systems 5-2
5.1.2 Chamber Evacuation System Modifications 5-5
5.1.2.1 Multiple Post-Vacuums 5-7
5.1.2.2 Pulsating Post-Vacuum 5-8
5.1.2.3 Air Wash 5-12
5.1.3 Liquid/Gas Separator 5-17
5.1.4 Remote-Control Door Opening 5-19
5.1.5 Chamber Ventilation Systems 5-20
5.1.5.1 Differential Pressure Chamber Venti- 5-20
lation Systems
5.1.5.2 Local Exhaust Hoods 5-22
5.1.6 Other Engineering Modifications 5-29
5.1.6.1 Check Valves Installed in ETO Supply 5-29
Line
5.1.6.2 Venting Chamber Pressure Relief Valve 5-29
5.1.6.3 Aeration Cabinet Venting 5-29
5.2 Workplace Design Modifications 5-30
viii
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TABLE OF CONTENTS (CONTINUED)
Page
5.2.1 Ventilation 5-30
5.2.1.1 General Area Ventilation 5-30
5.2.1.2 Local Exhaust Ventilation 5-32
5.2.2 Isolation 5-34
5.2.2.1 Partitions 5-34
5.2.2.2 Location of Equipment and Work Station 5-35
5.3 Work Practices 5-35
5.3.1 Operator Training 5-36
5.3.2 Equipment Operation Procedures 5-36
5.3.3 Material Handling Procedures 5-37
5.3.4 Equipment Maintenance 5-38
5.3.5 Personal Protective Equipment 5-38
5.4 Summary 5-39
6.0 IMPLEMENTATION OF MEASURES TO CONTROL AND MONITOR 6-1
WORKER EXPOSURE TO ETO AND POTENTIAL EXPOSURE
SITUATIONS AT SELECTED SITES
6.1 Health Care and Health Diagnosis and Treatment 6-4
Facilities
6.1.1 Use of ETO in Health Care Facilities 6-4
6.1.2 Situations Associated with Potential Worker^ 6-4
Exposure
6.1.3 Control Measures 6-5
6.1.4 Monitoring 6-7
6.2 Medical Products Industry 6-8
6.2.1 Use of ETO By the Medical Products Industry 6-8
6.2.2 Situations Associated with Potential Worker 6-8
Exposure
6.2.3 Control Measures 6-9
6.2.4 Monitoring 6-11
6.3 Libraries 6-12
6.3.1 Use of ETO in Libraries 6-12
6.3.2 Situations Associated with Potential Worker 6-13
Exposure
6.3.3 Control Measures 6-14
6.3.4 Monitoring 6-14
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TABLE OF CONTENTS (CONTINUED)
Page
6.4 Museums 6-15
6.4.1 Use of ETO in Museums 6-15
6.4.2 Situations Associated with Potential Worker 6-16
Exposure
6.4.3 Control Measures 6-17
6.4.4 Monitoring 6-18
6.5 Research Laboratories 6-18
6.5.1 Use of ETO in Research Laboratories 6-18
6.5.2 Situations Associated with Potential Worker 6-19
Exposure
6.5.3 Control Measures 6-20
6.5.4 Monitoring 6-21
6.6. Transportation Sites 6-22
6.7 Beekeeping Industry 6-23
6.7.1 Use of ETO in the Beekeeping Industry 6-23
6.7.2 Situations Associated with Potential Worker 6-24
Exposure
6.7.3 Control Measures 6-24
6.7.4 Monitoring 6-25
6.8 High Containment Research Laboratories in Agriculture 6-25
6.8.1 Use of ETO by High Containment Research 6-25
Laboratories
6.8.2 Situations Associated with Potential Worker 6-26
Exposure
6.8.3 Control Measures 6-26
6.8.4 Monitoring 6-27
6.9 Animal and Plant Service Quarantine at Ports of Entry 6-27
6.9.1 Use of ETO at Ports of Entry 6-27
6.9.2 Control Measures 6-28
6.9.3 Monitoring 6-29
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TABLE OF CONTENTS (CONCLUDED)
Page
6.10 Spices, Seasonings, and Black Walnut Meats Industry 6-29
6.10.1 Use of ETO By the Spice Industry 6-29
6.10.2 Situations Associated with Potential Worker 6-30
Exposure
6.10.3 Control Measures 6-30
6.10.4 Monitoring 6-32
6.11 Cosmetics Industries 6-33
6.11.1 Use of ETO By the Cosmetics Industry 6-33
6.11.2 Situations Associated with Potential Worker 6-34
Exposure
6.11.3 Control Measures 6-34
6.11.4 Monitoring 6-35
6.12 Dairy Packaging Industry 6-35
7.0 CONCLUSIONS 7-1
8.0 REFERENCES 8-1
APPENDIX A - SITE VISITS CONDUCTED A-l
APPENDIX B - EVALUATION OF WORKER EXPOSURE AND AMBIENT ETO B-l
CONCENTRATIONS AT A HOSPITAL CENTRAL SUPPLY
FACILITY
APPENDIX C - PRACTICES RELATIVE TO WORKER EXPOSURE AT C-l
SELECTED SITES
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LIST OF TABLES
Z5ge
Table Number
2-1 TYPES OF ETO STERILIZATION/FUMIGATION 2-2
EQUIPMENT USED AT DIFFERENT SITES
2-2 SUMMARY OF ETO STERILIZATION/FUMIGATION 2-17
EQUIPMENT
3-1 SUMMARY OF ETO PERSONAL MONITORING TECHNIQUES 3-3
3-2 SELECTED ETO AMBIENT MONITORING 3-6
INSTRUMENTATION
4-1 ETO WORKER EXPOSURE AT SELECTED CALIFORNIA 4-3
HOSPITALS
4-2 ETO RELEASED TO WORKPLACE DURING OPERATION 4-9
OF A BEN VENUE STERILIZER
4-3 ETO RELEASED TO WORKPLACE DURING OPERATION 4-10
OF ANPROLENE AN-70, AN-72, AND AN-74
STERILIZERS
4-4 ETO RELEASED TO WORKPLACE DURING OPERATION 4-12
OF CASTLE-SYBRON 1500 ATMOSPHERIC STERILIZER
4-5 ETO CONCENTRATIONS RECORDED 1 FOOT AWAY FROM 4-16
STERILIZER AFTER CHAMBER DOOR OPENED
4-6 ETO CONCENTRATIONS RELEASED TO THE WORKPLACE 4-18
ASSOCIATED WITH DELAY IN DOOR OPENING
4-7 WORKER EXPOSURE TO ETO WHILE UNLOADING 4-20
CHAMBER AND TRANSFERRING GOODS TO AERATOR
4-8 ETO CONCENTRATIONS MEASURED AT AERATION 4-22
CABINET EXHAUST VENT
4-9 SUMMARY OF SOURCES AND EVENTS ASSOCIATED WITH 4-26
POTENTIAL WORKER EXPOSURE TO ETO
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LIST OF TABLES (CONTINUED)
I*g&
Table Number
5-1 SUMMARY OF CURRENTLY AVAILABLE ENGINEERING 5-3
CONTROL MEASURES
5-2 SUMMARY OF AVAILABLE MODIFICATIONS TO 5-6
CHAMBER EVACUATION SYSTEMS
5-3 ETO CONCENTRATIONS IN CLOSED CHAMBER 5-9
AFTER SUCCESSIVE POST-VACUUMS
5-4 EFFECTIVENESS OF PULSATING POST-VACUUM IN 5-11
REDUCING EXPOSURE TO ETO
5-5 EFFECTIVENESS OF CONTINUOUS PURGE EVACUATION 5-16
SYSTEM IN REDUCING WORKER EXPOSURE TO ETO
5-6 EFFECTIVENESS OF A LOCAL EXHAUST HOOD IN 5-25
REDUCING WORKER EXPOSURE TO ETO
5-7 SUMMARY OF AVAILABLE CONTROL MEASURES TO 5-40
MITIGATE WORKER EXPOSURE TO ETO
6-1 SUMMARY OF EXTENT OF IMPLEMENTATION OF 6-2
MEASURES TO CONTROL AND MONITOR WORKER
EXPOSURE TO ETO AT SELECTED SITES
(BY NUMBER)
C-l PRACTICES RELATIVE TO WORKER EXPOSURE AT C-2
HEALTH CARE FACILITIES
C-2 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-70
SELECTED MEDICAL PRODUCTS INDUSTRY SITES
C-3 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-l05
SELECTED LIBRARY SITES
C-4 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-l18
SELECTED MUSEUM SITES
C-5 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-126
SELECTED RESEARCH LABORATORIES
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LIST OF TABLES (CONCLUDED)
Page
Table Number
C-6 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-133
SELECTED TRANSPORTATION SITES
C-7 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-134
SELECTED BEEKEEPING SITES
C-8 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-144
SELECTED HIGH CONTAINMENT RESEARCH
LABORATORIES IN AGRICULTURE
C-9 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-148
SELECTED PORTS OF ENTRY
C-10 PRACTICES RELATIVE TO WORKER EXPOSURE AT C-153
SPICE INDUSTRY SITES
C-ll PRACTICES RELATIVE TO WORKER EXPOSURE AT C-176
COSMETICS INDUSTRY SITES
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EXECUTIVE SUMMARY
The objective of this study is to identify and categorize engi-
neering, workplace design, and work practice measures available to
control worker exposure to ethylene oxide (ETO) in facilities where
it is used as a sterilant/fumigant. Specifically, the equipment and
procedures in use for ETO application at 12 sites are identified.
Existing measures to control worker exposure to ETO are also identi-
fied. In addition, techniques and equipment available for monitoring
ambient ETO concentrations are described.
ETO treatment is most commonly conducted in a vacuum chamber (a
hermetically sealed, high pressure vessel equipped with a vacuum sys-
tem) . The vacuum system is used to evacuate air from the chamber
prior to introduction of the sterilant and to remove a portion of the
ETO/air mixture from the chamber at the conclusion of the treatment
cycle* The exhausted mixture is typically vented to the outside
atmosphere or, after being mixed with water, to a sewer drain. Vac-
uum chambers range in size from less than 4 cubic feet to 3000 cubic
feet and are the most common type of equipment used at 10 of the 12
selected sites.
Monitoring equipment used to measure ambient ETO concentrations
can be divided into two basic categories: personnel monitoring and
area monitoring. Personnel monitoring equipment is used to determine
actual.levels of worker exposure and to verify compliance with appli-
cable standards by providing an integrated exposure value (time
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weighted average). While readily portable, extremely sensitive, and
specific to' ETO, personnel monitoring techniques require laboratory
analysis. The resulting data do not indicate the specific source or
event associated with exposure and may mask short term exposure to
high ETO concentrations.
Direct reading instruments, which provide immediate, quantita-
tive indication of ambient ETO levels, are used for area monitoring.
Such instruments are suitable for determining peak concentrations,
and changes in concentrations over time and at different locations
within the work area; however, their primary limitations are related
to specificity and portability.
The most commonly used type of direct reading instrument is a
portable infrared gas analyzer. Depending upon the wavelength used,
Freon®, carbon dioxide, or water vapor may act as interfering sub-
stances. In addition, such instruments have been reported to have
limited accuracy at low concentrations (less than 10 ppm) (Opp 1980).
Other types of direct reading instruments employ combustion, thermal
conductivity, flame ionization, photoionization, and colorimetric
detection mechanisms.
Employees involved in the treatment process as well as others in
the general vicinity may be exposed to gaseous ETO which is released
to the workplace. Common sources of release prior to and during
the cycle include leaks from gas delivery systems, leaks from door
gaskets, and releases from chambers not designed to effect a hermetic
xvi
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seal. In addition, ETO may be released to the workplace during the
exhaust phase of the vacuum cycle from spillage at the drain vent
connection, leaks from the chamber vent system, and, in some
instances, from chambers which are vented directly into the work-
place.
The greatest opportunity for worker exposure occurs after com-
pletion of the cycle, when the chamber is opened and the treated
goods are removed and transferred to an aerator or aeration area.
When the door is opened, unevacuated gases remaining in the chamber
rapidly escape and disperse throughout the workplace. In addition,
workers may be exposed to ETO which offgasses from the treated goods
during transfer and in storage as well as from aeration cabinets
which are vented directly into the workplace. Finally, workers who
are engaged in replacing emptied sterilant cylinders may be actively
exposed to ETO which remains in the cylinder and in transport lines.
In addition to these common sources of release, other less fre-
quent occurrences may result in worker exposure, including: failure
of door locking mechanism, maintenance or repair work resulting from
equipment breakdown or system malfunction, release of chamber pres-
sure relief valve, and major ETO leaks from the tank, tank valves, or
ruptured gas lines.
Available data indicate the average worker exposure levels com-
ply with current standards (50 ppm as an 8 hour time weighted average
exposure); however, many workers may be exposed to high ETO concen-
trations for short time periods.
xvii
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Available control measures to mitigate worker exposure include
engineering modifications to the sterilization/fumigation equipment
as well as workplace design and work practice considerations. In
general, engineering modifications address specific exposure sources
by preventing or minimizing the release of ETO to the workplace.
These encompass control systems to monitor leaks to the chamber,
improvements in the effectiveness of the evacuation system, and
internal or external ventilation systems, among others.
Leak detection and control systems are incorporated as standard
features in some new chamber designs (AMSCO Eagle Series and 3M 400B
and 202B models, among others) and are intended to notify the chamber
operator or abort the cycle in the event of a leak. Such measures
are, however, not available for retrofitting onto existing
installations.
A number of improvements to the chamber evacuation system are
currently available. Successive multiple post-vacuums are offered
by AMSCO, Vernitron, and Beverly Pacific; pulsating post-vacuum
modifications are offered by Castle-Sybron, and continuous purge
evacuation systems are offered by 3M. The pulsating post-vacuum is
associated with a 52 percent reduction in average ambient ETO concen-
trations during the first 5 minutes after door opening and an 86 per-
cent reduction in operator exposure (Samuels and Corn 1979b). The
continuous purge feature, which allows air to pass through the cham-
ber until the door is opened, is associated with peak ETO release of
xviii
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approximately 6 ppm (Samuels and Corn 1980), a significant reduction
from typical levels Which may range from 100 to 1000 ppm (Ackert
1980).
Control features are also available to separate and divert ETO
which may be released at the drain vent (liquid/gas separator) and
to capture and remove ETO which escapes from the chamber after the
sterilizer door is opened. External ventilation systems (exhaust
hoods) are commercially available for some small units (3M, Castle—
Sybron, H.W. Andersen). Use of such a hood was found to reduce peak
ETO concentration from approximately 600 to 1200 ppm to approximately
60 to 70 ppm and to reduce operator exposure levels by approximately
52 to 63 percent (Samuels and Corn 1979a).
Internal ventilation systems incorporated into large industrial
chambers are designed to create an airflow from the workplace through
the chamber, to assure that little or no ETO is released to the
workplace. Such systems may be implemented by modifying the chamber
recirculation system, by operating the vacuum pump after the chamber
door is opened, or by installing a separate exhaust system into the
chamber roof.
Workplace design considerations include the provision of ade-
quate ventilation, whether general area or local exhaust, and iso-
lation of exposure sources by physical barriers or distance. General
area ventilation primarily serves to dilute any ETO which is released
to the workplace and thereby to control passive exposure. Local
xix
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exhaust ventilation systems capture and remove ETO from a number of
potential release sources by the appropriate location of vent ducts.
Similarly, passive exposure can also be controlled by construction
of partitions around the chamber machinery area, by centralizing and
restricting access to sterilization facilities, and by traffic con-
trol within these areas.
Work practices also may be instituted. Specific operating
procedures, reinforced by training, may serve to reduce unnecessary
worker exposure. On occasion, use of protective clothing and respi-
ratory equipment may be appropriate. Finally, preventive maintenance
programs may control the release of ETO from leaks and other system
malfunctions.
Many ETO-user facilities have incorporated some equipment,
workplace design, and work practice features which serve to control
unnecessary worker exposure. In many cases, these were included in
the initial chamber installation rather than incorporated at some
later date for the specific purpose of reducing worker exposure. In
general, health care and industrial ETO users have been most likely
to implement control measures, often in response to monitoring pro-
grams which identified specific high exposure events. ETO users at
other sites have generally made little effort to assess and control
worker exposure.
Based on available information, it was concluded that ETO expo-
sure levels could be reduced substantially below current standards
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by the implementation of available control measures. Some industrial
ETO users have lowered average worker exposure levels to 5 ppm as an
8 hour time weighted average. Other ETO users have implemented con-
trols sufficient to comply with current standards but are delaying
implementation of additional measures until the anticipated standard
revisions are published in order to be assured that they will be in
compliance.
xxi
-------
1.0 INTRODUCTION
Gaseous ethylene oxide (GTO) is widely used as a sterllant for
the treatment of a wide variety of heat and moisture sensitive items
that would be otherwise damaged by steam sterilization. It is used
to sterilize reusable items at hospitals and other health care and
health diagnosis facilities and by industrial manufacturers to pro-
cess packaged, presterilized, disposable medical items. Because it
is effective at ambient temperature and humidity, it is also used to
decontaminate a wide variety of non-medical items, including spices
and food packaging, books, archival materials, museum artifacts, lab-
oratory apparatus, and beehives, among others.
Workers engaged in the ETO treatment processes, as well as other
workers present in the general vicinity, may be routinely exposed
to ETO. Such continuous occupational exposure is considered to be
a potential health hazard to these workers. The National Institute
for Occupational Safety and Health (NIOSH) recommends that ETO be
considered mutagenic and potentially carcinogenic to humans and that
occupational exposure be minimized through the implementation of var-
ious control measures, such as improved equipment design, workplace
design, and work practices (Glaser 1977).
1.1 Scope
This report identifies the control measures which are currently
available to users of ETO and assesses the extent to which these
1-1
-------
measures have been Implemented at various sites of use. The sites of
use considered are:
• Health care and health diagnosis and treatment facilities
• Medical products industry
• Libraries
• Museums
• Research laboratories
• Transportation sites
• Beekeeping Industry
• High containment agricultural research laboratories
• Animal and plant health service quarantine at ports of entry
• Spices, seasonings, and black walnut meats industry
• Cosmetics industry
• Dairy packaging industry.
Specifically, the types of sterilization/fumigation equipment
and procedures used at each of the above sites are identified and
categorized. Situations resulting in potential worker exposure are
identified and categorized according to the causal factors, the
likelihood of occurence, and the extent of ETO release.
Sampling techniques and instruments capable of measuring ambient
ETO are identified and assessed in terms of range, specificity,
intended use and ease of operation.
In addition, engineering, workplace design, and work practice
modifications available to minimize worker exposure are Identified.
1-2
-------
These control measures are compared with the situations resulting
in ETO release/exposure to assess possible gaps or alternative
approaches in mitigating worker exposure. Available data regarding
the extent of exposure reduction associated with specific control
measures are presented.
For each site of use, information is presented for individual
facilities that summarizes the equipment in use, the nature of actual
or potential exposure situations, and the types of control measures
which have been implemented to mitigate worker exposure.
1.2 Approach
This report utilizes information derived from the existing
literature, unpublished reports, and personal communications.
An extensive computerized data search was conducted to identify
relevant literature related to use and worker exposure to ethylene
oxide in industries where it is used as a sterilant/fumigant.
Articles related to exposure levels, routes of exposure, instances of
exposure, and methods of mitigating worker exposure were searched.
The following data bases were accessed:
• Medline and backfiles - 1966 to present
• Health Planning and Administration - 1975 to present
• Toxline and Toxback*
*Toxline and Toxback contain a variety of files, most of which
begin between 1965 and 1970.
1-3
-------
In addition to direct contact of ETO users, trade associations whose
members use ETO for sterilization or fumigation were contacted and
their cooperation elicited in gathering information from their mem-
bers regarding the types and effectiveness of control measures that
have been implemented at individual facilities. These trade asso-
ciations and the number of member companies from which information
was requested are:
• American Hospital Association - 200 hospital central supply
departments
• Health Industry Manufacturers Association - 130 member
companies
• American Spice Trade Association - 27 member companies
Finally, site visits were also made in the course of this study
(see Appendix A).
1.3 Limitations of Study
As published information regarding the nature and extent of
worker exposure to ETO and available measures to control such expo-
sure is limited, primary sources were relied upon. Many of these
sources, primarily industrial users of ETO, however, were reluctant
to provide monitoring data as such information was generally con-
sidered to be proprietary.
Much of the collected information regarding worker exposure
to ETO pertains to the use of ETO at hospital facilities. Such in-
formation may not be directly applicable to other user sites due to
1-4
-------
differences in equipment, procedures, and the nature of the goods
being processed.
Information on the available control measures for mitigating
worker exposure to ETO was obtained primarily from manufacturers of
sterilization/fumigation equipment. As such, the information may not
be exhaustive as ongoing modifications and control technologies being
developed by individual facilities may not have been identified.
Data regarding the effectiveness of these modifications are extremely
scarce. Most of the efforts to assess the effectiveness of control
measures have been limited to specific engineering controls; little
evaluation has been conducted of workplace design or work practice
measures and no information was identified to assess the marginal
reduction in worker exposure associated with a combination of control
measures. Consequently, it was not possible to provide estimates of
the extent of reduction in worker exposure associated with many work-
place or work practice control measures. In addition, the available
data may not be representative of the effective reduction of exposure
at facilities other than those where the evaluation was conducted;
differences in the equipment, goods treated, workplace design, and
operating practices employed at user sites limit such generalization.
Assessment of the extent to which control measures have been
implemented is based on a limited sample of the total user population
at each site of interest. The information at three sites (hospitals,
medical products industry, and spice trade industry) was collected by
1-5
-------
their respective trade associations. Because of the decision of
these associations not to identify the facilities providing the
information, it was not possible to verify or supplement any of the
reported information. In addition, it was not possible to identify
health diagnosis facilities (doctors, dentists, and veterinarians in
private or clinical practices) who may be using ETO sterilization
equipment. Medical, dental, and veterinary professional associations
who were contacted in the course of this study were unable to provide
any information regarding ETO use among their members.
1-6
-------
2.0 STERILIZATION/FUMIGATION EQUIPMENT AND PROCEDURES
Sterilization/fumigation with ETO is accomplished by exposing
the contaminated materials to gaseous ETO for an extended period
of time. The treatment process is conducted in a closed system to
facilitate maintenance of the required gas concentration over the
exposure period.
Various types of containment equipment are used for ETO
sterilization/fumigation. The types of equipment may be categorized
as follows:
• Chambers
- vacuum
- atmospheric
• Other containment equipment
- ampule/liner bag
- single item sterilizer (Sterijet®)
- tarpaulin
In some instances no separate containment equipment is used. Rather,
the item being treated Itself serves as the enclosure* Table 2-1
summarizes the types of equipment used at the selected sites. The
equipment and associated procedures are discussed below and presented
in more detail in Section 6.0.
2.1 Chambers
2.1.1 Vacuum Chambers
Vacuum chambers are the most commonly used type of ETO
sterilization/fumigation equipment. These chambers are basically
2-1
-------
TABLE 2-1
TYPES OF ETO STERILIZATION/FUMIGATION
EQUIPMENT USED AT DIFFERENT SITES
u
8
J
g
I
I
4J
•
1
*>
u
1
N. Equipment
1
"3
*
1
•
•3
n
M
•
J?
v
0
0}
!
1
2
J
Sites of Use
j
B
<
i
i
w
£
Health Care and Health Diagnosis
V
y/
V
and Treatment Facilities
Medical Products Industry
V
V
Libraries
V
Museums
V
V
Research Laboratories
V
Tranaportatlon Sites
V
Beekeeping Industry
V
V
High Coat aim eat Research
V
Laboratories In Agriculture
Animal and Plant 8ervlce
Quarantine at Ports of Entry
Spices, Seasoning* and Black Walnut
V
Meats Industry
Cosmetics Industry
Dairy Packaging Industry
V
2-2
-------
pressure vessels equipped with a vacuum system which operates inter-
mittently during the treatment process. The vacuum pump is used to
remove air from the chamber at the beginning of the treatment process
in order to facilitate diffusion of ETO into the contaminated mate-
rial and again after the exposure period to remove some of the ETO/
air mixture present in the chamber. Typically, the evacuated ETO is
vented either to the outside atmosphere or to the sewer.
2.1.1.1 Equipment. Vacuum chambers may be categorized by size
into small (less than 4 cubic feet), intermediate (greater than 4
cubic feet and less than 100 cubic feet) and large (greater than 100
cubic feet) chambers.
Small chambers are primarily countertop models and are most
commonly used in health care and health diagnosis facilities. In
hospitals, they are primarily located in decentralized sterilization
facilities such as inhalation therapy centers and operating rooms
(Ackert 1980; Mack 1980). Such chambers are also used to a limited
extent in research and industrial facilities.*
Manufacturers of such chambers identified in the course of this
study include Advanced Instruments, Amdek, American Cystoscope Maker
(ACMI), The 3M Company (3M), American Sterilizer Company (AMSC0),
and Vernitron. Only the last three companies continue to market such
chambers.
*Examples of industrial users of small chambers include manufac-
turers of contact and interoccular lenses (Ackert 1980).
-------
Small vacuum chambers utilize either unit dose cartridges con-
taining a premeasured amount of 100 percent ETO (Advanced Instru-
ments, Amdek, ACMI and 3M) or a gas mixture of 12 percent ET0/88
percent Freon® in pressurized cylinders (AMSCO, Vernitron). Cham-
bers designed to utilize unit dose cartridges are equipped with a
receptacle into which the cartridge is placed. The sterilant is
released by puncturing the cartridge either manually, by screwing
down a cap over the receptacle, or automatically, as in the newer
3M models. AMSCO and Vernitron chambers incorporate an external
gas delivery system. The cylinders are connected to the sterilizer
by means of valves, fittings, and piping.
Small chambers are generally vented directly to the outside
atmosphere via a length of copper or plastic tubing. Some earlier
models, primarily those intended to be portable, were vented either
directly into the workplace or into a sponge kept damp in a bucket
of water.*
Intermediate-sized chambers are used primarily in hospital
central supply facilities. Other use sites include research and
industrial facilities, libraries, museums, and beehive fumigation
facilities. Manufacturers of such chambers include AMSCO, Castle-
Sybron, Miskoe, Vacudyne-Altair and Vernitron. AMSCO, Castle-Sybron,
*Venting into a damp sponge had been, at one time, recommended as
an alternative to a fixed vent line to the atmosphere by Advanced
Instruments, Amdek, and ACMI (Emergency Care Research Institute
(ECRI) 1975). No information was available to estimate the number
of small vacuum chambers which may still be vented in this manner.
2-4
-------
and Vernitron primarily market to hospital users, although they also
sell their chambers to research and industrial facilities. Vacudyne-
Altair and Miskoe manufacture fumigators; the former markets to
libraries, archives, and museums and the chambers manufactured by
Miskoe are used exclusively for beehive fumigation.
Intermediate-sized chambers are available in various configura-
tions. Vacudyne-Altair and Miskoe units are typically freestanding
while AMSCO, Castle-Sybron, and Vernitron chambers may be freestand-
ing or, as in many hospital installations, built-in. The latter are
available in single or double door designs* Double door chambers are
used in some hospital central supply departments and high containment
research laboratories to permit loading the unsterilized goods from
a contaminated area and unloading them, after processing, into a
"clean" area.
All the intermediate-sized chambers Identified in the course of
this study utilize gas mixtures in pressurized cylinders. Some of
the newer models manufactured by AMSCO* Caetle-Sybron, and Vernitron
are designed to permit several cylinders to be connected to the
sterilizer, thereby minimizing the possibility that a cycle will be
aborted due to insufficient sterilant supply.
These chambers are vented either directly to the outside atmo-
sphere (Vacudyne-Altair, Miskoe)* or to a sewer drain (AMSCO,
*Miskoe chambers are frequently located outdoors. .1. Some of these
chambers are equipped with a long vent line to direct the exhausted
gases to an area some distance from the chamber (see Section 6.7).
-------
Castle-Sybron, Vernitron). In the latter installations, the ex-,
hausted gases are directed through the water ring seal component of
the vacuum pump where they are mixed with the water. The liquid/gas
mixture is then directed to a floor drain typically located near the
rear of the chamber.*
Large chambers may range from 100 cubic feet upwards to 3000
cubic feet and are used primarily for the industrial sterilization
of medical products, spices and other commodities. These chambers
are custom manufactured by AMSCO, Vacudyne-Altair, Environmental Tec-
tonics, Beverly Pacific, and Vernitron to meet the specifications of
the user.
Approximately 1000 such chambers are estimated to be in use
(Nusbaum 1980b). Of these, approximately 250 to 275 have been manu-
factured by Vacudyne-Altair (Markinson 1980a), 100 by Environmental
Tectonics (D'Aquila 1980), 60 to 70 by Beverly Pacific (Slas 1980),
and 300 to 350 by AMSCO (Spoden 1980).
ft ft
Industrial chambers may utilize 100 percent ET0 or a gas mix-
ture. Some chambers are designed to permit use of either sterilant
formulation. Sterilant formulations are supplied in pressurized
cylinders or, in some cases, in large tanks (Skocypec 1980). Most
*Local plumbing codes frequently preclude a solid connection
between the vent line and the sewer drain in order to prevent
the possible back-up of sewer gases.
JL JL
Cycles which utilize 100 percent ET0 operate under negative
pressure throughout the exposure phase.
2-6
-------
typically, exhausted gases from large industrial chambers are vented,
after being mixed with water, to a sewer drain.
2.1.1.2 Procedure. While vacuum chambers vary widely in size
and design features, they entail essentially the same operating se-
quence as follows:
• Contaminated material is loaded into the chamber.
• The chamber door is closed to effect a hermetic seal
• A vacuum is created in the chamber (pre-vacuum) to remove
air which acts as a barrier to the diffusion of heat, mois-
ture, and ETO into the load.
• ETO is vaporized and introduced into the chamber to a pre-
determined pressure or concentration. The sterilant may be
either 100 percent ETO or a nonflammable mixture of either
12 percent ETO/88 percent Freon® or, less commonly, 10 per-
cent ETO/90 percent carbon dioxide.
• The load is exposed to gaseous ETO for a predetermined
period. When 100 percent ETO is used, a sub-atmospheric
pressure is maintained throughout the exposure phase (Ackert
1980; Markinson 1980b). Cycles using gas mixtures operate
under positive pressure during the gas exposure phase.
• A vacuum is created in the chamber to remove ETO (post-vfccuum
or exhaust vacuum). The ETO/gas mixture is vented from the
chamber and directed, via a vent line, to the outside atmo-^
sphere or to a sewer drain.
• Filtered air is introduced into the chamber until atmospheric
pressure is reached.
• The chamber is opened and the treated materials are removed.
They .®t this point, be transferred to an aeration
cabinet or placed in a stofaige area.
*Aeration cabinets circulate air at elevated temperature around the
treated goods to facilitate offgassing of residual ETO which may be
absorbed or entrapped in these goods. Aeration cabinets are used
almost exclusively in hospital sterilization facilities. Aeration
cabinet venting is discussed in Section 5.1.6.3.
2-7
-------
The procedures followed in unloading the chamber and handling
the treated goods vary both with the chamber size and the type of
facility. In general, small vacuum chambers are unloaded manually
(i.e. one item at a time). Some of these chambers are equipped
with metal baskets to minimize the necessity for direct handling
of treated goods and to minimize the time required to unload the
chamber and transfer its contents. Many intermediate-sized chambers,
particularly those used in hospital central supply departments, uti-
lize multi-tiered carts which are designed to fit into the chamber
and then to be transferred directly to a compatibly sized aeration
cabinet.
Large industrial chambers often require the operator to enter
the chamber to remove the treated goods. In some facilities, cham-
bers are equipped with a roller mechanism which permits pallets to
be brought to the front of the chamber and eliminates the need for
the operator to enter the chamber (see Sections 6.2 and 6.10). Typi-
cally, these goods are transported by hand trucks or fork lift trucks
to a storage area.
2.1.2 Atmospheric Chambers
Atmospheric chambers do not utilize a vacuum pump to evacuate
the chamber. Because an initial vacuum is not created to eliminate
the barrier action of the air present in the chamber, longer exposure
times are typically necessary.
2-8
-------
The design features and operating procedures of atmospheric
chambers identified in the course of this study vary widely. Four
manufacturers of such chambers have been identified. Ben Venue and
Castle-Sybron manufacture small chambers which are used primarily in
health care and health diagnosis facilities.* These chambers are
unvented and utilize unit dose cartridges containing gas mixtures.
In both cases, as the vaporized ETO enters the chamber, it displaces
air which is directed out the top of the chamber. In the Ben Venue
chambers, a charcoal absorbant is incorporated into the chamber top
to capture escaping ETO. No absorbant or other diversionary device
is incorporated into the relief valve of the Castle chamber.
At the completion of the exposure period, the Ben Venue chambers
utilize a manual pumping action (repeated lifting and lowering of
the outer chamber) to force air into the chamber and direct the ETO
through the charcoal absorbant. No venting mechanism or system is
incorporated in the Castle 1500 atmospheric chamber.
AMSCO manufactures industrial chambers which are designed for
the treatment of goods packaged in hermetically sealed plastic wraps,
as such packaging may otherwise be damaged by the vacuum/pressure
*Approximately 4000 Ben Venue sterilizers have been sold since
introduction in the mid 1950s. Of these, approximately 70 percent
were sold to physicians In private practice, 10 percent to podia-
trists, 2 to 3 percent to clinics and approximately 1 percent to
veterinarians (Morgan 1980). Approximately 300 to 350 Castle Model
1500 chambers have been sold, primarily to hospitals (Frechette
1980).
2-9
-------
changes of a typical cycle.* The created goods are exposed to gas-
eous ETO under pressure. After completion of the exposure period,
air, under pressure, is introduced into the chamber as the sterilant
is being exhausted. This is repeated in timed intervals and the
exhausted gases are vented to the outside atmosphere (Gunther 1980).
The Kewaunee chambers are used for fumigation of museum arti-
facts. They utilize pressurized cylinders of ETO gas mixtures and
are mechanically vented to the outside atmosphere (Canellos 1980).
2.2 Other Containment Equipment
2.2.1 Ampule/Liner Bag System
The H.W. Andersen Company markets an ETO sterilization system
consisting of a nongasketed metal container, plastic liner bags,
and glass ampules containing a unit dose of 100 percent ETO. These
systems have been marketed for approximately 15 years.** They are
available in three configurations: a cylinder and tray, each with
approximately 0.3 cubic foot capacity, and a 2 cubic foot cabinet.
To operate this system, a new liner bag is spread out in the
container. The goods to be treated are placed in the liner bag along
with an ampule which has been broken along a prescored section. The
liner bag is then closed with a twist-tie and the container is closed
*Approximately 100 to 150 such chambers have been manufactured
(Spoden 1980).
JL J*
Approximately 10,000 units have been sold over that period and
approximately 15 million cycles have been operated over that time
(Hamlin 1980a,b).
2-10
-------
and locked with a key. The container and its contents are left un-
disturbed for 12 hours after which the container is unlocked and the
materials removed (H.W. Andersen Products undated a).
This sterilization system is not designed to retain the vapor-
ized ETO. The liner bag is intended to serve as a diffusion mem-
brane, retaining the ETO for a period sufficient to sterilize the
contents and then enabling the ETO to escape slowly into the con-
tainer and subsequently into the surrounding air. The non-gasketed
container is primarily intended to serve as a guard against inad-
vertent ignition of the contents by a spark or open flame during
the treatment process. Because ETO is designed to slowly escape
from the Amprolene containers, the manufacturer recommends that the
container be placed in a well-ventilated area (H.W. Andersen Products
undated a).
2.2.2 Single Item Sterilization System (Sterljet®)
The Sterijet® system, manufactured by H.W. Andersen Products,
is designed to sterilize individual items packaged in sealed pouches.
This system is marketed to hospitals and industrial users, and con-
sists of a machine to deliver a premeasured quantity of sterilant,
plastic pouches in several sizes, and an aeration cabinet.
The operating sequence involves the following steps. The item
to be sterilized is placed in an appropriately-sized pouch. The open
ends of the pouch are then placed around a nozzle which protrudes
between the two sealer pads of the gas delivery machine. The machine
2-11
-------
is activated by depressing a foot pedal which closes the sealer pads
around the package edges and the protruding nozzle. A slight vacuum
is drawn in the pouch and a premeasured quantity of sterilant is
injected; the quantity is dependent upon the size of the pouch being
used. After the sterilant is injected, the nozzle is automatically
withdrawn and the package is heat sealed. The sealed package is
then placed directly into an aeration cabinet or in a temperature-
controlled aeration room where both sterilization and aeration take
place. Sterilization is completed in 12 hours at elevated tempera-
ture (122°F) and aeration is completed after an additional 36 hours.
The pouch is designed to retain the ETO for a period sufficient
to assure sterilization. During the sterilization period, ETO slowly
eludes from the pouch so that at the conclusion of 12 hours the pack-
age has a vacuum-tight appearance. The vacuum tight appearance, de-
signed to provide assurance of package integrity, is maintained until
the package is opened for use or until the pouch is inadvertently
pierced (Andersen 1980).
2.2.3 Tarpaulin Fumigation
Large tarpaulins, composed of gas impervious material,* may
serve as temporary enclosures to contain the gaseous fumigant. Such
containment systems are used almost exclusively at ports of entry for
the fumigation of cargo infested with snails or certain plant disease
*Tarpaulins may be vinyl, rubber coated nylon, or polyethylene.
2-12
-------
organisms. Available information does not indicate that ETO tarpau-
lin fumigation is conducted at any other site of use.
Equipment and procedures used in tarpaulin fumigation are speci-
fied in the U.S. Department of Agriculture (USDA) Plant Protection
and Quarantine Programs Treatment Manual (1976).* Treatment is
conducted by commercial fumigators and supervised by USDA inspectors.
The equipment used in tarpaulin fumigation consists of a tarpau-
lin without visible holes or tears, sand snakes or other means of
sealing the edges of the tarpaulin,** a gas sampling and monitoring
system, and the sterilant supply and delivery system. Fans to circu-
late the sterilant mixture and to aid in its removal are occasionally
used. The sterilant formulation used is a mixture of 10 percent
ETO/90 percent carbon dioxide.
The fumigation procedure is conducted away from normal work
areas, either outdoors or in large buildings such as hangars or
maintenance garages. The material to be treated is placed on an
impervious surface and a wooden frame or other support system is
constructed around it. The frame is designed to keep the tarpaulin
2 feet above the load to facilitate proper gas circulation. Fans to
assist gas circulation, the sterilant supply line, and gas sampling
lines are then positioned within the load. Any protrusions which
*Sections III, parts 1 and 4 and Section IV parts T402 and T403
are applicable to ETO fumigation.
Sand snakes are sleeves or tapes of canvas or heavy—gauge poly-
ethylene filled with sand.
2-13
-------
may penetrate through the tarpaulin, are cushioned with burlap and
the tarpaulin hung loosely over the frame. The perimeter of the
tarpaulin is then sealed with sand snakes, loose wet sand, or mastic
sealer. Corners are frequently sealed with double sand snakes.
After inspection to verify the integrity of the enclosure, the
fumigant mixture is introduced. If the entire cylinder is to be used
it may be placed within the enclosure and the valve opened through
the slack of the tarpaulin.
During the exposure period the gas concentrations within the
enclosure are sampled at intervals to verify adequate concentration
and dispersion. If there is evidence of a leak, a thermal conduc-
tivity analyzer or colorimetric gas detector tubes (see Section 3.0)
are used to locate the source, which is then sealed.
At the conclusion of the fumigation period, the sterilant is
vented from the enclosure by means of fans. These may be suction
fans connected to large ducts which lead out from the tarpaulin or
the fans used to circulate the ETO during exposure. When the latter
are used, operators wearing respirators first cut or loosen the tar-
paulin seal. After the enclosure is evacuated, verified by measure-
ments taken from the sample lines extending from the enclosure, the
operators return to remove the tarpaulin. Some fumigators then wait
an additional 30 minutes to 3 hours before returning to the site for
final clean up.
2-14
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2.3 No Containment Equipment
Fumigation with ETO may also be accomplished in circumstances in
which no separate containment equipment is used. In these instances
the object being treated also serves as the containment equipment.
This treatment technique is primarily applicable to the fumigation of
seriously infested railroad cars.*
A standard procedure is followed in the fumigation of railroad
cars. Cars to be fumigated are moved to a separate track and a
contract exterminator is employed for the task. All food and food
related items are removed and all openings other than an exit door
are sealed with gum tape. A cylinder containing a mixture of 10 per-
cent ET0/90 percent carbon dioxide is placed in the car. The valve
is opened, the operator exits, and the door is sealed. Signs are
placed around the car which indicate that fumigation is in process.
After the exposure period, which lasts approximately 6 hours, the
tape is removed, doors are opened, and the car is permitted to air
for a period of approximately 2 hours. Operators wear respiratory
equipment during periods of possible exposure to the fumigant
(McKenzie 1979).
*0ne instance of ETO fumigation of an entire library building was
reported by Griffith (1979) in MITRE document Preliminary Benefits
Analysis of Ethylene Oxide as a Fumigant in Libraries (Goldgraben
1980).
2-15
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2.4 Summary
Table 2-2 summarizes information regarding commercially avail-
able ETO sterilization/fumigation equipment. For each manufacturer
of such equipment, information is presented regarding chamber size,
sterilant formulation used, sterilant delivery system, chamber vent-
ing system, and other features related to worker exposure. In addi-
tion, the primary markets are identified as well as estimates of the
units sold or currently in use. Where several markets are noted,
these are arranged in order of Importance.
2-16
-------
TABLE 2-2
SOMUE? (V ETO STERILIZATiaS/FOGGAnCH BQDIHCKHT
Type of
Equipment
Nannfacturer
Model
Sice
(ft3)
Sterllant
Focwlation
Sterllant
silvery Systea
Chaaber Venting
Features Relative
to Worker Exposure
Coament*
Site and
Extent of Use
Reference
Vacuum Chaabers
Advanced Instruaentt
Inc.
Needhaa, Heights,
MA.
G1
62 - Mark III
G2 - Mark IV
1
2
4
190X ETO
Cartridge
Chaaber vented to
ataosphere or
(optionally) into
damp sponge8.
Door cannot be opened
during cycle due to
vacuus.
No longer markets
sterilizers; ser-
vices existing
:haabers.
Hospital Inhalation
Therapy Centers
ECRI 1975;
SCOB 1980
Aadek Corporation
Hudson, HA.
Sterldoae
2
100Z ETO
Cartridge
Chaaber vented to
ataosphere or
(optionally) into
damp sponge8.
Door cannot be opened
during cycle due to
vacuum.
y Installation of
laproved seals and
ioor gaskets and
>y installation of
air wash cycle.
Hospitals
Inhalation Therapy
Centers
Central Supply
(approximately 150
units are currently
in use)
ECRI 1975;
Melanson 1980
American Cystoscope
Makers, Inc. (AOtl)
Stamford, CT.
GS 10
2
L00Z ETO
Cartridge
Chaaber vented to
ataosphere or
(optionally) into
damp sponge8.
)oor lock.
to longer narkets
sterilizers; ser-
vice and parts are
.raavailable.
Hospitals
Physicians in private
practice
ECRI 1975;
Spued 1980
Aaerican Sterilizer
Corp. (AMSCO)
Erie, PA.
i
Portagas
2
122 ETO/
881 Freed®
Cylinder
}ptional vent to
ataosphere.
-
-
Hospitals
ECRI 1975;
AMSCO 1980
Eagle 2025
Eagle 2035
Eagle 2045
Eagle 2055
e.a
16
24
30
12Z ETO/
58Z Freon®
Cylinder
Vent to drain.
Automatic leak aonltoring
systea.
lultiple dost-vacuus
exhaust.
fetal carts or wire racks
available as options.
Automatic door(s) avail-
able as option.
Current series in-
troduced in
February 1979.
Hospital Ceotral
Supply
Research Laboratories
(approximately 3600
chanters in use)
AMSCO 1979;
Spoden 1980
fedalllon Series
N.I.
2Z ETO/
J8T ?reon®
Cylinder
7er.t to drain.
ta> post-vacuums standard
feature.
Marketed froa 1965
to 1979.
Hospitals
Research Laboratories
Spoden 1980
Cryothen Series
H.I.
21 ETO/
ttZ Freoo®
Cylinder
Vent to drain.
N.I.
-
Hospitals
Research Laboratories
Spoden 1980
r
Industrial
up to
1100
2Z ETO/ A
181 Freon®
Cylinder
Vent to drain.
Same as standard sized
units.
-
Industrial facilities
(approximately 300-
350 chaabers)
Chamberlain
1980
Spoden 1980
k/crJy Pacific
iorp.
Burbank, CA.
M.A.
100 to
1500
00Z ETO
22 ETO/
J8Z Freon®
OX ETOf
HH C02*
Cylinder
Vent to drain.
Dependent upon custoaer
specifications.
Pharmaceuticals
Medical Products
Food Products
(approximately 60-70
chaabers have been
sold).
Siaa 1980
-------
TABLE 2-2 (CONTINUED)
N>
I
M
00
Type of
Equipnent
Manufacturer
Model
Size
(ft3)
SteriLaot
Formulation
Sterilant
Delivery System
Chamber Venting
Features Relative
to Worker Exposure
Comments
Site and
Extent of Use
Reference
Vacuus Chambers
(continued)
Castle-Sybron Corp.
Rochester, IfY.
3040; 3045; 3145
3240; 3260
4040; 4060
8.8
24 or 30
39 or 71
12% ET0/
882 Freoi^
Cylinder
Vent to drain.
Modified evacuation svs-
tem (pulsating post-
vaccuffl) available as
option in new chamber and
retrofit in existing
chambers.
Liquid-gas separator
available a£ option for
installation into vent
line-
Hospital Central
Suoplv
Industrial
Research Laboratories
(approximately 2500
chambers have been
sold, primarily to
hospitals)-
Frechette 1980;
Weidrich 1980
Environmental
Tectonics Corp.
Southampton, PA.
Industrial
200-1000
lOQZ ETO
12X ETO/
882 Preon®b
Cylinder
Vent to drain.
Dependent upon customer
specification.
Medical Products
Pharmaceuticals
Foods Products
(approximately 100
chambers have been
sold)
D'Aquila 1980
Miskoe Engineering
Concord, NH.
N.A.
49
102 ETO/
902 CO
122 ETO/
882 Freon®
Cylinder
Vent to atmosphere.
Miskoe chambers
are typically
located outdoors.
Beehive Fumigation
Miskoe 1980
3M Corporation
St. Paul, J(H-
100
200
1
2
1002 ETO
Cartridge
Vent to atmosphere.
External cartridge veil.
Operates under negative
pressure throughout cycle.
Manufactured by
Amdek for 3M
(1967-1971);
ceased sale of
reconditioned
units in 1974.
Hospitals
Inhalation Therapy
Centers
Operating Rooms
Industrial
contact lens
manufacturers
interoccular lens
manufacturers
(approximately 3000
chambers have been
sold).
Ackert 1980
202
400
2
4
1002 ETO
Cartridge
Vent to atmosphere.
Automatic cartridge
puncture.
Latter units include
modified evacuation sys-
tem (continuous purge).
Door lock.
Operates under negative
pressure throughout cycle
Model 400 intro-
duced in 1969.
Model 202 intro-
duced in 1974.
Continuously modi-
fied until 1978
when this series
was discontinued.
Ackert 1980
202&
400B
2
4
1002 ETO
Cartridge
Vent to atmosphere.
Heated air vash (continu-
ous purge) evacuation
cycle.
Automatic abort due to
insufficient initial
vacuum; leak to chamber,
door not properly sealed.
Introduced in 1973
Ackert 1980
Mack 1980
-------
TABLE 2-2 (CONTINUE))
Type of
Equipment
Manufacturer
Model
Site
(ft*)
Sterllant
Formulation
I Sterllant
Delivery System
Chamber Venting
Features Relative
to Worker Exposure
Comments
Sice and
Extent of Use
Reference
Vacuus Chubers
(concluded)
Vacudyne Altalr
Chicago Heights, IL
Vacufume - 18
Vacufume - 36
VPS - 100
18
36
100
12? ETO/
882 Freon®
Cylinder
Vent to atmos-
phere or drain.
Operates under negative
pressure throughout cycle-
Libraries
Archives
4useuns
(approximately 50-60
'chanters have been
jsold)
Marklnson 1979
Industrial
100-
1500
1002 ETO/
12* ETO/ .
88* Freon®
Cylinder
Vent to drain.
Dependent upon customer
specifications.
Medical Products
iPharnaceut icals
^approximately 250-
[275 chambers have
jbeen sold)
Harkinson 1980
VernitroD-Better
Built
Carlstadt, KJ.
Standard
4
9
18
24
30
122 ETO/
882 Freon®
Cylinder
Vent to drain.
Hospitals
Research Laboratories
Edick 1980
Kreyling 1980
Custoa
39
70
167
196
12Z ETO/
88Z Freon®
Cylinder
Vent to drain.
Mullple post—vacuuas.
Industrial
Edick 1980
Kreyling 1980
\taosphere
Chambers
American Steriliser
Corp. (ANSCO)
Erie, PA.
Industrial
up to
1100
122 ETO/
882 Freed®
Cylinder
Vented to
atmosphere.
Compressed air introduced
during evacuation stages.
Balanced pressure
cycle used to pre-
serve packaging
integrity.
Industrial
(approximately 100-
150 chambers have
been sold)
Gunther 1980
Spoden 1980
lea Venue Laboratories
Inc.
Bedford, OH.
B.A.
0.04
202 ETO/
80S Freon®
Cartridge
Invented.
Charcoal absorbant
designed to capture
escaping ETO. Manually
operated.
Introduced in
1956.
Physicians In private
practice
Korgan 1980
^astle-Sybroa Corp.
Rochester, KY.
1500
1.3
122 ETO/
882 Freon®
Cartridge
invented.
Door may be opened during
cycle.
Hospitals
(approximately 300-
350 chambers have
been sold)
ECRI 1975
Frechette 1980
ievaunee Scientific
Equipment Corp.
Adrian, MI.
M.A.
100-
196
102 ETO/
902 COz
122 ETO/
882 Freon®
Cylinder
Tented to
ataosphere.
Museums
Canellos 1980
Other Containment
Eqaipaeot
1. W. Andersen
Products
Oyster Bay, MY.
AH 70
AH 72
AH 74
0.3
0.3
2
1001 ETO
Glass anpule
Invented.
Hon-g&sketed container.
Hospitals
Laboratories
Clinics
Physicians in private
practice
(approximately 10,(KK
units have been sold)
H. W. Andersen
Products undated
Baal In 1930b
Sterljet®
N.A.
12Z ETO/
88Z Freon 11
Automatic
delivery system
directly into
plastic pouch.
Pouches placed
In aerator during
sterilization and
aeration period.
Gas delivery aystea
equipped with exhaust
vent.
Single item steri-
lization system.
Hospitals
Industrial
H.W. Andersen
Products 1980a
-------
TABLE 2-2 (CONCLUDED)
N.A. - Not applicable.
N.I. - No information available.
Original recommendation offered by manufacturer; may no longer be observed by users.
Jj
Dependent upon customer specifications.
NJ
i
Isj
o
-------
3.0 ENVIRONMENTAL ETO MONITORING
Measurement of ambient ETO concentrations may be conducted for
various purposes:
• To determine actual levels to which workers are exposed
• To determine if applicable exposure standards are being met
• To evaluate the work environment by locating release sources
and potentially high exposure events
• To verify the performance of control equipment or measures
• To alert workers in the event that ambient concentrations
exceed predetermined levels
The choice of monitoring equipment is dependent upon the purpose
of the measurement. Equipment and techniques used to monitor ambient
ETO concentrations may be classified into two categories: personnel
monitoring and area monitoring.
3.1 Personnel Monitoring
Personnel monitoring techniques are used to determine the actual
levels of ambient ETO to which workers are exposed and to verify
compliance with applicable ETO exposure standards. Such techniques
entail the use of a collection device which Is affixed to the worker
and worn throughout the workshift or for a specified period of time.
The collected samples are then analyzed In a laboratory to determine
an integrated value of exposure over the sample period. This value
represents a time weighted average (TWA) exposure.*
*The current U.S. Occupational Safety and Health Administration
(OSHA) 8 hour TWA for occupational exposure to ETO is 50 ppm.
3-1
-------
Three basic types of collection devices may be used to determine
worker exposure to ETO: (1) sorbent tube containing activated char-
coal, (2) gas bubble tube containing a liquid medium, and (3) sample
bag. Specific information regarding these techniques, including ana-
lytical methods and the advantages and disadvantages associated with
each, are summarized in Table 3-1.
The sorbent tube collection method is most commonly used to
measure personnel exposure to ETO. The sorbent tube(s) containing
activated charcoal are affixed to the worker near his breathing zone
and connected via tubing to a small battery-operated pump worn at
the waist* The pump draws a known volume of air through the tube and
the ETO present in the air sample is adsorbed by the charcoal. After
conclusion of the sample period, the tube is removed, capped, and
sent to a laboratory for analysis. The analytical method entails
desorptlon of the ETO, either with carbon disulfide or thermally, and
subsequent gas chromatographic determination.
Three variations of the charcoal tube method are currently in
use. These variations are primarily associated with the actual con-
figuration and dimensions of the sorbent tubes (Table 3-1).
Impingers (gas bubble tubes containing a liquid medium) may be
used. These are affixed to the worker in a manner similar to the
attachment of charcoal tubes. Essentially, such collection devices
convert the ETO in the air sample to ethylene glycol (ETG) in a di-
lute sulfuric acid medium followed by neutralization with 50 percent
3-2
-------
TABLE 3-1
SOOCMEZ 0* ETO PKtSGOAL MQHtTO&ZBC TBCHHiqOKS
CO
I
OJ
Sample Collection Method
Analytical Method
Coaments
Reference
Sorbent Tube Using Actlved Charcoal
- MIOSH Method (2 tubea In series; adsorbing
tube contains 400 ng charcoal and back up
tube contains 200 ng charcoal).
- OSHA Method (2 tubes in series; each
contains 150 ng charcoal).
- Qazl-Cetcham Method (1 tube; front section
contains 700 ng charcoal and back up sec-
tion contains 390 ng chsrroal).
- Desorptioo with carbon disulfide and
gas chromatographic determination-
or
- Thermal desorptloa snd gas chromato-
graphic determination.
Advantages
- Small, portable sampling device-
- Minimal Interferences.
Disadvantages
- Breakthrough can occur.
- In areas with greater than 60
percent relative humidity, 10 to
40 percent ETO loss found with
sample voluae >10 liters.
- Hot suitable for extremely short
sampling periods (<15 min.)
- Inquires cold trsnsportatlon snd
storage conditions.
Amato 1980;
Glaser et al. 1977;
MIOSH 1976;
SEC 1980;
Qazi and Ketcham 1977
Inpinger (gas bubble tube rrnifsinlng liquid
medium)
- fcsmo Method (ETO converted to ETC in a
0.11 sulfuric add solution).
- Bolton Method (ETO converted to ETC in 20
percent sulfuric acid solution).
- Neutralisation of absorbing add
solution with 501 potasslom hydroxide
and gas chromatographic determination.
- Oxidation to formaldehyde and colori-
metrlc determination based on reac-
tion with sodlta chromotropate.
Advantages
- Absorption efficiency not sub-
ject to ambient air temperature
or relative humidity.
Disadvantages
- Cnbersome sample apparatus.
- Vet method analysis. (Bolton
method).
- Possible spillage during sampling
and transfer.
- Inquires correction for
evaporation.
Amato 1980;
Glaser et al. 1977
Romano and Rentier 1979;
SEC 1980
Sample Bag (Tedlar)
- Gas chromatographic determination.
Advantages
- Suitable for full shift or short
term (5 minutes or less) samples.
- Ho sample loss at 50 ppm ETO
during 5 day storage period.
- Ho need to transport under cold
conditions.
- Bsgs are reusable.
Disadvantages
- Bulky sample apparatus.
- Possible penetration by sharp
object.
Amato 1980;
SRC 1980
-------
potassium hydroxide and gas chromatographic determination (Romano
method) or oxidation to formaldehyde which is determined colorimet-
rically by its reaction with sodium chromatropate (Bolton method)
(Glaser et al. 1977; Romano and Renner 1979).
Alternatively, a sample bag (Tedlar bag) may be worn by the
worker and connected to a sample tube which terminates near his
breathing zone. The pump draws a known volume of air from the
vicinity of the breathing zone into the bag where it is collected.
A sample of the air mixture is then removed from the bag for gas
chromatographic determination.
In general, personnel monitoring techniques have the following
advantages and disadvantages (Opp 1980):
• Advantages
- Readily portable
- Extremely sensitive
- Specific for ETO
- Provide a time weighted average measure of exposure
- Monitor actual personnel exposure
• Disadvantages
- Require laboratory analysis
- Time delay in obtaining results
- Results do not specify source or event associated with
exposure
- Integrated values may mask short term exposure to high
ETO concentrations
3.2 Area Monitoring
Monitoring ambient ETO concentrations in the general workplace
can be performed by the use of direct reading Instruments. Such
instruments, whether portable or fixed continuous monitors, provide
3-4
-------
an immediate quantitative indication of the ambient ETO concentra-
tions in the vicinity of the sample probe. The indication mechanism
may be a meter, strip chart recorder, tape printout, or a color
change in an indicator tube (Keenan 1973). Such equipment may be
used to determine peak concentrations (within the range limits of the
particular instrument), to determine changes in concentration over
time, and to determine concentrations at different locations within
the work area. Portable units may, in addition, be used to identify
leak sites while fixed, continuous monitoring networks may incorpo-
rate an alarm to notify personnel in the event that ambient ETO con-
centrations exceed predetermined levels.
Table 3-2 summarizes the types of direct reading instruments
currently available for ETO monitoring. For each instrument, infor-
mation regarding detection range, specificity, and response time is
presented.
In general, the limitations associated with such hardware are
related to specificity. Most direct reading instrumentation iden-
tified in the course of this study detect contaminants other than
ETO, thus providing a potentially inaccurate measurement of ambient
ETO concentrations. The nature of the interfering compounds varies
with the type of instrumentation (Table 3-2).
The most commonly used type of direct reading instrumentation
for area monitoring of ETO concentrations is the infrared gas ana-
lyzer. Such analyzers are available as portable units from the
3-5
-------
TABLE 3-2
SELECTED ETO AMBIENT MONITORING INSTRUMENTATION
Operating
Principle
Manufacturer
Detection Range
(Ppm)
Specificity
Response Tlae
Portability
Raaaxks
Reference
Combustible Cat
Detection
Bachsrach Instruasnc
Coapany
1-10,000
Detect! any com-
bustible gas.
30 seconds
Portable (5.5 lbs.).
- Factory calibrated
for haxane; con-
version faetor
ussd for reading
other gaeee.
- 3 eceles (1-100,
1-1,000, 1-10,000)
with aster reedout.
Bachsrsch Instruaent
Coapany 1977;
McDeraott 1980;
Opp 1980
ENHBT Corporation
1-100
Verlee vlth
application'
Portsble (1.4 lbs.).
- Alera level at 100
ppa.
Donkln 1960;
Opp 1980
'
Rexnord Gas Detec-
tion Products
3,000-30,000
40 seconds
Flxad.
- Reaote aonltorlng.
Allaan 1900;
Opp 1980
Sutglcot Company
-•SO ppm
S.I.
Portable <2 lbs.).
- Naa-quantitAtlv*
- Leak detection.
Gardner 1980
Caa Tech Inc.
20-1,000
N.I.
Portable or Fixed,
multipoint.
- Meter readout on
porteble unit.
- Fixed unite have
lmr (15-20 ppa)
and upper elsra
settings but no
aeter reedout.
Pellleeler 1980
Colorlaetry
National Dreeger,
Inc.
25-500
Interference by
propylene oxide,
ethylene,
ketonesi alde-
hydes, or asters.
8 alnutea
Portable (I to 1.5
lbe.).
- Accurate to within
IS percent.
- Reed aa leagth of
discoloration elong
cellbrsted scale.
- Hand operated bel-
low pustp used to
obtain grab staple.
Planing 1980;
SKC Inc. 1980
SKC Inc.
Flame Ionisaclon
Caa Chroaetography
Century Syeteae
Corporation
0.5-1,000
(total
organic
vapor)
Detecta total
organic vapora
if GC is not
uaed. Specific
to ETO In OC
¦ode 11 there
are no coapounds
with a similar
retention tine In
the air staple.
2 seconds
(FID)
Portable (12 lbs.).
- Meter reedout in
FID aode.
- Audible alera.
- Optional strip
chert recorder.
- Selective abaorbast
filter for lsopro-
panol available for
operation in FID
aods vlth 30-40
second response
tiae.
Century Syeteae Corpo-
retlon, undated;
Morrle 1980;
Opp 1980
Infrared
Spectrophotometry
Beckaan Instruaente
>50
Interference by
freon&at 11. ft U*»
and alcohol at
1 second
Fixed.
- Procees
applications.
Houben 1979;
Opp 1980
Foxboro/Wilke
1-1,000
3.3 tin.
15 seconds
Portable (IB to 32
lbe.) or Fixed,
Multipoint.
- Llaited eccurecy
below 10 ppa.
Opp 1980;
Venell 1990
Mine Safety
Aosliences Co.
4-12,000
45 aeconda
Fixed.
-
Opp 1980
Photolonlfcation
KNu Systems
0.1-2,000
Interference by
any compound that
lonizee below 0.5
electronvolta.
8 seconds
Portable (91ba.) or
Fixed.
- Requires dally
recalibrstlon.
Downey 1980;
Opp 1980
Solid Scat* Sensor
1
International Sansor
Technology
1-150
Interference by
CO)i hydrogen,
or SMKMl*.
60-90 seconds
Portable (3 to 4
lbs.) or Fixed.
- Non-linear scale
- Slow (5 nlnutee)
clearance to 0
when operated
continuously.
Krell 1980
N.I. - No lnforastlon.
3-6
-------
Foxboro Company and as fixed, multi-point, continuous monitoring
networks from Foxboro, Beckman Instruments, and Mine Safety Appli-
ances, among others.
Infrared analyzers detect ETO concentrations in a continuous
air sample by measuring the amount of infrared energy absorbed by
the compound at selected infrared wavelengths# Two such wavelengths,
11.8 (Jim and 3.3 (j.m, are used for ETO monitoring. At the former wave-
length, there is interference with Freon®, a common non-flammable
carrier in ETO-gas mixtures (Opp 1980; Roy 1980b).
Other types of direct reading instruments available for ETO
monitoring include combustible gas detectors, colorimetric indicator
tubes, and instruments utilizing flame ionization and photoionization
detection.
Combustible gas detectors may use resistivity or thermal con-
ductivity as the operating principle. Resistivity instruments uti-
lize a filament heated above the ignition point of the substance of
interest. The resultant heat of combustion changes the resistance
of the filament. When the filament is part of a bridge circuit, the
resulting measurement of the imbalance in resistance is related to
the concentration of gas in the sample mixture. Thermal conductivity
instruments measure the loss of heat from a hot filamemt. The loss
results in a decrease in electrical resistance in the sample cell
relative to that of the reference cell (Keenan 1973). Such instru-
ments are generally non-specific.
3-7
-------
Direct reading colorimetric devices utilize the chemical proper-
ties of the substance of interest for reaction with a color-producing
reagent. A sample of air is drawn into an indicator tube containing
solid reagent chemicals by means of a hand operated pump. The
resulting color change is indicative of the presence of the suspect
contaminant; the concentration is read as the length of the color
stain along the graduated tube (Keenan 1973). Such devices are very
portable and relatively simple to operate; however, they only detect
the concentration of gas in a grab sample and thus do not provide
data regarding concentrations of ETO over time. In addition, false
positives due to similarly reacting interferences may occur (Fleming
1980).
The flame ionization detector (FID) is a stainless steel burner
in which hydrogen is mixed with the sample gas stream. Oxygen is
then diffused around the jet through which the hydrogen-gas mixture
flows. The mixture is ignited on a cathode tip and a loop of plati-
num serves as a collector electrode. The current passing across the
gap between the cathode and electrode is proportionate to the number
of ions generated during ignition (Keenan 1973). The FID detects
total organic vapors, has a low noise level and high sensitivity, and
is used as the detector in portable gas chromatographs (Glaser et al.
1977).*
*The Century Systems Corporation offers a selective absorbant fil-
ter to be placed in the input line of FID which is designed to stop
the isopronal vapor (Freon®) while permitting the ETO to pass
through. Use of this filter permits continuous direct read-out of
ETO in the presence of Freon® as an interference (Century Systems
Corporation undated).
3-8
-------
One manufacturer, Century Systems Corporation, recently pur-
chased by Foxboro-Wilks, offers a portable gas chromatograph (GC)
for use with their flame ionization instrument. The FID is intended
to be used in a survey mode to locate the area of concentration of
organic vapors. The portable GC is then used to identify the spe-
cific contaminant and determine its concentration in the sample.
Gas chromatography is a physical process for separating the com-
ponents of a complex mixture. It is based on the varied affinities
of the sample components for the packing materials of a particular
column. The area of the peak recorded on the strip chart is used
to measure the concentration of the sample component (Keenan 1973).
Since every chemical has a specific and unique affinity for the
packing material in the column, different chemicals are resolved
into separate peaks, each at a characteristic location (in time)
that allows identification of sample components.
Photoionization instruments are similar in operation to flame
ionization detectors. They differ, however, in that an ultraviolet
light source, rather than a flame, is used to ionize the gas mole-
cules (Downey 1980).
3.3 Summary
Determination of ambient ETO concentrations may be accomplished
by the use of personnel monitoring techniques or by direct reading
instrumentation. Personnel monitoring entails the use of a col-
lection device and subsequent laboratory analysis. Such techniques
3-9
-------
are used primarily for the determination of actual levels of worker
exposure over the sample period and provide an integrated exposure
value (time weighted average). These techniques, however, are lim-
ited because there is a time delay in obtaining results, the results
do not specify the source or event associated with exposure, and the
integrated values may mask short term exposure to high ETO
concentrations.
Direct reading instruments (both fixed and portable) may be
used to provide an immediate quantitative determination of ETO con-
centrations in the vicinity of the sample probe. Such instruments,
including combustible gas detectors, colorimetric indicator tubes,
and devices utilizing flame ionization, infrared spectrophotometry,
and photoionization detection mechanisms, are used to evaluate the
work environment and, if equipped with an alarm, to notify workers
in the event that ambient ETO concentrations exceed predetermined
levels. The major limitation associated with direct reading instru-
ments is the lack of specificity; contaminants other than ETO can be
detected thereby resulting in a potentially inaccurate measurement of
ambient ETO concentrations.
3-10
-------
4.0 WORKER EXPOSURE TO ETO
This section identifies the sources and circumstances associated
with worker exposure to ETO and summarizes data estimating the extent
of such exposure. Much of the information presented in this section
is derived from published data regarding worker exposure at hospital
facilities, particularly those using vacuum chambers. Limited data
were available which characterize and quantify worker exposure at
other sites of use. At some sites, particularly at industrial ETO
facilities, monitoring programs have been conducted; however, the
resulting data are typically considered to be proprietary and there-
fore were not made available. In addition, it was found that assess-
ments of worker exposure were usually not conducted at other sites
(see Appendix C).
Three categories of workers may be exposed to ETO: chamber
operators, repair and maintenance personnel, and other workers sta-
tioned in the general vicinity of the ETO equipment. Chamber oper-
ators may be exposed to ETO while unloading the chamber and handling
treated goods. Maintenance personnel may be exposed while perform-
ing routine functions such as replacing depleted sterilant cylinders
and, less frequently, while performing repairs resulting from equip-
ment breakdown or system malfunction (active exposure). These per-
sonnel, as well as others stationed in the general vicinity of ETO
equipment, may be exposed to elevated ambient ETO concentrations
resulting from a number of sources of release (passive exposure).
4-1
-------
Table 4-1 summarizes data regarding worker exposure to ETO at 23
California hospitals. Included is information regarding active
exposure levels to workers while unloading the sterilizer, work
practices, ambient ETO concentrations at nearby workstations, and
identification of some sources of ETO release to the workplace.
The following discussion of sources and circumstances associated
with worker exposure to ETO differentiates between common sources
(those which may occur in the normal course of ETO treatment), and
uncommon events. Within each category, sources and events associated
with worker exposure are discussed in temporal order.
4.1 Common Exposure Sources and Events
Common sources of ETO release to the workplace occur in the
course of normal operations. Workers may be passively exposed to
ETO from leaks in the gas delivery system, the chamber, and vent
connections. In addition, ETO is released during the exhaust phase
of the cycle from chambers which are vented to a sewer drain as well
as from chambers which vent directly into the workplace.* After
completion of the cycle, operators may be actively exposed to ETO
when opening the chamber door, unloading treated goods, and trans-
ferring them to storage and aeration facilities. Offgassing from
treated goods in storage and from unvented or poorly vented aeration
cabinets may present a further source of chronic ETO release to the
*While such leaks are not expected to occur in the normal operation
of a well maintained sterilizer/fumigator, they are sufficiently
common to warrant consideration as routine sources of release.
4-2
-------
TABLE 4-1
ETO WORKER EXPOSURE AT SELECTED CALIFORNIA HOSPITALS®
Average Operatoi
Exposure During
Unloading and
Transfer
(pp">
Operator
Practices
Background Exposure .
at Staff Work. Stations
-------
TA»t2. 4-1 (CONTINUED)
Average 0
Exposure
thiloftdifi
Trans
¦ (pt»
perator
During
% and
fer
)
Operator
Practices
Background Exposure .
at Staff Work Stations
(PP")
Sources of Workplace
Release of ET0
Hospital/Area
Equlpaent
Actu*lb
Waits
Before
Unloading
Uses
Gloves
Regular
In-Service
Training
Before
Cycle
During
Cycle
After
Door
Opened
Supply
Lines
Cbaaber
Door
Sterilizer
Vent
Aerator
FK
Prograae
Consents
Respiratory
Therapy
AMSCO
Portages
AKSCO
Aerator
100 for
5 nin.
33
No
No
Tes
8 for
420 ain.
8 for
420 ain.
8 for
420 ain.
No
Minor
leaks
Ho
Minor
leaks
No
Poor ventilation, area never
clears coapletely to 0 ppa.
6. Central
Service".
AMSCO
Sterilizers
(2)
AMSCO
Aerator
60 for
5 ain.
20
Tes
Tes
Tes
N.D.
75 for
20 ain.
95 for
15 ain.
Ho
No
Leaks fro*
vent
Vats to
equipment
Tes
Inadequate cross-ventilation.
Surgery
3H 200
Aerator
3K Aerator
100 for
5 ain.
33
Mo
No
U.K.
55 for
420 ala.
5S for
420 ala.
55 for
420 ala.
H.A.
No
Vents to
rooa
Vents to
work area
Heavy usage.
Small rooa vith poor ventilation.
7. Central
Services
AMSCO
Steriliser
AMSCO
Aerator
50 for
5 ala.
17
Tes
(15 «in.)
Tes
O.K.
H.D.
N.D.
75 for
15 ala.
Leak
HO
Vents to
floor
drain
No
Tes
Only aarglnal ventilation but no
nearby work stations.
8. Surrery
AMSCO
Steriliser
AMSCO
Aerator
100 for
5 ain.
33
Ho
Tes
U.K.
10 for
120 ain.
10 for
420 ain.
10 for
420 ala.
Ho
Ho
Vents
poorly to
drain
No
No
Sterilizer located in high-traffic area.
Inadequate ventilation.
Not enough aerator space available, j
9. Central
Supply
Castle
Steriliser
Castle
Aerator
20 for
5 ain.
7
Tes
CIS ain.)
So
Tes
H.D.
N.D.
45 for
20 ala.
20 for
10 ain.
10 for
5 mis.
2 Leaks
No
Vents to
floor
drain
Vents to
equipment
rooa
Tes
Operators wash down sterilisers with-
out gloves.
Adequate ventilation.
10. Central
Supply
AMSCO
Sterilisers
(2)
AMSCO
Aerator
25 for
3 ain.
5
Tes
(20 ain.)
Tes
No
N.D.
N.D.
N.D.
Major
leaks
1 Leak
Vents to
floor
drain In
equipment
rooa
(Tents to
equipment
rooa
Tes
Ho work stations nearby.
Exhaust veat located above each
steriliser.
11. Central
Supply
Castle
Steriliser
Castle
Aerator
>100 for
S nin.
100
Tes
[15 ain.)
Bo
Bo
N,J>.
50 for
360 ain.
100 for
80 ala.
50 for
180 ain.
Ho
Ho
rents to
floor
drain in
trork area
Vents to
work area
Tes
Inadequate cross-ventilation.
Poorly designed area.
Steaa vents blow ETO out of drain.
-------
TABLE 4-t (COHTISUED)
Average Operator
Exposure During
Unloading ?nH
Transfer
Sources of Workplace
Release of STO
Hospital/Area
Equipaent
Actual1*
15-Wn.
TWA
Halts
Before
Unloading
Dses
Gloves
Regular
In-Service
Training
Before
Cycle
During
Cycle
After
Door
Opened
Supply
Lines
Chaaber
Door
Steriliser
Vent
Aerator
PH
Prograa6
Cooaents
12. Central
Supply
AMSCO
Sterilisers
(2)
AMSCO
Aerator
AO for
J sin.
16
Tes
(15 Bin.)
Tes
Tea
11.D.
100 for
15 sin.
100 for
30 ain.
Minor
leaks
Ho
Vents to
floor
drain in
equipaent
rooa.
No
Tes
Inadequate cross-ventilation.
Fairly even diffusion throughout
entire area.
Steaa vents blow ETO out of drain.
13. Central
Supply
AMSCO
Sterilizer
5 for
5 ain.
2
Tes
(15 Bin.)
No
Ho
H.D.
N.D.
20 for
10 ain.
Ho
Ho
Veats to
floor
drain in
equipaent
rooa.
H.A.
Tes
No enclosed aerator.
Low work load.
Area well ventilated.
14. Central
Sterile
Procedure!
AMSCO
Steriliser
Andersen
Steriliser
Ben Venue
Sterilizer
Aerator
(«annfse-
curer un-
known)
AO for
5 iln.
50 for
3 aia.
23
Tes
(15 aln.)
Ho
Mo
H.D.
H.D.
AO for
30 Bin.
10 for
30 ain.
Ho
All
steri-
lizers
leaked
Vents to
drain In
equipaent
rooa.
Table top
units un-
ventllated.
Vents to
work area.
Tes
Inadequate cross-ventilation.
Aerator Installation poor.
Food exposed.
15. Central
Supply
Castle
Steriliser
Castle
Aerator
fl.D.
H.D.
Tes
(15 aln.)
Tes
Tes
M.D.
H.D.
H.D.
Major
leaks
Ho
Vents to
floor
drain In
equipaent
rooa.
Vents to
equipaent
rooa.
U.K..
Excellent cross-ventilation.
16, Central
Supply
Castle
Sterilizer
Castle
Aerator
H.D.
H.D.
Tes .
(15 Bin.)
Tes
Tes
H.D.
H.D.
H.D.
Ho
No
Vents to
floor
drain in
equipaent
rooa.
Vents to
work area.
U.K.
Good cross-ventilation.
17. Central
Supply
AMSCO
Sterilisers
(2)
AMSCO
Aerator
35 for
5 via.
12
Tes
(15 ala.)
Sqae-
tlaes
Tes
N.D.
H.D.
35 for
10 Bin.
Ho
Ho
Vents to
floor
drain in
equipaent
rooa.
Leaks;
Vents to
work area.
U.K.
Fair ventilation (5 changes/hour).
-------
TABLE 4-1 (CONCLUDED)
Average Operator
Exposure During
Unloading and
Transfer
(pp">
Operator
Practices
Background exposure ,
at Staff Vork Stations
-------
workplace. Finally, workers who replace emptied ETO cylinders may
be actively exposed to ETO which remains in the cylinders and in
the piping system. Depending upon the specific exposure source,
ETO releases may be of relatively short duration or chronic.
4.1.1 Leaks from Gas Delivery Systems
Leaks from tanks, tank valves and fittings may release ETO
to the workplace during the gas charge phase of the cycle. Lim-
ited information is available regarding the levels of ETO release
resulting from such sources. One source reported that leaks pro-
ducing instrument readings ranging from 400 to 3000 ppm were located
(Glaser 1977).
Such leaks may be relatively common. Daley et al. (1979)
reported that in their survey of 23 hospitals, 9 of the 27 ETO cham-
bers examined (33 percent) were found to have leaks in the supply
lines between the ETO cylinders and the sterilizer. Three of these
leaks were considered to be substantial.
4.1.2 Releases During Cycle Operation
ETO releases from the sterilizer/fumigator may occur during the
cycle and may result in prolonged release of ETO to the workplace.
Such releases may be due to leaks in the chamber door gasket or may
be inherent in the design of some atmospheric sterilization units.
4.1.2.1 Leaking Door Gaskets. Door gaskets are intended to
effect a perfect door seal. With time and use, these gaskets may
4-7
-------
crack, harden, or become misshapen and may thus provide a source of
ETO leakage to the workplace during the treatment cycle.
Daley et al. (1979) reported finding evidence of leaks to the
chamber door at five of the 23 (22 percent) hospitals surveyed; how-
ever, levels of ETO release from these sources were considered to be
relatively insignificant. Koketsu et al. (1977) reported ETO concen-
trations ranging from 600 to 1600 ppm around the sterilizer door at
one hospital installation and concentrations of 18,000 to 20,000 ppm
at the sterilizer door at a second hospital ETO chamber. In the
latter facility, ETO concentrations averaging 108 ppm were recorded
3 feet away from the sterilizer over a 45 minute period during the
cycle.
4.1.2.2 Unvented Atmospheric Chambers. Some unvented atmo-
spheric chambers are not designed to provide a complete seal either
during the gas charge phase or throughout the cycle. In such cham-
bers, ETO will be released throughout the cycle and may provide a
chronic source of worker exposure.
Monitoring data supplied by Ben Venue Laboratories are summar-
ized in Table 4-2. These data indicate that ETO is released to the
workplace upon piercing of the cartridge (72.8 ppm over a 12 minute
sampling period) and throughout the cycle (at lower concentrations).
Similarly, the H.W. Andersen Anprolene sterilizers are designed
to permit the slow diffusion of ETO to the workplace. Monitoring
test results supplied by the manufacturer are summarized in Table
4-3.
4-8
-------
TABLE 4-2
ETO RELEASED TO A WORKPLACE DURING
OPERATION OF A BEN VENUE STERILIZER3
Event
to
ETO Concentration
(ppm)
Sample Period
(minutes)
Cartridge Pierced
72.8
12
First half of exposure
period
30.6
150
Second half of exposure
period
5.6
150
Manual pumping action
23.4
12
Open sterilizer and
remove contents
48.9
12
Treated goods and
sterilizer aerating on
benchtop
2.8
120
Calculated 8 hour TWA
15.62
—
Sl
Sterilizer located in 7.2.cubic meter room.
Integrated value over sample time period determined by
NIOSH Analytical method Set T Ethylene Oxide using charcoal
collection tubes.
SOURCE: Morgan (1980b).
4-9
-------
TABLE 4-3
ETO RELEASED TO WORKPLACE DURING OPERATION
OF ANPROLENE AN-70, AN-72, AND AN-74 STERILIZERS3
Model Tested
Event
ETO Concentration^*
(ppm)
AN-70
»
During cycle0
<2
15 Minutes post cycle**
17
Total period
<2
AN-72
During cyclec
<2
15 Minutes post cycle
20.3
Total period
<2
AN-74
During cyclec
4
15 Minutes post cycled
57.7
Total period
5.6
aTests conducted in an 800 cubic foot room with inadequate ventila-
tion. Sterilizers loaded with cloth, which rapidly eludes ETO, to
determine worst-case post sterilization exposure. Measurements
taken continuously by infrared gas analyzer equipped with strip
chart recorder. Sample probe located 2 feet in front of sterilizer
door.
^Represents total amount of ETO released to the workplace over the
sample period divided by the number of minutes in the sample period.
CTwelve hour period.
^During this period the sterilizer and liner bag were opened and the
contents were removed and placed on an adjacent counter.
SOURCE: Andersen (1978).
4-10
-------
A. third sterilizer model whose design results in the release of
ETO during the treatment cycle is the Castle-Sybron Model 1500. In
these chambers, ETO is released from the chamber vent along with the
displaced air during the gas charge phase. Field tests conducted in
an unventilated 1000 cubic foot room detected ETO 1 foot in front of
the sterilizer over a 13 minute period after onset of the gas charge
phase. Peak ETO concentrations recorded during this period exceeded
750 ppm (Bruyer 1979b). Similar field tests were conducted in an
unventilated 1243 cubic foot room and detected peak ETO concentra-
tions ranging from approximately 50 ppm to over 750 ppm (Table 4-4)
(Bruyer 1979a).
4.1.3 Releases During Exhaust Phase of Cycle
In some vacuum chambers, ETO may be released to the workplace
during the exhaust phase of the vacuum cycle from chambers which are
vented to the sewer drain or to the workplace, and as a result of
leaks to vent connections.
4.1.3.1 Discharge to Sewer Drain. Chambers which vent to the
sewer drain may result in the release of substantial quantities of
ETO during the exhaust phase of the cycle. Such releases occur at
the gap between the vent line and the sewer drain.
Roy (1980a) reported that ETO concentrations in the vicinity
of the drain have been found to be approximately 100 to 300 ppm.
However, other sources reported substantially higher concentrations.
Weidrich (1980) has reported that peak ETO concentrations near the
4-11
-------
TABLE 4-4
ETO RELEASED TO WORKPLACE DURING OPERATION
OF CASTLE-SYBRON 1500 ATMOSPHERIC STERILIZER
Test Condition/
Sample Location3
Peak ETO Concentration0
(ppm)
Clearance Time^
(minutes)
Entrance Door Open
12" from sterilizer
counter level**
door/
200
8.2
12" from sterilizer
54" from floor**
door/
50
N.A.
12" from sterilizer
floor level**
door/
>750
11.1
Entrance Door Closed
12" from sterilizer
54" from floor*5
door/
70
32.3
cl g
Test conducted In 1243 ft3 room with no ventilation.
^Monitoring conducted with Wilks-Miran portable infrared gas analyzer.
c
Approximation of data recorded on strip chart*
^Time for ambient ETO concentrations to clear to 50 ppm or below.
SOURCE: Bruyer (1979a)
-------
drain may be as high as 5000 to 6000 ppm. A second source reported
measurement of 4000 ppm at the drain. Concentrations 4 feet above
the drain and 3 feet behind the sterilizer were found to be approxi-
mately 200 ppm (Ruck 1978). Similarly, Koketsu et al.(1977) reported
ETO concentrations ranging from 100 to 8000 ppm at the floor drain
during gas evacuation. In addition, they recorded concentrations
of 140 to 160 ppm in the equipment area at the breathing zone level.
It should be noted, however, that measurements taken in the equip-
ment area behind the sterilizer may not be representative of ETO
concentrations in the general work area. Frequently, particularly
in hospital installations, equipment is recessed into the wall and
the enclosed machinery area is maintained at a negative pressure
relative to the general work area. Nevertheless, ETO released at
the drain during evacuation may diffuse into the general work area
and contribute to background ambient concentrations to which workers
may be passively exposed (Glaser et al. 1977). No specific data were
identified which estimate the extent of worker exposure resulting
from ETO release at the drain.
4.1.3.2 Vacuum Chamber Vented to the Workplace. Some older,
small vacuum chambers may not be installed with a fixed vent line to
the atmosphere. In such installations the vent line may terminate in
the workplace, either directly or into a sponge kept damp in a bucket
of water. Workers may thus be exposed to the ETO which is evacuated
from the chamber.
4-13
-------
While no information was identified in the course of this study
to estimate the current number of such installations, few are pre-
sumed to be in operation.
4.1.3.3 Leaks to Chamber Vent Lines. Vent lines connected from
the sterilizer to the atmosphere or sewer may leak thus releasing ETO
during the exhaust phase of the cycle. Daley et al.(1979) reported
that 1 of the 27 (four percent) ETO chambers examined showed evidence
of such a leak. Concentrations of 100 ppm were recorded over a 15
minute period near the sterilizer vent connection.
Releases after Treatment Cycle
The greatest opportunity for worker exposure, both active and
passive, occurs after the completion of the treatment cycle when the
chamber door is opened and treated goods are unloaded. Unevacuated
ETO present in the chamber rapidly disperses into the workplace when
the chamber door is opened. In addition, residual ETO absorbed or
entrapped in treated goods may present a further source of worker
exposure.
A.1.4.1 Unloading Chamber and Transferring Treated Goods. The
single greatest source of worker exposure to ETO, both active and
passive, is the unevacuated ETO that is released to the workplace
when the chamber door is opened at the conclusion of the cycle
*One research facility contacted in the course of this study
reported that a small vacuum chamber (3M Model 200) had, until
recently, been vented into a damp sponge. Within the past year,
the vent line had been redirected to exhaust gas to the outside
atmosphere (Suffin 1980).
4-14
-------
(Koketsu et al. 1977; Daley et al. 1979; Samuels and Corn 1979). The
amount of ETO that is released is dependent upon the effectiveness of
the chamber evacuation system, if any; the size of the chamber and
the amount of ETO initially charged; the nature of the goods being
treated; and the time delay between completion of the treatment cycle
and opening the chamber door.
Peak concentrations recorded at the operator breathing zone have
been reported to typically exceed 100 to 200 ppm and, on occasion, to
exceed 500 ppm (Roy 1980a; 1980c).* Other sources reported similar
findings, in some instances indicating that such peak concentrations
have exceeded 1000 ppm (Glaser 1977; Ackert 1980; Weidrich 1980).**
Such peak concentrations are typically recorded within 1 to 2 minutes
after the chamber door is opened and generally fall to 10 ppm or less
within 15 minutes (Ackert 1980; Nusbaum 1980). Table 4-5 presents
monitoring data recorded with a portable infrared analyzer indicat-
ing the changes over time in ETO concentration 1 foot in front of
a small (3M Model 200) sterilizer after the chamber door is opened.
Additional data regarding ETO concentrations recorded at various
locations in a hospital central supply facility are presented in
Appendix B.
*These data were reported for small and intermediate-sized steril-
ization chambers such as those typically found in hospital facil-
ities and may not be applicable to larger sized vacuum chambers
and other types of ETO containment equipment.
**Koketsu et al. (1977) reported that average peak concentrations
measured in a survey of four Washington, D.C. hospitals ranged
from 24 to 660 ppm.
4-15
-------
TABLE 4-5
ETO CONCENTRATIONS RECORDED 1 FOOT AWAY FROM
STERILIZER AFTER CHAMBER DOOR OPENED3
Time
ETO Concentration
(ppm)
Initial Opening
2 Minutes
3 Minutes
5 Minutes
385
120
96
Not detectable
Measurements recorded with portable infra-
red analyzer with sample probe located 1
foot from cabinet at breathing zone height.
SOURCE: Corn (1980).
4-16
-------
ETO concentrations may be substantially higher if the chamber
is not opened immediately upon completion of the cycle.* In such
instances, the ETO concentration in the chamber increases due to the
continuing offgassing of residual ETO absorbed or entrapped within
the treated goods. Such increased concentrations will result in a
substantially greater release to the workplace once the door is
opened and may result in higher levels of worker exposure. Table 4-6
summarizes monitoring data which indicate the increased release of
ETO resulting after an hour time delay in opening the chamber door
after completion of the cycle.
A second source of ETO release to the workplace is offgassing
from treated goods during transfer of the load to an aeration cabinet
or storage facility. Koketsu et al. (1977) have monitored the area
immediately around freshly sterilized goods and have reported ambient
concentrations ranging from 17 ppm to 12,000 ppm. A second source
reported that ETO concentrations of over 500 ppm were measured in the
vicinity of products being removed from the sterilizer (Roy 1980c).
The extent to which workers may be exposed to ETO during trans-
fer of treated goods is dependent upon the nature of the treated
goods and their respective rates of offgassing, the method used to
*Such delays may occur in facilities in which the chamber is loaded
at the end of the workday and unloaded the following morning. In
other facilities, such as in some libraries and museums, treated
goods may remain in the chamber for up to 24 hours after completion
of the cycle (see Appendix C).
4-17
-------
TABLE 4-6
ETO CONCENTRATIONS RELEASED TO THE
WORKPLACE ASSOCIATED WITH DELAY IN DOOR OPENING
ETO Concentrations (ppm)
Chamber
Model/Size
Sample
Locations
Door Opened Immediately
Upon Cycle Completion
Door Opened After
1 Hour Time Delay
Reference
£>
1
1—*
00
3H Model 200/
2 ft3
- 12" from chamber/
12" from floor8,
- 12" from chamber/
midpoint of chamber
- 12" from chamber/
72" from floor8
- 72" from chamber/
midpoint of chamber
- Operator Sample
- Average Peak Concentration0
28.7
%
57.4
126.0
19.8
5.4
600
23.6
289.0
87.6
45.6
6.2
>1200
Samuels and
Corn 1979b
Caste 7260/
70 ft3
- 12" from chamber/
12" from floor
- 12" from chamber/
midpoint of chamber
- 12" from chamber/
72" from floor*
- 72" from chamber/
midpoint of chamber
- Operator Sample"
- Average Peak Concentration0
46.6
41.8
411.2
55.4
48.6
135.0
103.6
400.6
1728.0
92.9
37.3
372.0
Samuels and
Corn 1979a
*Five minute area samples collected by fixed charcoal tubes.
''Twenty minute personnel sample collected by charcoal tube affixed at operator breathing zone*
cAverage of peak concentrations measured by portable Infrared gas analyser.
-------
handle and transfer such goods, and the time required in transferring
goods to an aerator or storage facility.
Table 4-7 summarizes data regarding actual worker exposures
occurring while unloading the sterilizer and transferring the treated
goods to an aeration cabinet. These data, obtained from analysis of
charcoal tube personnel monitors, indicate that workers at this hos-
pital central supply facility were exposed to ETO in the range from
approximately 20 ppm to approximately 1500 ppm each time they un-
loaded a sterilizer. Actual aggregate exposure to ETO was dependent,
to some extent, on the techniques used in transferring the treated
goods and the associated time involved in the operation. For exam-
ple, the worker in Sample 3, who was exposed to 108 ppm over approx-
imately 1 minute, used a wire basket to transfer the goods from the
sterilizer to the aerator while the worker in Sample 4, who was ex-
posed to approximately 1500 ppm over approximately 3 minutes, physi-
cally handled the goods and, at one point, cradled some items in her
arms while looking for available aerator space (Samuels 1978). Fur-
ther, the low level of exposure experienced by the operator while
unloading the 30 cubic foot sterilizer was due, in part, to the fact
that the operator transferred the goods by pulling rather than push-
ing the cart. An infrared gas analyzer located "upwind" of the cart
recorded ETO concentrations of up to 250 ppm (Samuels 1978).
4.1.4.2 0ffga8sing from Treated Goods in Storage. As noted
above, material removed from the sterilizer contains absorbed and/or
4-19
-------
TABLE 4-7
WORKER EXPOSURE TO ETO WHILE UNLOADING
CHAMBER AND TRANSFERRING GOODS TO AERATOR
Circumstances3
ETO Concentration
Sample Time
(ppm)
(minutes)
Unloading small (2 ft^) sterilizer
511
2.5
and transfer of load to small
aerator
1080
3.0
108
1.0
1490
3.0
Unloading 2 small (2 ft^) steri-
250
8.0
lizers and transfer of loads to
small aerator
895
3.0
Unloading 30 ft^ sterilizer and
18.5
3.0
transfer of load to large aerator
aThese activities were performed by individual ETO sterilizer
operators following different chamber unloading and materials
handling procedures.
SOURCE: Samuels (1978).
4-20
-------
entrapped ETO which offgasses to the surrounding atmosphere and can
serve as an extended source of ETO release to the workplace. This is
particularly applicable to facilities where treated goods are stored
in a warehouse area, particularly in situations where such areas are
not partitioned from the general workplace. One source reported
chronic ambient concentrations ranging from 5 to 40 ppm resulting
from offgassing of treated goods (Roy 1980a).*
4.1.4.3 Releases from Aeration Cabinets. Many hospital facili-
ties utilize aeration cabinets rather than open-shelf aeration rooms
to speed elution of residual ETO. If unvented or vented directly
into the room where they are located, such aeration cabinets may
serve as an additional source of ETO release and potential worker
exposure. Glaser et al. (1977) reported that almost all aeration
cabinets used in four Washington, D.C. hospitals were vented either
directly into the workplace or into the equipment area behind the
cabinet. Similarly, in a study of ETO facilities at 23 California
hospitals, 9 of the 26 (35 percent) aeration cabinets were vented
directly into the workplace and eight (31 percent) were vented into
the machinery area behind the cabinet (Daley et al. 1979). Table 4-8
presents data regarding the concentrations of ETO recorded 1 foot
above the vent of a 48 cubic foot aeration cabinet.**
*The actual concentrations will vary depending upon the amount and
type of sterilized goods as well as the size of the specific work-
place where such treated goods are stored or handled (Roy 1980a).
**In this facility the aeration cabinet is vented to an exhaust
system which removes the vented air to the outside atmosphere
(Samuels 1978).
4-21
-------
TABLE 4-8
ETO CONCENTRATIONS MEASURED AT
AERATION CABINET EXHAUST VENT3
Time
ETO Concentration
(minutes)
(ppm)
Pre-fan Stage'5
1.5 to 500
Initial Surge
>1200
1
720
2
360
3
240
5
168
15
120
25
108
30
108
aSample probe located 1 foot above exhaust vent.
Measurements taken with portable Infrared gas
analyzer.
^Monitoring conducted over 6 minute period
during pre-fan stage.
SOURCE: Corn (1980).
4-22
-------
4.1.5 Cylinder Changeover Operations
In addition to sources of ETO release in the course of normal
operation, workers may be actively exposed to ETO while replacing
drained cylinders of ETO. Because of the internal resistance in
the gas delivery system, ETO cylinders and transport lines are never
totally exhausted; some gas remains in the cylinder and in the piping
network. This ETO is released, usually directly into the breathing
zone of the worker, when the cylinder is disconnected and the gas
lines are bled. Workers may be exposed to peak ETO concentrations
ranging from 100 to 300 ppra while performing such operations (Roy
1980a).
4.2 Uncommon Exposure Sources
ETO release to the workplace may also result from non-routine
events or sources. These are generally the result of substantial
equipment malfunction and are thus likely to occur less frequently
than ETO releases from more common sources.
4.2.1 Failure of Door Locking Mechanism
An imperfect door seal due to failure of the door locking
mechanism may result in substantial ETO release during the entire
treatment cycle. Such malfunctions are more likely to occur in older
models than newer ones (Roy 1980a); however, no data were identified
to estimate the frequency of such occurrences or the extent of ETO
release.
4-23
-------
4.2.2 Maintenance or Repair Work Resulting from System
Malfunction
Maintenance and repair work, especially resulting from equipment
breakdown or system malfunction, may result in active worker exposure
to high levels of ETO. Such exposure may result from leaks, work on
pressurized gas lines, and work on chambers in which the steriliza-
tion cycle may have been aborted prior to completion of the treatment
cycle (Roy 1980c). No information is available to estimate the fre-
quency or magnitude of such exposures.
4.2.3 Release of Emergency Relief Valve
All pressure vessels are equipped with an emergency relief valve
which is designed to open before the pressure rating of the vessel
is exceeded. Unless controlled, opening of this valve would result
in the release of substantial quantities of ETO to the workplace
(Roy 1980a). No information is available to estimate the likelihood
of such an occurrence.
4.2.4 Major ETO Leak or Spill
Major ETO leaks or spills involving release of substantial quan-
tities of ETO to the workplace may result from malfunctions of the
tank, tank valve, tank overpressure safety valve, or from a ruptured
gasline (Roy 1980a). Such releases would result in significant expo-
sure to workers in the vicinity and may, in some situations, present
an explo&ive hazard. No data are available, however, to estimate the
likelihood of such occurrences.
4-24
-------
4.3 Summary
Table 4-9 summarizes information regarding the sources of
release and events which may result in worker exposure to ETO. In-
cluded are information regarding the extent, location, and duration
of such releases as well as the nature of the exposure which may
result. It should be noted that the ETO concentrations which are
reported are, in many cases, recorded at the point of release rather
than at the operator breathing zone. These may, therefore, not be
representative of levels of actual worker exposure. Many factors,
both mitigating and contributory, link ETO release to worker expo-
sure. These include the extent, duration, and frequency of release,
the location of the release relative to the worker, and the volume
and ventilation characteristics of the workplace, among others.
4-25
-------
TABLE 4-9
SUMMARY OF SOURCES AMD EVEHTS ASSOCIATED WITH POTENTIAL WORKER EXPOSURE TO ETO
4>»
I
ro
o*
Exposure Source or Event
Extent of ETO Release
Location of Release
Nature of Exposure
Comments
References
CoMon Sputf^j
Before Treatment Cycle
Leaka from gas delivery
Peak ETO concentrations
To workplace or recessed
Passive exposure.
Leaks are,in part, a
Glaser 1977;
system
ranging from 400 to
equipment area.
function of effec-
Daley et al. 1979
3000 ppm measured near
tiveness of preven-
point of release.
tive maintenance
programs.
During Treatment Cycle
Leaks fron door gasket
Peak ETO concentrations
ranging from 600 to
20,000 ppm recorded at
sterilizer door during
cycle.
To workplace
Passive exposure.
Leaks are in part, a
function of effec-
tiveness of preven-
tive maintenance
programs.
Koketsu et al. 1977;
Daley et al. 1979
I^aks from atmospheric
Peak ETO released dur-
To workplace.
Passive exposure.
Releases from some
Andersen 1978;
sterilizers
ing gas charge phase
ranging up to 750 ppm
(Castle-»Sybron Model
1500); average ETO con-
centrations around Ben
Venue Steriliser rang-
ing from 5 to 73 ppm
during cycle; average
ETO concentrations
around H. V. Andersen
sterilizers range from
2 to 5 ppm during ex-
posure phase.
atmospheric chambers
are due to equipment
design.
Hamlin 1980b;
Morgan 1980b;
Bruyer 1979a;b
Discharge to aewer drain
Peak ETO concentrations
To workplace or recessed
Vorkers in general work
Equipment areas are
Koketsu et al.1977;
up to 8000 ppm measured
equipment area at floor
area may be passively
frequently parti-
Roy 1980a;
at floor level near
level.
exposed If ETO refluxes
tioned off and main-
Ruck 1978;
drain.
into work area.
tained at negative
pressure relative to
general work area.
Weidrich 1980
Chambers vented to workplace
N.I.
To workplace.
Passive exposure.
Limited numbers of
small vacuum chambers
installed without
fixed vent lines to
atmosphere are pre-
sumed to be in
operation.
ECRI 1975
Leaka to chamber vent lines
ETO concentrations of
100 ppa recorded near
steilllzer vent
coonec tlou.
To workplace or recessed
equipment area.
Passive exposure.
Daley et al. 1977
-------
TABLE 4-9 (CONTINUED)
l
to
Exposure Source or Event
Extent of ETO Release
Location of Release
Hature of Exposure
Comments
References .
"una Sources
After Treatment Cycle
Opening chober door and
unloading treated goods
Peak ETO concentrations
up to 1000 ppm released
within 1 to 2 minutes
after opening chamber
door; concentrations
typically fall to 10
ppm or Less within
IS minutes after door
opening (measured
directly in front of
chaster door).
To workplace generally at
breathing zone level.
Workers opening the
chaaber door and
Immediately unloading
treated goods will be
exposed to peak con-
centrations; other
workers in the vicinity
may be passively ex-
posed to ETO which dis-
perses into workplace.
Data are applicable
to small and inter-
mediate sized cham-
bers typically found
in hospitals*
Releases from large
industrial chambers
and chambers which
have not been opened
Imprtlately after
cycle completion may
be higher. Workers
who manually unload
chamber or who must
enter chamber may be
exposed to ETO for
longer time periods.
Acfcert 1980a;
Com 1980;
Roy 1980a;
Samuels 1978;
Weldrich 1980
Offgiiwlng from treated
goods during transfer
ETO concentrations
ranging from 17 to
12,000 ppm recorded
directly above treated
gooda.
To workplace.
Workers transferring
goods may be actively
exposed; other workers
In the vicinity msy be
passively exposed-
Duration of exposure
typically limited to
10 minutes or less;
aggregate exposure
reduced if material
handling equipment
(carts, baskets) used
and if transfer dis-
tance la minimal.
Koketsu et al. 1977;
Roy 1980a;
Samuels 1978
Offgauing froa treated
goods in storage
Chronic ambient ETO
concentrations ranging
from 5 to 40 ppm.
To storage area.
tforkers stations in
storage areas may be
chronically exposed
to elevated ETO
concentrations•
Ambient ETO concen-
trations vary with
amount and nature
of goods in storage
and volume and ven-
tilation of storage
area.
Soy 1980a
(Invented or poorly voted
areation cabinets
Other
Peak ETO concentrations
>1200 ppm during Ini-
tial surge falling to
approximately 100 ppm
within 30 minutes
(measured 1 foot above
exhaust vent of 45 ft3
cabinet.
To workplace or recessed
equipment area.
Workers stationed in
general workplace may
be passively exposed
if ETO concentretions
accumulate.
Corn 1980
Cylinder changeover
operations
Peak ETO concentrations
ranging from 100 to
300 ppm.
To equipment area at
breathing zone.
Workers changing
cylinders may be ac-
tively exposed to ETO
remaining in ETO
cylinders and transport
lines.
Roy 1980
-------
TABLE 4-9 (CONCLUDED)
-P>
I
K)
CO
Exposure Source of Event
Extent of ETO Release
Location of Release
Nature of Exposure
Comments
References
Uncomon Sources
Failure of door locking mechanism
H.l.
To workplace.
Passive exposure.
More likely to occur
In older nodels.
Roy 1980a
Maintenance and repair work
resulting froa system aalfunction
H.I.
To workplace or recessed
equipment area.
Maintenance personnel
nay be actively ex-
posed to release fron
leaks or while working
on pressurized gas lines
or chambers.
Roy 1980a
Release of emergency relief valve
H.I.
To workplace or recessed
equipment area.
Passive exposure to
workers in area.
—
Roy 1980a
Major ETO leak or spill
H.I.
To workplace or recessed
equipment area.
Active and/or passive
exposure to workers in
area.
Roy 1980a
N.I. - Ho Intonation.
-------
5.0 AVAILABLE CONTROL MEASURES TO MITIGATE WORKER EXPOSURE TO ETO
Control measures to mitigate worker exposure to ETO Include
engineering modifications to the sterilization/fumigation equipment,
workplace design considerations, and work practices. These measures
address the control of worker exposure by:
• Preventing or minimizing ETO release into the workplace
• Removing ETO at the point of release before it can escape
into the work environment
• Diluting ETO which has escaped
• Isolating sources of release
• Isolating workers from sources of exposure
• Limiting the duration of worker exposure
In general, engineering modifications address specific exposure
sources by preventing or minimizing the release of ETO into the work-
place. Workplace design considerations primarily address passive
exposure to ETO by isolating sources of exposure and by ventilation.
Work practices are intended primarily to limit the magnitude and
duration of worker exposure.
Specific control measures currently available to reduce worker
exposure are discussed in detail below. Information indicating the
effectiveness of these control measures is presented where it is
available.
5.1 Engineering Modifications to Sterilization/Fumigation Equipment
Engineering modifications are applicable to the sterilization
equipment as well as to accessory equipment. These modifications
-------
encompass control systems to monitor leaks in the sterilization cham-
ber, improvements in the effectiveness of chamber evacuation systems,
and modifications to chamber and aerator vent systems. Manufacturers
may incorporate these modifications in the design of new equipment or
make them available as retrofit options for earlier models. In some
instances, modifications have been developed and implemented directly
by the user. The engineering modifications identified in this study
and their intended functions are summarized in Table 5-1.
5.1.1 Automatic Leak Detection Systems
Some current models of vacuum chambers incorporate leak
detection systems which monitor the vacuum or pressure levels in the
chamber prior to sterilant introduction and during the exposure phase
and either alert the operator or automatically abort the cycle in the
event of a variance in pressure. Incorporation of such monitoring
systems has been facilitated by the use of microcomputer controls in
some of the newer vacuum chambers such as those manufactured by AMSCO
(Eagle Series) and 3M (Models 400B and 202B). Manufacturers of large
industrial chambers may also incorporate such features if specified
by the customer.
Controls incorporated in AMSCO Eagle Series chambers monitor
the time required to attain the initial vacuum, the time required to
introduce the sterilant to a predetermined pressure, and the pressure
changes in the chamber during the exposure phase. If the time and
pressure changes exceed predetermined levels, thereby indicating a
5-2
-------
TABLE 5-1
SUMMARY OF CURRENTLY AVAILABLE ENGINEERING CONTROL MEASURES
Modification
Function
Automatic leak detection system
Improved chamber evacuation system
Drain venting modification
Remote controlled door opening
Chamber ventilation system
Gas line check valves
Vent pressure relief valves to
atmosphere
Vent aeration cabinets to outside
atmosphere
Monitor vacuum/pressure changes in steri-
lization chamber during cycle to detect
leaks or other malfunctions.
Remove a greater proportion of the ETO
present in the chamber and in treated
materials prior to opening the chamber
door.
Seduce the amount of ETO released at the
drain during chamber exhaust.
Permit the operator to open the chamber
door from a remote location to minimize
exposure to initial peak ETO concentrations
released initially upon door opening.
Create sufficient airflow to capture and
remove ETO released upon door opening and
prevent its diffusion into workplace.
Shorten the length of gas line requiring
bleeding during cylinder changeover thus
reducing the amount of ETO released during
this operation.
Direct ETO released in event of release of
pressure relief valve to outside atmosphere.
Direct ETO released from treated goods
during aeration to outside atmosphere.
5-3
-------
leakage or other abnormal condition,* an alarm is activated (Spoden
1980). The operator may then attempt to remedy the situation by fur-
ther tightening the door closing mechanism, may continue the cycle by
activating a reset button, or may abort the cycle.** If the situa-
tion persists, the alarm will be reactivated (Spoden 1980).
The 3M Models 40OB and 202B also incorporate leak detection
monitoring into the chamber design. If the initial vacuum level is
not attained and maintained, the cycle is automatically aborted prior
to puncture of the cartridge.*** In addition, if the chamber pres-
sure approaches atmospheric levels during the cycle, indicating air
seeping into the chamber, the vacuum pump is automatically activated
(Ackert 1980; 3M 1978).****
Similar leak detection capabilities are offered in large,
industrial, computer-controlled units such as those manufactured by
*Excessive time required for sterilant introduction may Indicate
a blocked supply line as well as a leak in the chamber or in
the sterilant delivery system. Excessive pressure losses dur-
ing exposure may indicate a leak or may be due to greater than
average absorption of the sterilant into the load being treated
(Spoden 1980).
**If the cycle is aborted, the controls automatically advance
the cycle through the evacuation phase before the door may be
opened (Spoden 1980).
***0ther possible reasons for failure to attain and maintain the
vacuum level include a blocked vacuum port, a restricted vent
line, an improperly functioning vacuum system, or insufficient
air pressure to the air venturi vacuum pump (3M 1978).
JU JU Jb
3M chambers use 100 percent ETO and operate under negative pres-
sure throughout the cycle. Therefore, any leak would result in
air flowing into the chamber (Ackert 1980).
5-4
-------
Vacudyne-Altair (Skocypec 1980). These units provide a printout of
all operating parameters, including vacuum/pressure levels, and are
capable of notifying the operator in the event that these levels
exceed expected variances.
5.1.2 Chamber Evacuation System Modifications
In the typical ETO vacuum cycle, a single post-vacuum is used to
evacuate the ETO present in the chamber. Modifications to the post-
vacuum phase of the cycle are intended to remove a greater proportion
of ETO from the chamber to minimize the amount that is released when
the chamber door is opened after completion of the cycle. Such modi-
fications are being offered by AMSCO, Castle-Sybron, and 3M either as
standard features incorporated into their current lines, as options,
or as retrofit modifications. In addition, manufacturers of large
industrial chambers can incorporate various features which are
designed to improve the effectiveness of chamber evacuation. These
features, however, are typically custom-designed to meet user spe-
cifications rather than incorporated as a standard design element.
Three approaches to improving the effectiveness of the chamber
evacuation system have been identified in the course of this study:
multiple post-vacuum, pulsating post-vacuum, and air wash. The char-
acteristics of these alternative approaches along with the chamber
models for which they are applicable are summarized in Table 5-2 and
discussed below.
5-5
-------
TABLE 5-2
SUMMARY OF AVAILABLE MODIFICATIONS TO CHAMBER EVACUATION SYSTEMS
Ln
I
o\
Modification
Description of Operation
Manufacturers and Models
Multiple Post-Vacuums
Typical evacuation process (evacuate chamber to pre-
determined vacuum level; introduce air to atmospheric
pressure) is automatically repeated for predetermined
number of times
AHSCO (Eagle Series)
Op to 15 post-vacuums included as standard feature
AHSCO (Medallion Series)
2 post-vacuums included as standard feature
Beverly Pacific
dependent upon customer specification
Vernitron-(custom chambers)
included as standard feature
Vernitron-(standard chambers)
expect to include as standard feature
Pulsating Vacuum
Vacuum operated intermittently during up to 30 minute
chamber evacuation period (vacuum pump operates for 30
seconds; air introduced for 30 seconds), with each suc-
cessive vacuum pulse creating a slightly deeper vacuum
level in the chamber.
Castle—Sybron
available as option for new chambers (other than
Model 1500) and as retrofit package for existing
installations
Air Hash
Continuous passage of air through closed chamber
Continuous Purge
Chamber evacuated to predetermined level; air introduced
into chamber while vacuum system continues to operate
thereby creating airflow through the chamber. Airflow
continues until chamber door is opened.
3M Corp. (Models 400B and 202B)
included as standard feature
3M Corp. (Models 400 and 202)
available as retrofit package
Chamber Circulation System
Modification by addition of
inlet and exhaust valves.
CirculatoT component operates after evacuation process
to draw air into the inlet valve, through the chamber,
and out the exhaust valve.
Large Industrial Chambers
chambers with recirculating systems may be
retrofitted
-------
5.1.2.1 Multiple Post-Vacuums. Multiple post-vacuums entail
the automatic repetition of the post-vacuum sequence for a predeter-
mined number of times. Each successive vacuum is designed to remove
an additional proportion of the ETO present in the chamber; the pro-
portion removed is directly related to the depth of vacuum created
in the chamber. Such evacuation systems are available on chambers
manufactured by AMSCO, Beverly Pacific, and Vernitron.
AMSCO chambers have incorporated two successive post-vacuums
as a standard feature since 1965; however, their most recently in-
troduced series (Eagle Series) permits the user to select up to 15
post-vacuums (Spoden 1980). Generally, however, the manufacturer
considers five post-vacuums to be sufficient (Spoden 1980).
Beverly Pacific, a manufacturer of vacuum chambers for indus-
trial users, also incorporates multiple post-vacuums into its cham-
ber design. The number of such vacuums is determined by the user
(Sias 1980). Chambers manufactured by Vernitron for industrial users
are currently available with multiple post-vacuums; however, their
standard-sized chambers, intended primarily for hospital use, are
typically equipped with a single post-vacuum (Kxeyling 1980).*
Limited information is available to evaluate the effectiveness
of multiple post-vacuums in reducing the quantities of ETO which
are released into the workplace upon opening the chamber door. At
*To date, only one hospital chamber has been constructed with a
multiple post-vacuum feature (Kreyling 1980).
5-7
-------
present, the only available information is based on theoretical cal-
culations of ETO concentrations present in the closed chamber at the
conclusion of several successive post-vacuums (Table 5-3). These
data, while verified by actual measurement (Gunther 1980), pertain to
an empty chamber and do not take into account the effects of offgas-
sing from treated material in the chamber (AMSCO 1979). Such offgas-
sing is expected to result in higher ETO concentrations than would be
present in an empty chamber (Young 1980).
5.1.2.2 Pulsating Post-Vacuum. Castle-Sybron has introduced
a modification to the typical post-vacuum cycle which is available
as an option in new chambers and for retrofitting into existing
chambers. This modification permits the vacuum pump to operate for
30 seconds and then permits air to enter the chamber for 30 seconds,
with each successive pulse creating a slightly deeper vacuum. This
sequence may be repeated for up to 30 minutes, Castle-Sybron recom-
mends a 15 minute post-vacuum period for typical hospital loads while
*AMSC0 is currently engaged in a research effort to determine the
extent and characteristics of ETO release under various cycle and
workplace design conditions and to develop possible solutions for
reducing the extent of exposure. As part of this effort, AMSCO
has been monitoring ETO releases after each of the successive post-
vacuums. This monitoring was initially conducted with an empty
chamber and is currently being conducted with filled chambers. In
addition, AMSCO is evaluating various modifications to their typical
multiple post-vacuum evacuation system. For example, one modifica-
tion being evaluated entails incorporation of a time delay between
the successive post-vacuums. As the research effort is currently in
process, no specific data were made available; however, AMSCO antic-
ipates completion of the project and publication of findings during
the spring of 1981 (Gunther 1980; Spoden 1980; Young 1980).
5-8
-------
TABLE 5-3
ETO CONCENTRATIONS IN CLOSED
CHAMBER AFTER SUCCESSIVE POST-VACUUMS*
Number of Post-Vacuums
ETO Concentration
(ppm)
1
26,000
2
2,600
3
260
4
26
5
2.6
aTheoretical concentrations in empty chamber
after completion of cycle and prior to open-
ing chamber door. These levels do not
account for offgassing of residual ETO from
treated products.
SOURCE: Adapted from AMSCO 1979.
5-9
-------
a longer period is recommended for material which offgasses more
rapidly (Weidrich 1980). As of July 1980, such modifications have
been made to 30 chambers (Frechette 1980).
The effectiveness of the pulsating post-vacuum in reducing the
quantity of ETO that is released to the workplace has been evaluated
independently and by the manufacturer. The results of these evalua-
tions are summarized in Table 5-4.
The data reported by Samuels and Corn (1979b) indicate that
implementation of a pulsating post-vacuum was associated with an
approximately 52 percent reduction in average ambient concentrations
of ETO for the first 5 minutes after door opening* and an approxi-
JL A
mately 86 percent reduction in operator exposure. The peak values
recorded were approximately 54 percent lower after the chamber mod-
ification.*** These findings, however, were only applicable when
the chamber door was opened immediately upon cycle completion. When
treated materials were left in the closed chamber after completion of
the cycle, ETO concentrations were found to increase due to the con-
tinued offgassing and the ambient ETO concentrations rose accordingly
when the door was opened.
*This represents the average of four fixed, 5 minute samples
collected in charcoal tubes.
**The operator sample was collected for 20 minutes after door
opening.
***Measurements were taken with a Wilks-Miran portable infrared gas
analyzer.
5-10
-------
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-------
These findings, suggesting a reduced effectiveness if the cham-
ber door is not opened immediately upon cycle completion, are not
supported by data supplied by Castle-Sybron. Their findings indicate
that peak values were reduced to negligible levels for a period of
up to 12 hours after cycle completion. After 62 hours, however, the
peak values were equivalent to those reported for a standard evacua-
tion cycle (Bruyer 1978). Castle-Sybron suggested that the discrep-
ancy between their findings and those reported by Samuels and Corn
(1979b) may have been due to differences in the nature of the test
loads (Weidrich 1980).
A third evaluation of this modification has been conducted at
the Walter Reed Army Medical Center. The area in front of the cham-
ber was monitored using a Wilks-Miran portable infrared gas analyzer
at a point 6 inches from the door and at shoulder height. Immedi-
ately upon door opening, peak ETO concentrations were found to be
18 ppm. Within seven minutes after door opening these concentrations
dropped to 15 ppm and subsequently to 3 ppm within 15 minutes after
door opening (McLeod 1980). No comparable data are available for ETO
concentrations prior to implementation of the modification.
5.1.2.3 Air Wash. A third approach to improving the effective-
ness of the chamber evacuation system entails permitting air to con-
tinuously flow through the chamber for a specified time period. This
may be accomplished by operating the vacuum pump while permitting air
to enter the chamber or by the addition of diversionary valving to
5-12
-------
the chamber recirculation system. The latter method is only appli-
cable to large industrial chambers whose design includes such a
system.*
Continuous Purge. The 3M Company has incorporated a continuous
purge evacuation system in all Model 400B and 202B chambers and in
some Model 400 and 202 chambers.** This modification is also avail-
able for retrofitting into Model 400 and 202 chambers which were
manufactured prior to the development of this feature.
The continuous purge evacuation system, otherwise referred to as
an air wash or air flush, entails the continuous passage of filtered
air through the chamber. At the conclusion of the exposure phase, a
vacuum of approximately 25 inches Hg is created. When this vacuum
level is reached, a valve is opened to admit filtered air into the
chamber while the vacuum system continues to operate. During the
purge phase, which continues for a minimum of 15 minutes, a shallow
vacuum is maintained within the chamber. At the conclusion of the
The primary function of the recirculation system is to prevent
stratification of the sterilant/air mixture during exposure and
to facilitate homogeneous temperatures in the chamber.
**Models 400B and 202B were introduced in late 1978, Model 400
in 1969, and Model 202 in 1974. Of the total production of Model
400 units, only the last of the nine lots manufactured incorpo-
rated the continuous purge feature. Approximately one-third of
the production of Model 202 chambers incorporated this feature
(Ackert 1980).
***Retrofit packages are not available for Models 100 and 200 which
were sold prior to 1974. Rather, 3M offers a trade-in allowance
towards purchase of a new 3M chamber (Ackert 1980; Mack 1980).
5-13
-------
time period, a buzzer is sounded to notify the operator that the
cycle is completed. If the chamber door is not opened at that time,
the purge will continue until the operator presses a designated
switch and unlocks the door (3M 1978). This feature is designed
to prevent accumulation of ETO in the chamber due to offgassing from
treated materials (Ackert 1980).
The continuous purge evacuation system has been further modified
in Models 400B and 202B by heating the air which is purged through
the chamber. The elevated temperature facilitates offgassing and, in
effect, converts the sterilization chamber into an aeration cabinet
(Ackert 1980; Samuels and Corn 1980).*
A 3M Model 400B equipped with the continuous purge feature was
evaluated by Samuels and Corn (1980) to determine the amount of ETO
released into the workplace. This evaluation did not compare ETO
concentrations prior to and after implementation of the modification
as the continuous purge feature was an integral part of the chamber
design. Instead, it compared the peak ETO concentrations recorded
for two test cells: chamber door opened immediately upon cycle com-
pletion and chamber door opened after 1 hour time delay.
*3M is currently developing a chamber which would be used both for
sterilization and aeration. This would be accomplished by modifica-
tions which would enable the purge to continue for a sufficient time
period to thoroughly aerate the treated goods. This type of equip-
ment would eliminate the opportunity for worker exposure occurring
during chamber unloading and transfer of treated goods, however,
it would also limit the volume of goods that could be potentially
treated (Ackert 1980).
5-14
-------
Data summarized in Table 5-5 indicate that the continuous purge
feature was associated with the release of negligible concentrations
of ETO to the workplace. Average peak concentrations for both test
cells were approximately 6 ppm, and 20 minute time weighted averages
were calculated to be less than 1 ppm. Analysis of these samples,
both fixed and personnel, indicated undetectable ETO concentrations
(Samuels and Corn 1980).*
While the continuous purge feature is currently commercially
available only for specific 3M models, one source reported the suc-
cessful in-house modification of a number of chambers of various
sizes produced by different manufacturers. The chambers, ranging
from tabletop to 70 cubic foot units and manufactured by AMSCO and
Castle-Sybron, were modified by company technicians to incorporate
a 30 minute continuous purge evacuation cycle. The modification was
found to be "very effective" in reducing the amount of ETO released
when the chamber door is opened. It was further found to have
reduced the amount of ETO subsequently released from offgassing by
approximately 80 percent (Roy 1980a). More specific data were not
made available.**
The lower detectable limits for this method were calculated to be
8 ppm for the 5 minute fixed sample and 2 ppm for the 20 minute
operator sample (Samuels and Corn 1980).
**Prior to implementation of any modifications, peak concentrations
measured in the breathing zone were reported to exceed 100 to 200
ppm upon door opening (Boy 1980a).
5-15
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TABLE 5-5
EFFECTIVENESS OF CONTINUOUS PURGE EVACUATION SYSTEM
IN REDUCING WORKER EXPOSURE TO ETO
ETO Concentrations
(ppm)a'b
Measurement
Criteria
Door Opened Immediately
After Cycle Completion
One Hour Time Delay
in Door Opening
Average Peak Concentrationc
6.5
6.3
5 Minute TWA
2.9
3.1
10 Minute TWA
1.5
1.5
20 Minute TWA
0.7
0.8
Evaluation conducted using Wilks-Miran portable infrared gas analyzer
positioned 12 inches from the chamber and at the chamber midpoint and
reading for 20 minutes after door opening.
^Charcoal tubes were also used to collect samples at four fixed locations
and as a personnel sampler. Analysis of the samples indicated undetectable
levels of absorbed ETO. The lower detectable levels for this method are
8 ppm for fixed samples and 2 ppm for operator breathing zone samples
(Samuels and Corn 1980).
cAverage of duplicate tests.
SOURCE: Samuels and Corn 1980.
5-16
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Modification to Chamber Recirculating System. Some large indus-
trial chambers include a recirculating system to prevent stratifica-
tion of the sterilant mixture and to enhance temperature uniformity
during the exposure phase. This recirculating system can be modified
by the incorporation of three valves: one in the recirculating line,
an inlet valve, and an exhaust valve. During the exposure phase the
latter two valves remain closed while the former one Is opened.
After normal evacuation, the inlet and exhaust valves automatically
open and admit air into the chamber. The air is drawn across the
chamber and exits via a discharge line directed outside the building
(Markinson 1980b).* No data were available regarding the ETO con-
centrations that would be released to the workplace after implemen-
tation of this modification.
5.1.3 Liquid/Gas Separator
Addition of a liquid/gas separator into the venting systems of
chambers which exhaust to the sewer drain is intended to reduce the
amount of ETO which is released at the drain during the exhaust phase
of the sterilization cycle.
This modification is available from Castle-Sybron for retrofit-
ting into existing installations and as an optional feature in new
*The circulators which are used to create the airflow through the
chamber typically have limited air handling capacity. As such,
an extended time period would be necessary to effectively flush
ETO from the chamber (Markinson 1980b). No estimates of the time
period required were made available.
5-17
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units.* The separator is installed in the exhaust line of the
sterilizer beyond the vacuum pump. The water/gas mixture enters the
separator tangentially thus creating a swirling action which sepa-
rates the entrained gas from the water. The water is then directed
downward to the sewer and the gas is directed to the atmosphere via a
vent line (Castle-Sybron 1980a).
The liquid/gas separator has been included as a standard feature
in many large industrial chambers (Markinson 1980b; Sias 1980).
These separators are generally not connected to an atmospheric vent
line but are primarily intended to control the flow rate of the
water/gas mixture to prevent excessive splashing at the drain. Such
installations can be readily modified by the addition of a vent line
to direct the separated gas to the atmosphere (Markinson 1980b).
One estimate indicates that, in the absence of the liquid/gas
separator, approximately 95 percent of the initial sterilant charge
is directed towards the sewer drain while approximately 5 percent
is retained within the treated material and packaging as adsorbed or
entrapped ETO. Modification of the exhaust system by the addition
of a liquid/gas separator was estimated to divert 85 percent of the
initial ETO charge to the atmosphere with 10 percent retained in the
While these units are being marketed for Castle-Sybron chambers,
they are compatible with chambers from other manufacturers (Roy
1980b; Weidrich 1980).
5-18
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water (Markinson 1980b). Some of the entrained gas may be released
A
to the workplace at the exhaust line terminus.
Castle-Sybron (1980a) reported that after installation of the
liquid/gas separator, ETO concentrations at the drain were approxi-
mately 50 ppm.** Another source reported that ETO concentrations
were reduced by approximately 75 percent (from approximately 120 ppm
to approximately 30 ppm) after installation of a liquid/gas separator
on a 70 cubic foot chamber (Roy 1980a).
5.1.4 Remote-Control Door Opening
Beverly Pacific, a manufacturer of large industrial chambers,
has designed a unit which incorporates a remote-controlled, hydrauli-
cally operated door.*** At the conclusion of the cycle, the door
*The release of some quantities of ETO at the drain level after
installation of a liquid/gas separator has been addressed by one
contract sterilizer facility identified in the course of this
study. At this facility, the liquid effluent, rather than being
directed to the sewer, is recirculated within a closed system.
This system, which entails pumping the water to a cooling tower
located on the building roof prior to reuse, avoids the air gap
requirement and thus the opportunity for release of entrained
ETO into the workplace. This design was primarily intended to
address potential water pollution regulations related to effluent
discharge rather than to control ETO release to the workplace
(Skocypec 1980). Other facilities have addressed the possible
reflux problem by loosely enclosing the drain in a funnel (see
Appendix C).
**0ther tests conducted by Castle-Sybron have measured ETO con-
centrations 1 foot above the drain during the evacuation phase.
The peak concentrations recorded in two test runs were 10 ppm and
not detectable, respectively (Bruyer 1978). The results of these
evaluations, however, may not be typical of actual use conditions
(Weidrich 1980).
***0ne such chamber has been constructed to meet the design specifi-
cations of an industrial ETO user (Sias 1980).
5-19
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is partially opened and a diversionary fan is operated for a period
sufficient to disperse the ETO present in the chamber. The door is
then fully opened automatically and the operator enters the area to
unload the chamber. By permitting the operator to control the
chamber door from a remote location, this feature prevents exposure
to the peak levels of ETO release that occur shortly after the
chamber door is opened (Sias 1980). No data are available regarding
levels of worker exposure associated with this modification.
5.1.5 Chamber Ventilation Systems
Chamber ventilation systems are designed to operate after the
chamber door is opened in order to capture and divert ETO before it
can escape into the general workplace. Such systems may operate for
a sufficient time period after the chamber door is opened to capture
the initial ETO plume or may continue to operate throughout the un-
loading operation.
Chamber ventilation systems for large industrial chambers uti-
lize differential pressure to create an airflow from the workplace
into the chamber. Ventilation systems for smaller chambers utilize
local exhaust hoods mounted near the sterilizer door to capture and
remove ETO being released.
5.1.5.1 Differential Pressure Chamber Ventilation Systems.
Differential pressure chamber ventilation systems are incorporated
into large industrial chambers and operate when the chamber door is
opened at the conclusion of the cycle. These modifications create a
5-20
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negative pressure within the chamber. Air from the workplace enter-
ing the chamber to equalize pressure creates an airflow away from the
operator and removes a portion of the ETO remaining in the chamber by
venting it through an exhaust port in the chamber.
These systems may continue in operation during the unloading
process thereby facilitating the continuous removal of ETO from the
chamber. This is particularly applicable to chamber designs which
require the operator to enter the chamber in order to retrieve the
treated goods.
Three variations of differential pressure ventilation systems
have been identified in the course of this study. Beverly Pacific,
a manufacturer of large industrial chambers, reported modification
of some units by the addition of diversionary valving to the chamber
recirculating system. At the conclusion of the cycle the chamber
door is partially opened and the recirculating system activated. The
blower component of the recirculating system creates a pressure dif-
ferential in the chamber relative to that of the workplace thereby
forcing air to flow into the chamber (Sias 1980).
Alternatively, the chamber vacuum system can be utilized to
create the same effect. This modification, developed and currently
marketed by Environmental Tectonics Corporation, Incorporates a
microswitch which automatically activates the vacuum system when
the chancer door is opened. The modification is relatively simple
to implement and may be incorporated in chambers with either
5-21
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automatically or manually operated doors (D'Aquila 1980). No data
were available regarding the effectiveness of these modifications.
A third variation has been designed by Travenol Laboratories and
built by Vacudyne-Altair. This system is being made available as an
optional feature in new chambers and can be retrofitted into exist-
ing installations (Markinson 1980a).*
This system entails construction of a large opening on the roof
or rear wall of the chamber. The opening is fitted with a butterfly
valve and valve actuator and is connected by ducting to a fan mounted
on the roof of the building. A microswitch mounted on the chamber
door automatically opens the valve and activates the exhaust fan when
the chamber door is opened at the conclusion of the cycle. The sys-
tem is designed to create a sufficient velocity across the chamber
cross-section to assure that little or no ETO is released from the
chamber into the workplace and that the operator unloading the ster-
ilizer has sufficient airflow over him to minimize his exposure to
ETO (Markinson 1980b). it has been reported that Implementation of
this feature would reduce 8 hour time weighted average exposure to
below 10 ppm (Markinson 1980a).
5.1.5.2 Local Exhaust Hoods. Local exhaust hoods are designed
to capture a contaminant at or near its release source and prevent
Approximately 98 percent of new chambers constructed by Vacudyne-
Altair have incorporated this modification (Markinson 1980a) and
approximately six retrofit installations have been made (Skocypec
1980).
5-22
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its dispersion throughout the workplace. When mounted on the chamber
near the door opening, the hood serves to capture the initial plume
of ETO that is released when the door is opened. If operated contin-
uously, the hood also captures and removes ETO released due to door
gasket failures or other leaks (Roy 1980a).
Local exhaust hoods are available from Castle-Sybron and H.W.
Andersen and will shortly be available from 3M. In addition, at
least one industrial ETO user identified in the course of this study
has designed and custom-fabricated local exhaust hoods for a number
of different model chambers.
The 3M Company has designed and is currently evaluating local
exhaust hoods to be made available as accessories for Models 400 and
200. These hoods, which are expected to be commercially available in
late 1980, are designed to be mounted on the top of the chambers and
connected to the building ventilation system. The hood is equipped
with a door latch to hold the door in a partially opened position
and is intended to be operated only at the conclusion of the cycle
(Ackert 1980).
Evaluations of the effectiveness of this modification have been
performed by the manufacturer and an Independent source. While com-
plete data were not available from 3M, it was reported that use of
the local exhaust hood resulted in peak airborne ETO concentrations
5-23
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of approximately 1 ppm. Peak airborne concentrations without the
hood were reported to range from 100 to 1000 ppm (Ackert 1980).
An independent evaluation of a 3M Model 200 chamber equipped
with a similar, though side-mounted, hood was conducted by Samuels
and Corn (1979a). Their findings, presented in Table 5-6, indicate
that such a modification was effective in reducing worker exposure
levels and ambient concentrations of ETO. In the absence of the
local exhaust, analysis of the 20 minute operator samples indicated
aggregate exposure levels of approximately 5 to 6 ppm. These levels
were reduced by approximately 52 to 63 percent with use of the local
exhaust hood.
Use of the local exhaust hood was also associated with a sub-
stantial reduction in peak ETO concentrations. Without the modifica-
tion, these levels were reported to range from 600 to over 1200 ppm.
The latter values were recorded after 1 hour time delay in opening
the chamber following cycle completion and reflect the accumulation
of offgassed ETO from treated materials. Peak ETO concentrations
recorded when the local exhaust was used were approximately 67 ppm
when the door was opened immediately upon cycle completion and 62 ppm
when there was a 1 hour delay in opening the chamber. It was also
reported that when the local exhaust was used, the peak values were
*Testing was conducted in a 1000 cubic foot room with 10 air changes
per hour. Monitoring was conducted with an HNu photoionization
instrument with the sample probe located 1 foot from the chamber
door at the breathing zone level (Ackert 1980).
5-24
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TABLE 5-6
EFFECTIVENESS OF A LOCAL EXHAUST HOOD IN REDUCING WORKER EXPOSURE TO ETO8
Ul
J
N>
Ul
ETO Concentrations (ppn)
Without Modification
With Modification
Method and
Location of Saapllng
Measurement
Door Opened Twat fi lately
Upon Cycle Coapletlon
One Hour Time Delay
In Door Opening
Door Opened Inaediately
Upon Cycle Coapletlon
One Hour Time Delay
In Door Opening
Charcoal Tube Saaples
12" froa clumber/
12" fro* floor
5 minute TWA
28.7
23.6
not detectable
not detectable
12" froa chaaber/
aldpoint of chaaber
5 alnute TWA
57.4
289.0
not detectable
not detectable
12" froa chaaber/
72" froa floor
S alnute TWA
126.0
87.6
not detectable
not detectable
72" froa chaaber/
aldpoint of chaaber
5 alnute TWA
19.8
45.6
not detectable
not detectable
Operator Saaple'1
20 alnute TWA
5.4
6.2
2
<2
Infrared Gas Analysis
12" froa chaaber/
aldpoint of chaaber
Average peak c
concentration
600
>1200
66.7
62.3
IS alnute TWA
24.6
55.3
6.5
1.3
20 alnute TWA
18.4
41.5
8.3
2.6
'Evaluation conducted for a 3K Model 200 equipped with side Mounted exhaust hood connected to an existing exhaust duct. The vacuum
for the exhaust was created by using coapreased air directed over a aaall orifice In the hood (Ssauels and Corn 1979b).
^Operator saaple obtained froa charcoal tube attached to lapel. Operator vonitored While following standard protocol, as follows:
open sterilizer door, return to work station at least 10 feet away tram sterilizer for a prescribed tine period, return to steri-
lizer to rouve load and position In aeration cabinet, return to work station until completion of 20 minute saaple period.
c
Average of. duplicate tests.
-------
recorded approximately 10 to 14 minutes after the door was opened
rather than within approximately 80 seconds as was found when no
local exhaust was used. Based upon these findings, it was suggested
that chambers equipped with local exhaust hoods be unloaded within 5
minutes of door opening to avoid operator exposure to the peak con-
centrations (Samuels and Corn 1979a).
A similar local exhaust is available as a standard feature for
Castle 1500 chambers* and may be retrofitted onto existing instal-
lations (Weidrich 1980). The hood, which is mounted on top of the
chamber, is designed to be connected to a negative pressure vent
supplied by the user. It operates continuously and is intended to
remove ET0 escaping when the chamber door is opened or from leaks
(Castle-Sybron 1980b).
ETO concentrations were measured 1 foot in front of a Castle
1500 chamber to evaluate the effectiveness of the local exhaust hood
in removing ETO.** Baseline levels were established with and with-
out operation of the room vent fan. Subsequent readings were taken
after the local exhaust hood was connected to the vent duct.
When the chamber was operated with the room fan off, measure-
ments indicated that ETO gas was being released for approximately
*This has been available since 1980.
it it
The chamber was located in a room equipped with a negative pres-
sure exhaust duct. A Wilks-Miran portable infrared gas analyzer
was used to measure ambient ETO concentrations.
5-26
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13 minutes during the sterilant introduction phase* and again for
approximately 4 minutes after the chamber door was opened at the con-
clusion of the cycle. The peak concentrations recorded during both
excursions were approximately 900 ppm. With the room fan operating,
the initial release during the gas introduction phase was reduced to
6.3 minutes in duration with peak concentrations recorded at less
than 100 ppm. A peak concentration of approximately 600 ppm was
recorded upon door opening; this excursion lasted less than 1 minute.
Measurements taken when the vent hood was connected to the exhaust
vent indicated no detectable concentrations of ET0 either during gas
introduction or upon door opening (Bruyer 1979b).
A third type of commercially available ventilation hood is being
marketed by H.W. Andersen Products and is designed to be used with
the AN-74 sterilizer.** It consists of a rectangular sleeve into
which the sterilizer is placed, a centrifugal blower, and a 12 foot
flexible hose. The hose is intended to be vented through a window
or wall to the outside atmosphere (H.W, Andersen Products undated b).
This system is designed to operate continuously throughout the ster-
ilization process to capture ETO which diffuses from the nongasketed
sterilizer.
*During the gas Introduction phase, ETO escapes from the chamber
along with the displaced air (See Section 2.1.2).
**This ventilation system may also be used with Anprolene Steril-
izers AN-70 and AN-72.
5-27
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Tests conducted by H.W. Andersen indicate that average ETO con-
centrations in the vicinity of the sterilizer were reduced over the
treatment cycle from approximately 5 ppm to less than 2 ppm when the
ventilation hood was used (Hamlin 1980b).
One industrial facility identified in the course of this study
has designed and installed local exhaust hoods on all their steril-
izers.* The hoods included top-mounted canopy hoods, side draft,
and bottom draft slot hoods. The top-mounted canopy hood was con-
sidered to be the preferable design;** however, other configurations
were necessary to accommodate various sterilizer designs (Roy 1980a).
The standard design of the canopy hood specified that the hood
be mounted as close to the door opening as possible. A transparent
frontpiece was installed to permit viewing of gauges and dials which
are usually located above the door and a side baffle was located on
the side opposite the door hinge to aid in channeling air into the
canopy (Roy 1980a). Specific data were not available to indicate the
exposure reduction attained with use of these local exhaust hoods.
In addition to the ventilation hoods mounted on the sterilization
cabinets, this facility has designed and installed flanged hoods
with flexible ducting in the equipment area behind the sterilizers.
These hoods are intended to be used during routine replacement of
emptied sterilant cylinders and in the event of a tank leak. The
flexible ducting also permits repositioning of the hood so that it
may be used during emergency maintenance operations (Roy 1980a).
The canopy model was considered preferable because it has a lower
hood static pressure than a high velocity slot hood and therefore
required a lower airflow to capture ETO (Roy 1980a).
5-28
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5.1.6 Other Engineering Modifications
In addition to the engineering controls discussed above, other
measures have been reported which serve to control ETO release to
the workplace. These are relatively simple and can be implemented
by company personnel.
5.1.6.1 Check Valves Installed in ETO Supply Line. One-way
check valves can be Installed in the gas supply lines leading from
the cylinders to the sterilizer. These valves, Installed close to
the tank connection, serve to shorten the length of line which oust
be bled when the emptied cylinders are replaced. This minor modifica-
tion serves to reduce the amount of ETO to which the worker perform-
ing this operation is exposed. It is recommended that these valves
be replaced semiannually (Roy 1980a).
5.1.6.2 Venting Chamber Pressure Relief Valve. A second modi-
fication entails connection of a vent line to the pressure relief
valve on the chamber. This valve is designed to open automatically
if the pressure level in the chamber exceeds specified design cri-
teria. Should this occur during the exposure phase, ETO present in
the chamber would be released into the workplace. Connection of a
vent line serves to divert such released ETO to the atmosphere.
5.1.6.3 Aeration Cabinet Venting. Aeration cabinets are most
typically used in hospitals to facilitate elution of ETO from treated
materials and thus permit more rapid turnover of ETO sterilized
5-29
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goods. Such aeration cabinets may be sources of exposure if they are
unvented or vented into the workplace.
Unvented aeration cabinets have been manufactured by
Castle-Sybron (Model 1550)* and by 311. The latter had manufactured
such cabinets until 1978. Since that date, all 3M aeration cabinets
have been manufactured with vent connections (Ackert 1980).
311 currently provides a modification which enables the previ-
ously unvented aeration cabinets to be vented to the atmosphere.
This modification entails changing such units from positive pressure
to negative pressure cabinets and installing an exhaust port. Ap-
proximately 3 percent of the outstanding unvented cabinets have been
modified to date (Ackert 1980).
5.2 Workplace Design Modifications
Modifications to the workplace design include provision of ade-
quate ventilation and dilution volume, isolation of exposure sources,
proper location of work stations, and traffic control. These control
measures are primarily directed towards minimizing airborne concen-
trations in the work area and limiting the number of workers who may
be exposed to ETO.
5.2.1 Ventilation
5*2.1.1 General Area Ventilation. General area ventilation re-
fers to the flushing of an entire building with large volumes of air.
ft
No modification is currently available for Castle 1550 aerators.
Rather, the manufacturer suggests they be placed in a well venti-
lated room (Castle-Sybron 1979).
5-30
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Such ventilation systems prevent the buildup of contaminants by dilu-
tion. They are most applicable as control measures in situations
where the quantity of contaminant generated is not excessive, the
workers are generally located at a distance from the exposure source,
the toxicity of the contaminant is low, and the rate of generation is
relatively uniform (Mutchler 1973b).
In areas containing sterilization/fumigation equipment or
treated goods in storage, general area ventilation dilutes ETO which
is released into the general workplace and eventually exhausts that
ETO. The effectiveness of dilution ventilation is dependent upon
the quantity of ETO released, the rate of release, the volume of the
workplace, and the rate of air circulation.*
The Association for the Advancement of Medical Instrumentation
(AAMI) recommends a minimum of 10 air exchanges per hour** for areas
in health care facilities housing ETO sterilizers or aerators. They
further recommend use of a dedicated system*** to minimize oppor-
tunities for recirculation of ETO laden air to other areas in the
building (AAMI 1980).
ft
Ventilation engineers generally prefer to express ventilation
requirements in terms of cubic feet per minute (cfm) or some
other absolute unit of airflow rather than in terms of air change
(Mutchler 1973b).
**This represents a modification of a previous recommendation
which specified a minimum of 6 air exchanges per hour.
***A dedicated exhaust system is designed to remove air and air
contaminants from a single site (whether a specific area, room,
or piece of equipment).
5-31
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Samuels acid Eastin (1980) have evaluated the effectiveness of
general area ventilation in reducing ambient concentrations of ETO.
Their findings indicate an inverse relationship between the number of
air exchanges per hour and ambient ETO concentrations and generally
support the AAMI recommendations.
Their test protocol entailed measurement of ambient air con-
centrations in a 1000 cubic foot room at 5 minute intervals after a
sterilizer door was opened. The initial ambient concentration gener-
ated by each load was 25 ppm. Measurements were taken with 0, 5, 10,
15, and 20 air exchanges per hour, respectively.
In the absence of any air circulation (0 air exchanges per
hour), ETO ambient concentrations 15 minutes after the chamber was
opened were reported to be approximately 50 ppm, indicating the ac-
cumulation of ETO in the workplace. With 5 air exchanges per hour,
the ambient ETO concentrations were reduced to approximately 22 ppm.
These levels were found to decrease in a linear fashion when air
exchange rates where increased; levels of approximately 11, 7, and
5 ppm were associated with airflows of 10, 15 and 20 exchanges per
hour, respectively.*
5.2.1.2 Local Exhaust Ventilation. Local exhaust ventilation
systems are designed to capture and remove an airborne contaminant at
or near its source before it is diffused into the work environment.
*Concentrations of ETO reported here are extrapolated from a
graphic presentation of the data and, as such, are approximations.
5-32
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Local ventilation is the preferred approach for controlling atmo-
spheric concentrations of airborne materials that present potential
health hazards in the workplace (Mutchler 1973a; Roy 1980b; Samuels
1980).
A local exhaust system consists of a network of branch ducts,
each directed to a specific exposure source. The branch ducts are,
in turn, connected to a main duct which terminates in an exhaust
stack to the atmosphere. A fan mounted on the roof is used to create
the required airflow to effectively capture the contaminant (George
D. Clayton and Associates 1973; Mutchler 1973a).
The ducting should terminate as close as possible to the source
of release. In some cases, hoods or other enclosures may be used to
facilitate capture of the released ETO (See Section 5.1.5.2).
Local exhaust ventilation has been suggested for the following
locations in the sterilization facility: near the sterilizer door,
Various conflicting recommendations are offered regarding the
optimum location of the duct outlet relative to the sterilizer door.
One source recommends locating the duct outlet, faced with a grille,
directly underneath the sterilizer door (for wall mounted units), or
in the floor area below pit mounted chambers. In situations where
this design is infeasible, a vertical duct located opposite the door
hinge and terminating 4 inches from the floor is recommended*
Locating the duct outlet above the sterilizer door is considered
to be the least desirable alternative for the following reasons!
(1) ETO, particularly in mixtures with Freon® is heavier than air
and tends to settle at the floor level; (2) duct outlets located
above sterilizers must be designed to handle a greater volume of
air; and (3) duct openings located near the floor level will direct
airflow away from the operator breathing zone (Nusbaum 1980a). In
contrast, other sources have found that ETO vapors, while heavier
than air, are carried upward by the warm air from the sterilizer
chamber (Samuels and Corn 1979b). Ducts located below or alongside
the door opening must be equipped with a greater airflow in order to
overcome the rising plume of ETO laden air (Roy 1980a).
5-33
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in the sterilizer equipment area, near the sterilizer drain vent,
near tank connections to the sterilizer, and in cylinder storage
areas (AAMI 1980; Nusbaum 1980a). In facilities where an aeration
cabinet is either unvented or vented into the workplace, a separate
branch duct with a hood or a large duct 4 inches away from the aera-
tor vent outlet can be incorporated into the system (Nusbaum 1980a).
In addition, a local exhaust duct may be located near work-stations
where treated goods are inspected or samples taken for subsequent
sterility testing (Nusbaum 1980a),
The specific design of a local exhaust system is largely depen-
dent on the architectural features of the individual facility. In
some instances, due to excessive distance between the sterilization
area and the building exterior, local exhaust systems may be diffi-
cult to implement, in such cases it may be possible to modify exist-
ing ventilation system by extending ductwork from existing ceiling
exhausts (Nusbaum 1980a).
5*2.2 Isolation
Specific aspects of the sterilization/fumigation process, or
the entire process itself, may be considered a source of potential
exposure. Workers may be Isolated from such sources by physical
barriers, such as partitions, or by distance.
5.2*2.1 Partitions. Partitions may be erected around specific
exposure sources to minimize the quantity of ETO which may escape
into the general work area. Areas which are particularly suitable
5-34
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for enclosure include the machinery area at the rear of the chamber
or aerator, the drain vent area, the cylinder connection area, and
the cylinder storage area. In addition, storage areas housing
treated goods should be partitioned from the general work area (AAMI
1980). In addition to isolating specific aspects of the ETO facil-
ity, the entire facility can be partitioned off from other work areas
and access limited to authorized personnel.
5.2.2.2 Location of Equipment and Work Station. ETO steril-
izers and aerators should be located to minimize worker exposure.
More specifically, it is recommended that employee work-stations,
desks, washing areas, and lounge areas should not be located in the
immediate vicinity of the equipment (AAMI 1980). In addition, per-
sonnel not directly involved in the sterilization process should be
routed around or away from all sterilization and aeration equipment.
This may be accomplished by using signs or posters, tape lines around
equipment areas, or temporary partitions (AAMI 1980).
In some cases, it is further recommended that consideration
should be given to relocation of equipment which cannot be effec-
tively partitioned or otherwise Isolated, such as equipment located
in hallways or heavily trafficked areas.
*
5.3 Work Practices
Work practices, as they apply to operator training, equipment
operation, material handling techniques, and equipment maintenance
5-35
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may reduce worker exposure to ETO. In addition, use of protective
clothing* and respiratory equipment may be applicable.
5.3.1 Operator Training
AAMI (1980) recommendations for safe use of ETO include provi-
sions for complete training for and supervision of personnel respon-
sible for operating ETO equipment. Such training should cover all
aspects of the treatment process, including safety factors, steri-
lizer operating instructions, and hazards. AAMI also recommends that
a training program should be conducted by the manufacturer before a
sterilizer is put into service. Subsequent training should be regu-
larly provided on an in-service (in-house) basis for all operators.
5.3.2 Equipment Operation Procedures
Several specific work practices are recommended to reduce worker
exposure while unloading the chamber. These include:
• The sterilizer door must be opened as soon as possible after
completion of the cycle to prevent the build-up of ETO in
the chamber due to desorption from treated goods (AAMI 1980;
Samuels and Corn 1979b). This may require rescheduling to
avoid completion of cycles during periods when the facility
is not staffed (Samuels and Corn 1979b).
• The chamber door should be partially opened (approximately
6 inches) and the operator and any other personnel in close
proximity should leave the immediate area for a minimum of
15 minutes. This waiting period allows most of the
*Use of protective gloves has been recommended in situations where
workers come into direct contact with freshly treated goods (AAMI
1980); however, other sources consider such protective clothing
to be Ineffective due to the permeability of many materials to ETO
(Samuels 1980).
**Nusbaum (1980b) recommends that after the initial 15 minute wait-
ing period, the operator should return to open the door fully and
again leave the immediate vicinity of the chamber for an additional
15 minute period.
5-36
-------
unevacuated ETO in the chamber to dissipate into the work-
place atmosphere and be diluted or removed by ventilation.
In cases where local exhaust ventilation is used, the time
period may be shortened (AAMI 1980).
• Chambers equipped with a purge cycle should be unloaded im-
mediately upon opening the chamber door, since it is at this
point that ETO concentrations in the chamber are at the low-
est levels (AAMI 1980; Samuels and Corn 1980).
5.3.3 Material Handling Procedures
ETO exposure to workers handling treated goods as well as to
other workers in the vicinity can be reduced by the rapid and effec-
tive transfer of goods from the sterilizer to the aeration chamber
or storage facility. To facilitate this, the aeration or storage
facilities should be located in close proximity to the sterilization
chamber(s). Specific recommendations for transferring treated goods
include:
• Treated items should be transferred to aeration or storage
facilities without delay. The aeration capacity must meet
or exceed the processing requirements of the facility (AAMI
1980).
• Personnel should avoid handling of treated goods. If hand-
ling is necessary,* protective gloves should be worn (AAMI
1980).
• Material handling equipment (i.e., baskets, rolling carts)
should be used to speed the transfer process. Materials
should remain in the baskets or on the carts during aera-
tion (AAMI 1980). Hand trucks, fork lift trucks, or other
material-handling equipment may be applicable for removing
large loads of treated material at industrial facilities.
it
Handling of treated goods may be necessary during product inspec-
tion and removal of indicator test strips or samples for laboratory
testing.
5-37
-------
• Carts should be pulled rather than pushed to direct airflow
away from the operator (AAMI 1980; Nusbaum 1980b).
5.3.4 Equipment Maintenance
A regularly scheduled preventive maintenance program is intended
to minimize equipment down-time and to identify and remedy sources of
possible ETO release. Such a program would include routine replace-
ment of high wear items such as door gaskets to eliminate the possi-
bility of worker exposure due to leaks from the chamber door seal.
In addition, other potential leak sites, such as valves, fittings,
and connections, should be tested for evidence of leakage. A halide
leak detector or soap bubble solution can be used for such routine
leak testing (AAMI 1980; 3M 1979; Weidrich 1978).
5.3.5 Personal Protective Equipment
Use of personal protective equipment exemplifies the principle
of isolating workers from their environment. Such equipment includes
protective clothing, such as gloves, goggles, and coveralls, and res-
Jb Jt
piratory devices.
*Halide leak detectors are essentially propane torches used to
detect the presence of Freon®. These detectors are not appLicable
for facilities using either 100 percent ETO or a carbon dioxide
gas mixture.
^ JL
A soap and water solution is applied to potential points of
leakage. The appearance of bubbles is evidence of a leak.
JL JL JL
In general, personal protective devices are intended to be used
only when engineering controls cannot be used or made adequate.
They are recommended for short term exposures or as a second
line of defense against inadvertent or unexpected conditions
(Schulte 1973).
5-38
-------
Protective clothing is recommended for use in situations where
exposure to liquid ETO is likely. Such situations include cylinder
changeover, emergency repair work to a chamber, and clean-up of ETO
tank spills. In such cases, it has been recommended that protective
gloves, goggles, and aprons be used (3M 1979; Roy 1980a).
It has also been recommended that operators wear gloves in
situations where they are required to directly handle treated goods
(AAMI 1980).
Use of respiratory equipment is not generally recommended for
protection against routine exposure situations; however, some indus-
trial ETO users have implemented policies which require all workers
entering an ETO sterilization area to wear air-line respirators
(Abrahams 1980). More typically, respirators may be made available
for use in emergency situations or maintenance and repair operations
(McLeod 1980; Skocypec 1980).
5.4 Summary
Table 5-7 presents a matrix relating the available engineering,
workplace design, and work practice control measures to the specific
exposure sources to which they are, or may be, applicable. In
general, engineering controls are specific to particular exposure
sources while workplace design and work practice measures are more
generally applicable.
A major part of the effort to date in addressing worker expo-
sure has focused on exposure occurring to the chamber operator when
5-39
-------
TABLE 5-7
SUMMARY OF AVAILABLE CONTROL MEASURES TO MITIGATE WORKER EXPOSURE TO ETO
Common
Uncommon
Exposure Source
ot Event
Control Measure
Gas Delivery System
Leaks
Door Gasket Leaks 1
Leaks Due to |
! Equipment Design j
Discharge to
Sewer Drain
Chambers Vented
to Workplace
Chamber Vent
Line Leaks J
[unloading Chamber 1
Transfer of Freshly
Treated Goods
Offgassing from
Treated Goods
in Storage ,
Releases from
Aeration Cabinets
Cylinder Changeover
Operations j
Failure of Door 1
Locking Mechanism
Maintenance or Repair
Work Resulting from
System Malfunction
Release of Emergency
Relief Valve
Major ETO Leak
or Spill
Engineering Controls
Automatic leak detection
and control system
Improved chamber evacua-
tion system
V
Drain venting modification
(liquid/gas separator)
Remote-control door open-
ing system
V
Chamber ventilation
Systems
Differential pressure
ventilation system
V
Local exhaust hooda
y/
V
V
V
V
Gas line check valves
V
Vent connection for
chamber pressure relief
valve
Vent connection for
aeration cabinet
V
Workplace Design
General area ventilation^
y/
V
v'
V
V
V
v
V
a
Local exhaust ventilation
V
~
V
V
V
y/
V
V
V
y/
>/
V
V
y/
Partitions
V
y
V
V
y/
V
V
V
y/
Location of equipment and
work stations**
V
<~
V
¦ V
y/
V
V
V
V
V
V
y/
Work Practices
Door opening procedures
V
Material handling
procedures
V
Equipment maintenance
V
V
V
v/
Protective clothing
V
V
V
V
Respiratory equipment
y/
V
v'
V
®Local exhaust hoods, classified here as an engineering control measure* are Integral components of
an overall local exhaust ventilation system. As such, possible overlap may occur between these 2
types of control measures*
^General area ventilation and location of equipment and work stations are Intended to control
passive exposure to ETO that may result from any source of release. As such* they are generally
applicable, rather than specific, control measures.
5-40
-------
the chamber door is initially opened. Various engineering controls
have been developed, including various approaches to Improving the
effectiveness of the chamber evacuation system, chamber ventilation
systems to capture and remove ETO once the chamber door Is opened
and systems which permit the chamber door to be opened from a
remote location. In addition, local exhaust systems, specific work
i «
practices such as procedures to be followed in opening the chamber
door, and use of respiratory equipment are alternative or, in some
instances, complementary approaches. Less systematic attention has
been directed towards other potential exposure sources, possibly
because they are less routine occurrences or less likely to result
in high levels of worker exposure.
5-41
-------
6.0 IMPLEMENTATION OF MEASURES TO CONTROL AND MONITOR WORKER EXPO-
SURE TO ETO AND POTENTIAL EXPOSURE SITUATIONS AT SELECTED SITES
Control techniques to minimize worker exposure to ETO have been
implemented in varying degrees at the 12 user sites examined in this
study. In addition, the extent of use of equipment designed to moni-
tor environmental levels of ETO in the workplace and the extent and
specific instances of worker exposure to ETO differed among and with-
in these 12 sites.
Information was collected from individual facilities that use
ETO at 12 industrial, agricultural, research, and institutional
sites. These facilities were requested to supply information regard-
ing their ETO sterilization/fumigation equipment and work practices,
the extent to which they have implemented control measures to mini-
mize worker exposure to ETO at their respective facilities, and the
nature and effectiveness of any modifications made to equipment,
workplace design, or work practices. In addition, information was
requested on the nature and extent of any ETO monitoring programs
that have been implemented and regarding any potential situations of
worker exposure to ETO that have been identified.* This information
is discussed below and summarized in Table 6-1. Detailed information
*Situations of potential worker exposure to ETO were also
determined by MITRE based upon the engineering modifications (and
equipment descriptions), workplace design, and work practices
reported by the individual facilities at each site of use.
Identification of such situations does not indicate that individual
facilities regarded these situations as potential problems or
hazards to their employees.
6-1
-------
a>
i
to
pairy Packaging
Industry®
Cosmetics Industry® j
1
Spices, Seasonings, and
Black Walnut Heats
Industry
Animal and Plant
Service Quarantine at
Ports of Entry1
High Containment
Research laboratories
(in agriculture)
Beekeeping Industry
Transportation Site»3
Research Laboratories
(Microbiological and
Cancer, and Animal
Breeding)
X
c
(it
c
3
CD
j Libraries
Medical Products
Industry
Health Care and Health
Diagnosis and Treatment
Facilities^
\ Extent of
\ Implementation
Site \
Categories \
Ui
Un
r->
oo
w
-
-
ON
fo
N7
Ov
o»
V*
Total
Dumber
©
O
-
?
©
o
o
o
o
-
u>
Automatic Leak ^
Detection Systen
pj
3
X>
M*
9
ft
A
n
H»
S
90
»
O
a.
H-
n
ft
rt
H-
0
s
n
o
a
rr
in
UN
oo
z
>
to
\©
z
>
u>
.e-
u»
ro
ro
u>
sj
Chamber Evacuation System (includes
multiple or pulsating t>ost-vacuums
or air wash)
U*
vj*
JO
§
l>
o
5
-
ro
o
ro
w
Liquid/Gas
Separatore
O
O
-
z
>
o
o
?
o
O
o
O
O
Remote Control
Door Openingf
O
O
o
g
o
-
g
-
o
o
io
ro
Chamber Ventilation System (includes
differential pressure chamber venti-
lation system or local exhaust hood)
o
o
o
z
>
o
o
g
©
o
o
o
-
Gas Line
Check Valves
Z
>
z
>
z
>
z
>
z
>
z
>
5
o
o
o
X-
co
Aeration Cabinet
Venting SvstemS
u«
v/«
-
ro
*¦
£
JS
o
ro
.c-
•C-
<£
General Area
Ventilation System
Workplace Design
H*
X
0
CD
(0
c
ft
to
'V
O
O
VI
CD
o
o
ro
o
S3
w
vO
Local Exhaust
Vent i la t ion Sy s f f»n»
u>
c*.
-
-
u>
~
nj
fO
u>
co
m
Isolation (includes use of partitions
or location of equipment or work
stations)
cn
V*
ro
O
00
U>
to
-
-
Ul
>X>
ro
o*
C*
O
Operator Training (provided either by
chamber manufacturer, accredited organi-
zation, ot under in-house supervision)
Work Practices
Ul
U1
oo
00
un
-
-
U>
ro
KS
Equipment Operation
Procedures
k/l
Ln
C*
-
©
«-n
5
o
-
o
ro
o
W
w
Material Handling
Procedures
m
SC
?
ro
5
u>
ro
N>
ro
Of
un
&
Regularly Scheduled Program of Equipment
Inspection and Maintenance
O
O
u
-
-
w
~
ro
ro
-
«o
£-
Personal Protective
Equipment
en
un
IS)
-
-
_
u>
w
-
ro
S>
Monitoring of Worker
Exposure to ET0c
so w
z
m H
x
o
H H
> M
H §
cn
V) 30
t-i tfl
-3 t/J
II
os r*
-------
TABLE 6-1 (CONCLUDED)
"Extent of impleaientatIon Is shorn in terms of the nuaber and percent (nuaber/percent) of facilities at each site of ETO use that
implements the control and monitoring measures.
i>These control measures are discussed in Section 5.0.
cData on the different types of monitoring techniques, and on their respective advantages and 1imitations, are presented in Section 3.0.
dThls system Is coMerclslly available in sterilizers Manufactured by 3M (Models 202B and 400B) and AMSCO (Eagle series). Some industrial
chambers, such as those Manufactured by Vacudyne Altalr, aay incorporate such features.
liquid/gas separator can be used on only those chaabers which vent spent gas mixtures to the sewer drain. The percentages presented
are the ratio of facilities using liquid/gas separators to the nuaber of facilities that report venting spent gas mixtures to the sever
drain.
fThis feature has been custoa designed by Beverly Pacific.
'This system Is applicable only to those facilities that use a mechanical aeration cabinet. This system is not applicable (NA) to sites
*'lere aeration takes place In aeration rooms or areas (23 medical products firms and the spice, cosmetics, and dairy packaging industries)
where aeration is conducted outdoors (transportation sites, bee keeping industry, high containment research laboratories in agriculture,
and animal and plant service quarantine at ports of entry).
I ^Thls category represents data collected only froa hospitals. It was not possible to identify health diagnosis and treatment facilities
(doctors, dentists, and veterinarians in private or clinical practices) who may be using ETO sterilization equipment.
*One medical products industry facility reported use of a Beverly Pacific sterilizer. This facility reported that the sterilizer doors
are automatically cracked open, but did not specify whether it Is remotely controlled.
fumigation and aeration of railroad passenger cars are conducted without the use of any containment equipment; therefore, the control mea-
sures regarding engineering modifications, general area and local exhaust ventilation systems, material handling procedures, and equipment
Inspection and maintenance are not applicable (HA) to this site.
L
Four of these facilities conduct ETO fumigation Indoors. Two of these four facilities have Implemented this control measure.
^Fumigation and aeration at this site Is performed with the use of a tarpaulin; therefore, the engineering modifications and equipment
Inspection and maintenance wort practices control aeasures are not applicable (HA.) to this site. The general area ventilation systems
control measure is applicable to the three ports of entry that conduct fumigation indoors; however, only one of these three facilities (33
percent) has implnmr nted this control measure. The six other control aeasures and monitoring are applicable to all of the eight ports of
entry facilities.
"Micro-Biotrol Company, a contract sterilizer/fuaigator, fumigates approximately 80 to 84 percent of the cosmetic raw materials and 100
percent of the hardware items used by the cosmetics industry (as determined by MITRE) (Butcher and Goldgraben 1980). In addition, Micro-
Biotrol sterilizes dairy packaging products (77 percent of those sterilized with ETO), spices, and medical products (Smith 1980b). These
data represent the extent of implementation of control and monitoring measures at the five sterilization/fumigation facilities operated
by Mlcro-Blotrol.
-------
regarding each facility is presented in Appendix C. The criteria
used to select the individual facilities contacted for this report
are also presented below.
6.1 Health Care and Health Diagnosis and Treatment Facilities
6.1.1 Use of ETO in Health Care Facilities
ETO is used in hospitals and other health care facilities to
sterilize items used in medical care that are not purchased in a
sterile state and that may not be processed by steam sterilization
because they will be damaged or rendered ineffective by the heat or
moisture. The following section summarizes the responses of 65
health care facilities and includes responses from 62 hospitals (of
200 contacted) to an American Hospital Association (AHA) survey and
three hospitals to which site visits were made.* Information
obtained from the 65 facilities regarding measures implemented to
control and monitor worker exposure to ETO is detailed in Appendix C
(Table C-l) and discussed below.
6.1.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
health care facilities may result from a number of work practices and
workplace design features.
• ETO sterilizer operators did not receive formal training in
ETO sterilization procedures either from the chamber manufac-
turer or under "in-service" supervision at five health care
facilities.
*A total of 67 hospitals (34 percent) responded to the AHA survey.
Of these, five reported no use of ETO. All 65 respondents who pro-
vided information are members of the American Hospital Association.
-------
• Of those hospitals specifying procedures followed in operat-
ing and unloading the equipment, 3 of 54 indicated that the
sterilizer was unloaded immediately upon door opening.* An
additional 11 facilities did not indicate if the recommended
unloading procedures were being followed.
• Nine health care facilities did not utilize a regularly
scheduled program of equipment inspection and maintenance.
• Employees at many health care facilities may be exposed to
ETO due to inadequate aerator venting. At eight facilities
aerators are vented to the workplace or to rooms located
adjacent to the workplace. At one of these eight facilities,
treated materials are left in an unspecified area near the
chamber to aerate when its aerators are at full capacity.
Fourteen facilities did not indicate where their aerators are
vented,
6.1.3 Control Measures
Sterilizer operators at many health care facilities use ETO
sterilization equipment designed with certain engineering
features or follow certain work practices which serve to control
worker exposure to ETO.
• Automatic leak detection systems are incorporated in the
chambers used at three health care facilities (two 3M Model
400B and one AMSCO Eagle Series sterilizers). These systems
monitor the vacuum or pressure levels in the chamber and
either alert the operator or automatically abort the cycle in
the event of a variance.
It should be noted that one of these three facilities reported
that its chamber is equipped to perform multiple post-vacuums
(which may decrease ETO concentrations released to the workplace
upon opening the chamber door).
**In general, these facilities did not indicate whether the engi-
neering features were part of the original design or were installed
as a modification at a later date. Such information is presented
where it is available.
6-5
-------
ETO sterilizers at 37 health care facilities are equipped
with various types of improved chamber evacuation systems,
including multiple or pulsating post-vacuums and air washes.
Check valves have been installed in ETO supply lines at one
health care facility. These one-way check valves, installed
close to the tank connection, serve to reduce the amount of
ETO to which the worker changing the tank cylinder is exposed
by shortening the length of line which must be bled when emp-
tied cylinders are replaced. Another facility reported the
installation of ball joints in the ETO gas supply lines to
achieve the same type of reduction in worker exposure.
Aeration cabinets at 43 health care facilities are vented to
the outside atmosphere.
Use of area ventilation systems were reported by 49 health
care facilities.
Access to the ETO sterilization area is restricted or the ETO
work area is isolated from other areas in the workplace at 54
of the 65 health care facilities.
Sterilizer operators at 60 health care facilities have
received training in ETO sterilization procedures either from
the chamber manufacturer or under "in-service" supervision.
In addition, many of these facilities have posted a list of
ETO sterilizer operating procedures near the chamber.
Sterilizer operators at 51 health care facilities leave the
chamber door open at the completion of the sterilization
cycle for a short period of time (to permit residual ETO gas
to dissipate) before unloading the treated materials from the
chamber.
Material handling equipment, such as baskets and rolling
carts, are used to transfer treated materials from the steri-
lizer to the aerator at 33 facilities.
A regularly scheduled program of equipment inspection and
maintenance is conducted by the manufacturer or by hospital
maintenance personnel at 56 facilities.
Personal protective equipment, including gloves, goggles, and
respirators, is worn by operators while operating the chamber
or while unloading or handling ETO-treated materials at 47
facilities.
6-6
-------
6.1.4 Monitoring
Forty-one of the 65 facilities contacted reported the use of
monitoring equipment to determine ambient ETO concentrations in the
workplace. The types of equipment used to monitor the workplace
include Wilks-Miran gas analyzers (12), Draeger multi-gas detectors
(11), and gas chromatography (presumably in conjunction with person-
nel monitoring equipment) (6).
Two facilities reported that modifications have been made to the
sterilization equipment and to room ventilation systems in response
to the results obtained from monitoring of the workplace. These mod-
ifications include increasing the rate of air exchanges in the ETO
work area from 6.6 to 10.3 air changes per hour, installing a pulsat-
ing post-vacuum at the completion of the sterilization cycle, and
installing a reducer in the exhaust line to slow the rate of water
released from the chamber. In addition, one facility plans to vent
its aerator to the outside atmosphere and modify its chamber venting
system (but did not specify its plans on the schedule for implement-
ing these changes).
Specific information on the types of monitoring equipment used,
the results obtained, and the modifications made to existing systems
at each of the 65 individual health care facilities is detailed in
Appendix C (Table C-l).
6-7
-------
6.2 Medical Products Industry
6.2.1 Use of ETO By the Medical Products Industry
ETO sterilization has been an important factor in the develop-
ment and manufacture of low cost, single use sterile medical items.
Approximately 80 percent of the 25,000 finished medical devices and
products manufactured by this industry are sterilized with ETO.
These devices and products, which include heart pacemakers, dialyz-
ers, respiratory care nebulizers and other products, are used primar-
ily by hospitals and health care facilities, clinical laboratories,
physicians providing services in their offices, and nursing homes
(Phillips et al. 1978; HIMA 1979).
The following section summarizes the responses from 26 industri-
al medical-products manufacturers. Of these, 23 facilities responded
to a survey conducted by the Health Industry Manufacturers Associa-
tion and three provided information during site visits to their
facilities. Ninety-six percent of these companies are members of the
Health Industry Manufacturers Association. Information obtained from
the 26 facilities with respect to measures implemented to control and
monitor worker exposure to ETO is detailed in Appendix C (Table C-2)
and discussed below.
6.2.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
medical products facilities may result from a number of work prac-
tices and workplace design features.
6-8
-------
• At four medical products firms treated materials are unloaded
from the sterilizer immediately after opening the chamber
door.*
• Sterilizer operators enter the sterilizer to unload the
treated products at 12 facilities.*
• Access to ETO sterilization areas is not limited to ETO
sterilization workers or authorized personnel at five medical
products facilities.
• Employees at 12 of the 26 medical products firms may be ex-
posed to ETO due to workplace design and aeration methods.
At these facilities treated materials are not aerated in
separate, ventilated rooms but in the general warehouse area
which is not equipped with any mechanical ventilation system
(3), in warehouse areas specially designated as aeration
areas but lacking special ventilation (5), or in ventilated
general warehouse aeration areas (A). These 12 facilities did
not report whether personnel not involved in the steriliza-
tion process were routed around or away from the aerating
material, or if these areas were near walkways available for
general use.
6.2.3 Control Measures
Sterilizer operators at the 26 medical products firms use ETO
sterilization equipment designed with certain engineering features,
work in areas with proper workplace designs, or follow certain work
practices to control worker exposure to ETO.
• An automatic leak detection system which monitors the vacuum
or pressure levels in the chamber and alerts the operator of
abnormal equipment operations has been installed in the cham-
ber at one medical products facility.
*It should be noted that various types of chamber evacuation sys-
tems are utilized at these facilities which may decrease ETO concen-
trations released to the workplace upon opening the chamber door.
6-9
-------
• Sterilization chambers at 22 of the 26 medical products firms
are equipped to perform multiple post-vacuums or air washes
at the completion of the sterilization cycle.*
• Two facilities** utilize a liquid/gas separator to reduce
the amount of ETO which is released at the drain during the
exhaust phase of the sterilization cycle.
• A differential pressure chamber ventilation system has been
incorporated into the operation of the sterilizer at one
facility. The vacuum pump is used to draw ambient air into
the chamber to vent/dilute the sterilant gas remaining in the
chamber at the end of the sterilization cycle.
• Local exhaust (canopy) hoods are located over 2 sterilizers
(out of 17) at one facility. These hoods are designed to
capture ETO as it is released from the sterilizer and prevent
its dispersion throughout the workplace.
• Medical products firms employ different methods for aerating
ETO-treated materials. Of the 26 firms contacted, three use
aerators vented to the atmosphere, five aerate treated goods
in separate rooms vented to the atmosphere, and 12 aerate the
treated goods in warehouse areas that are unoccupied,
isolated from other work areas, or are designated as
quarantine or "on-test".***
• General area ventilation systems are used at 24 of the 26
medical products facilities.
*0f the four other firms, two have sterilizers that draw only one
vacuum, one did not report this datum, and the fourth uses the
Sterijet® system to treat its materials. The operation of the
Sterijet® system is explained in Section 2.2.2.
**Six facilities reported that their sterilizers are vented to the
drain. Sterilizers are vented to the atmosphere at 21 facilities
(of which two vent at least one of their sterilizers to the drain
as well).
***Five facilities did not report where treated goods were aerated,
while a sixth facility reported that its chamber is a self-
contained unit and that complete aeration occurs prior to the
removal of treated materials from the chamber. The chamber
evacuation system at this facility incorporates two post-vacuums
and one air wash.
6-10
-------
• Local exhaust ventilation systems are used by three
facilities. Upon the opening of the chamber door at one
facility, a 2200 cubic foot per minute exhaust blower (which
is connected to a grate-covered pit in front of the steri-
lizer) captures sterilant gas which nay be emitted from the
chamber. Another facility has a slotted "pickup" (grille) at
the bottom of the door and at the floor drain which provides
a rate of air exchange of 1400 cubic feet per minute.
• Access to the ETO sterilization area is restricted to autho-
rized personnel or ETO sterilization workers at 18
facilities.
• Sterilizer operators at all 26 medical products firms have
received training in ETO sterilization procedures either from
the chamber manufacturer or under in-house supervision,
• Sterilizer operators at 22 of the 26 medical product firms
follow specified equipment operation procedures, such as
leaving the door open at the completion of the sterilization
cycle for a period of time before unloading the treated mate-
rials from the chamber,
• Operators use forklifts or hand trucks to transfer treated
materials from the chamber to aeration areas at 20 medical
products firms. Treated materials are not, in these
instances, transferred manually,
• A regularly scheduled program of equipment inspection and
maintenance is utilized at 25 medical product firms. The
26th firm did not indicate whether such a program was
instituted.
• Sterilizer operators at 19 facilities wear protective cloth-
ing or equipment when unloading treated materials from the
chambers or when changing ETO gas cylinders. The types of
equipment used include gas masks, face shields, respirators,
goggles, and gloves.
6.2,4 Monitoring
Twenty-four medical products firms reported that monitoring of
the workplace had been conducted to determine ambient ETO concentra-
tions. The types of monitoring equipment used at these facilities
include gas chromatographs (presumably in combination with charcoal
6-11
-------
tube personnel monitors) and Wilks-Miran infrared gas analyzers
(models 101 and 103). Eleven of these facilities reported that
specific changes had been made to sterilization equipment, workplace
design, and work practices in response to the results obtained from
such monitoring. None of these facilities, however, reported spe-
cific monitoring data either prior to or after implementation of con-
trol measures.
6.3 Libraries
6.3.1 Use of ETO in Libraries
Libraries use ETO fumigation to support the preservation and
restoration of rare book collections, special collections, or
archives, and to treat new library acquisitions (Goldgraben 1980)#
In Preliminary Benefits Analysis of Ethylene Oxide as a Fumigant
in Libraries (Goldgraben 1980), MITRE reported on the use of ETO by
27 libraries, public archives, historical societies, and other
library institutions that contained a minimum of 3,500,000 volumes or
rare book collections of at least 10,000 volumes (Goldgraben 1980).
Those libraries that had reported an annual ETO consumption of at
least 25 pounds (12 of the 17) were contacted and requested to supply
additional information for this report. The information obtained
from the 12 libraries with respect to measures implemented to control
and monitor worker exposure to ETO is detailed in Appendix C (Table
C-3) and discussed below.
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6.3.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
libraries may result from a number of work practices and workplace
design features.
• ETO operators did not receive formal training either from the
chamber manufacturer or in an accredited safety program at 3
of the 12 libraries. While such training had been offered at
the other nine libraries, descriptions of operating practices
at these sites suggest that such training may not have been
comprehensive or that the operator may not be adequately
supervised.
• ETO fumigation chambers at five of the libraries are not
opened immediately upon completion of the fumigation cycle.
At these libraries, the delays range from 1 to 24 hours and
may result in elevated ETO concentrations to which the oper-
ator may be exposed upon opening the chamber door.
• Chamber operators at 6 of the 12 libraries unload the treated
materials from the sterilizer immediately after opening the
sterilizer door.*
• At one of the libraries the operator leaves the chamber door
open at the end of the cycle for 24 hours (to permit residual
ETO gas to dissipate) before unloading the treated materials;
however, personnel work stations are located in the same room
as the open chamber (Bentley 1980).
• Chamber operators at 11 of the 12 libraries do not wear any
protective clothing or equipment while operating the chamber
or while unloading or handling the ETO-treated materials.
Two of the facilities provide respiratory equipment for use
in emergency situations.
• Ten of the 12 libraries did not utilize a regularly scheduled
program of equipment inspection and maintenance. The absence
of such preventive maintenance may result in leakage from the
ETO chamber, gas delivery systemt or vent system which may,
in turn, result in potentially chronic ETO release to the
workplace.
*It should be noted that various types of chamber evacuation
systems are utilized at these facilities which may decrease ETO
concentrations released to the workplace upon opening the chamber
-------
• Employees at many of these libraries may be exposed to ETO
due to workplace design features and aeration methods. None
of the 12 libraries reported use of a mechanical aerator to
accelerate the elution of ETO residual gas from the treated
materials. ETO-treated materials were transferred to storage
areas at five libraries, to open shelves (in an un-specified
area) at one library, and to a hallway until they could be
shelved at a later date at another library. The other five
libraries did not report the manner in which treated mate-
rials were aerated at their facilities.
6.3.3 Control Measures
Many libraries use ETO fumigation equipment designed with engi-
neering features* or follow work practices which serve to control
worker exposure to ETO.
• Fumigation chambers at 4 of the 12 libraries are equipped
with multiple post-vacuum evacuation systems.
• One library had installed an internal external exhaust system
in the chamber which is operated for a 12-hour period after
the completion of the fumigation cycle (with the chamber door
open).
• Chamber operators at nine of the libraries have received
training in ETO fumigation procedures from the chamber manu-
facturer or under in-house supervision.
• ETO fumigation of library materials is conducted in a
restricted area at three of the libraries.
• Chamber operators leave the chamber door open for a period
ranging from 1 to 48 hours before unloading the treated mate-
rials at six of the libraries.
6.3.4 Monitoring
One of the 12 libraries reported the use of monitoring equipment
to determine ambient ETO concentrations in the workplace. The
*These facilities did not indicate whether the engineering mea-
sures were part of the original chamber design or were installed as
a modification at a later date.
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Library of Congress conducted a monitoring program in 1976 using
charcoal tubes, and reported average exposure levels of 0.5 ppm
(McComb 1980). None of the other 11 libraries reported the use of
any monitoring equipment to determine levels of ETO in the workplace
or reported any programs to evaluate situations leading to worker
exposure.
6.4 Museums
6.4.1 Use of ETO in Museums
Museums use ETO as a fumigant to eliminate several types of
organisms which attack a wide variety of organic materials (including
ethnographic items, furniture, wooden artifacts, and textiles) and to
fumigate new museum acquisitions and materials that had been loaned
to other institutions (Canellos 1980).
In Preliminary Benefits Analysis of Ethylene Oxide as a Fumigant
in Museums (Canellos 1980), MITRE reported on the use of ETO by 12
museums which were located in urban areas having a population of at
least one million and accredited by the American Association of
Museums. These museums were also selected to reflect the different
types of museums, including art, science, and natural history
(Canellos 1980). Those museums that reported an annual consumption
of ETO of greater than 20 pounds (7 of the 12) were contacted and
requested to supply additional information for this report.
The information obtained from these museums with respect to mea-
sures implemented to control and monitor worker exposure to ETO is
detailed in Appendix C (Table C-4) and discussed below.
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6.4.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
museums nay result from a number of work practices, workplace
ventilation, and location of ETO equipment in areas with unrestricted
access.
• ETO chamber operators at two of the seven museums did not
receive formal training either from the chamber manufacturer
or in an accredited safety program. While operators at the
other five museums had undergone such training, descriptions
of operating practices at these sites suggest that such
training may not have been comprehensive or that the operator
may not be adequately supervised.
• Chamber operators at four of the museums unload the treated
materials from the chamber immediately after opening the
chamber door. It should be noted that various types of cham-
ber evacuation systems (which may decrease ETO concentrations
released to the workplace upon opening the chamber door) are
utilized at two of these facilities; however, at the other
two museums the treated goods are unloaded after having been
left in a closed chamber for periods up to 48 hours after the
conclusion of the fumigation cycle.
• Operators at four of the museums do not wear protective
clothing or equipment while operating the chamber or while
unloading or handling the ETO-treated materials. At two of
these four museums, the chamber operators manually unload
treated materials from the fumigation chamber.
• Four of seven museums did not utilize a regularly scheduled
program of equipment inspection and maintenance.
• Five museums reported that no aeration procedures are
observed.
• Six of the museums reported that ventilation in the fumiga-
tion room is limited.
• Three museums reported that ETO fumigation is conducted in
unrestricted areas. At another museum, employees in a
loading area adjoining the chamber room may be passively
exposed to ETO due to a window-size opening between the two
rooms.
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6.4.3 Control Measures
Some museums use ETO fumigation equipment with specific engi-
neering features* or follow work practices which serve to control
worker exposure to ETO.
• Chambers at two of the seven museums are equipped to create
five post-vacuums at the end of the fumigation cycle. At one
of these museums the chamber had been modified to incorporate
this feature after workplace monitoring had been conducted.
• The chambers at two museums incorporate air wash cycles of 3
hours and 24 hours, respectively.
• One museum reports use of a "back-flow" meter to monitor
backups in the gas vent hose during the chamber exhaust
phase.
• General area ventilation systems are used by four museums:
two museums reported 10 air changes per hour in the fumiga-
tion room and 8 to 10 air changes per hour in aeration areas;
fumigation is performed in a trailer equipped with four vents
and a fan at the third museum; and exhaust fans are installed
in the chamber room for use in the summer months at the
fourth museum.
• Chamber operators at four museums have received training in
ETO fumigation procedures either from the chamber manufac-
turer (1) or under in-house supervision (3). A fifth museum
reported that its operator had been certified by the State of
Delaware, but did not indicate where he had received his
fumigation training.
• Operators at three museums leave the chamber door open for a
period ranging from 30 minutes to at least 4 hours before
unloading the treated materials.
*In general, these facilities did not indicate whether the engi-
neering features were part of the original chamber design or were
installed as a modification at a later date. Such information is
presented where it is available.
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6.4.4 Monitoring
Three of the museums reported that monitoring of the workplace
had been conducted to determine ambient ETO concentrations.
• One museum reported that monitoring had been conducted when
the fumigation equipment was initially installed in 1976;
however, monitoring data were not made available. This
museum also reported use of a halide leak detector* (Brown
1980).
• One museum conducted monitoring in 1978 using a Wilks-Miran
infrared gas analyzer. ETO concentrations in excess of 250
ppm were recorded upon opening the chamber door. In response
to these data, this museum reported that it had modified its
fumigation equipment and procedures (the only modification
reported by this museum was the adjustment made to the cham-
ber to automatically create up to five successive post-
vacuums) . Monitoring had not been subsequently performed to
determine the effectiveness of the modifications. This
museum also uses a halide detector around the chamber seals
and gaskets to detect leakage.
• One museum reported that it had tested its chamber for leak-
age and used a gas chromatograph to analyze the samples, but
did not provide additional data (Reilly 1980).
6.5 "Research Laboratories
6.5.1 Use of ETO in Research Laboratories
Animal breeding facilities and microbiological and cancer
research facilities use ETO as a sterilant to treat heat sensitive
plastic articles, delicate electronic equipment, and prepackaged
laboratory items. Animal breeding facilities, for example, require
sterilized items in order to rear animals in a germ-free environment.
Microbiological and cancer research laboratories require sterile
*Halide detectors detect the presence of Freon®.
6-18
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equipment to prevent the contamination of cultures and laboratory
equipment (Zank et al. 1980)
In Preliminary Benefits Analysis of Ethylene Oxide as a Sterll-
ant in Research Laboratories (Zank et al. 1980), MITRE reported on
the use of ETO by five animal breeding facilities and seven microbio-
logical and cancer research facilities (Zank et al. 1980). Those re-
search facilities that reported an annual ETO consumption of at least
20 pounds (6 of the 12) were contacted and requested to supply addi-
tional information for this report. The information obtained from
the six facilities with respect to measures implemented to control
and monitor worker exposure to ETO is detailed in Appendix C (Table
C-5) and discussed below.
6.5.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
research facilities may result from a number of work practices and
workplace design features.
• ETO sterilizer operators did not receive formal training in
ETO procedures either from the chamber manufacturer or in an
accredited safety program at three of the six research labo-
ratories. While operators at the other three research
facilities had undergone such training, descriptions of the
operating practices at these facilities suggest that such
training may not have been comprehensive or that the operator
may not be adequately supervised.
• Sterilizer operators at five of the six research laboratories
unload the treated materials from the sterilizer immediately
after opening the chamber door. At four of these facilities
this follows a period (of several hours) during which the
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treated materials remained in the closed chamber after the
completion of the sterilization cycle.*
• Sterilizer operators at five of the six research laboratories
do not wear protective clothing or equipment while operating
the sterilizer or while unloading or handling the ETO-treated
materials.**
• Mechanical aeration chambers are used at only one research
laboratory, but this aerator is vented into the workplace.
Two other research laboratories reported that ETO-treated
materials are aerated in a holding area and in the sterilizer
room, respectively. Three other facilities did not report
the method by which they aerate ETO-treated materials.
• Three of the six research laboratories did not utilize a
regularly scheduled program of equipment inspection and
maintenance.
• Three research laboratories reported that ETO sterilization
is conducted in unrestricted areas.
6.5.3 Control Measures
Many research laboratories use ETO sterilization equipment
designed with specific engineering features*** or follow work prac-
tices which serve to control worker exposure to ETO.
*It should be noted that the sixth research facility does allow a
time delay between the opening of the door and unloading of the
chamber; however, the treated materials are left in the closed
chamber for a period after cycle completion (Bolte 1980).
At one of these five facilities the operator does wear eye gog-
gles when changing the ETO gas cylinders (Davis 1980). At the
sixth research laboratory, protective equipment are not worn when
loading the sterilizer (in a non-sterile area) but are worn when
the sterilizer is opened (into the sterile area) (Fitch 1980).
***None of these facilities indicated whether the engineering fea-
tures were part of the original chamber design or were installed
as a modification at a later date.
6-20
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• Sterilization chambers at three research laboratories are
equipped to create multiple post-vacuums at the end of the
sterilization cycle. At one of these three facilities, the
post-vacuums are followed by a 30-minute air-wash cycle.
• General area ventilation systems have been installed at four
research laboratories. Two facilities report air exchange
rates of 6-10 changes per hour in the chamber room, while
a third reports an air exchange rate of 13 changes per hour
in a "clean area" into which treated materials are unloaded.
At a fourth facility, the chamber room is ventilated and
equipped with an exhaust fan.
• Two facilities have installed chamber exhaust systems near
the chambers to capture and remove ETO contaminants before
the ETO diffuses into the work environment.
• Sterilizer operators at three research laboratories have
received training in ETO sterilization procedures either
from the chamber manufacturer (1) or under in-house
supervision (2).
• Three of the research facilities utilize a regularly sched-
uled program of equipment inspection and maintenance.
6.5.4 Monitoring
Three of the research laboratories reported that monitoring of
the workplace had been conducted to determine ambient ETO
concentrations.
• One research laboratory monitors the sterilization area
with a Wilks-Miran 101 infrared gas analyzer on a continu-
ous basis. In addition, an alarm system in the workplace
is activated when ETO concentrations exceed 50 ppm. This
facility reported that such levels have not been attained.
Another research laboratory reported the use of an alarm
system to warn the employees when ETO concentration levels
exceed 50 ppm.
• One research laboratory measured the levels of ambient ETO
to which its workers were exposed using an (unspecified)
charcoal tube method. Samples of ambient air were taken
while the operator was operating and unloading the chamber,
and while changing the ETO gas cylinders. The facility
6-21
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reported that very low levels of ETO were detected; however,
no specific data were reported. The testing was conducted
in 1979.
• Another research laboratory also measured the levels of ambi-
ent ETO to which its workers were being exposed using Draeger
colorimetric indicator tubes. ETO concentrations ranging
from 20 to 50 ppm were detected at the breathing zone level
after the chamber door was opened at the end of the cycle.
6.6 Transportation Sites
At present, ETO is used as a fumigant to eliminate serious
insect and rodent infestations in railroad passenger cars. ETO is
also registered as a fumigant for buses, trucks, domestic and mili-
tary aircraft, ship cargo holds, and railroad freight cars; however,
other methods of fumigation and pest control are used at these sites
(Canellos et al. 1980).
In Preliminary Benefits Analysis of Ethylene Oxide at Transpor-
tation Sites (Canellos et al. 1980), MITRE reported on the use of ETO
to fumigate railroad passenger cars operated by AMTRAK (five other
rail carriers reported that they did not use ETO) (Canellos et al.
1980).
Unlike most of the other ETO user sites examined in this report
(except for ports of entry), ETO fumigation at railroad sites is
conducted without the use of a chamber or other type of containment
equipment.* In addition, the fumigation of railroad cars is car-
ried out by professional extermination firms whose employees follow
*ET0 fumigation of railroad cars Is described in Section 2.3.
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obtained from the 17 beekeeping facilities regarding measures imple-
mented to control and monitor worker exposure to ETO is detailed in
Appendix C (Table C-7) and discussed below.
6.7.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
beekeeping facilities may result from a number of work practices.
• ETO operators at 14 of the beekeeping facilities did not
receive formal training either from the chamber manufacturer
or in an accredited safety program.
• Operators at 14 beekeeping facilities manually carry treated
materials from the fumigation chamber. At two of these
facilities, operators manually remove and carry these treated
materials from the chamber immediately after opening the
chamber door.
6.7.3 Control Measures
The beekeeping facilities contacted for this report use ETO
fumigation equipment designed with engineering features or follow
work practices which serve to control worker exposure to ETO.
• Fumigation chambers at 9 of the 17 beekeeping facilities are
equipped with "improved" chamber evacuation systems: at
eight facilities the chambers are equipped to create multiple
post-vacuums at the end of the fumigation cycle and at one
facility the vacuum pump is operated for a 20-minute period
after the chamber door is opened.
• Fumigation is conducted outdoors at 12 of the 17 beekeeping
facilities and indoors in a restricted area at one facility.
• Chamber operators leave the chamber door open for a period
ranging from 5 minutes to 24 hours before unloading the
treated materials from the chambers at 15 beekeeping
facilities.
• Treated materials are removed from the chamber on pallets at
four facilities and on carts at one beekeeping facility.
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and diagnosis of domestic and exotic (foreign) plant and animal dis-
ease pathogens (USDA 1978). These laboratories were contacted to
obtain information on their ETO operations. The information obtained
from the three facilities with respect to measures implemented to
control and monitor worker exposure to ETO is detailed in Appendix C
(Table C-8) and discussed below.
6.8.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
high containment research laboratories may result from a number of
work practices.
• Sterilizer operators at one of the three high containment
research laboratory unload the treated materials from the
sterilizer immediately after opening the chamber door.*
• Sterilizer operators at one facility may, on occasion, enter
the chamber to remove treated materials. These workers do
not utilize protective clothing or equipment when they enter
the chamber; however, the chamber is usually left open to air
out overnight before the treated materials are removed.
• One of the three high containment research laboratories does
not utilize a regularly scheduled program of equipment
inspection and maintenance, while another facility permitted
its engineering staff (untrained in ETO use and its associ-
ated health hazards) to repair the sterilization equipment.
6.8.3 Control Measures
Sterilizer operators at the three high containment research
laboratories use ETO sterilization equipment designed with engi-
neering features, work in areas with workplace designs features,
*It should be noted that two post-vacuums are drawn in this
sterilizer at the conclusion of the sterilization cycle.
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or follow specific work practices which serve to control worker expo-
sure to ETO.
• Sterilizers at two facilities are equipped to draw two post-
vacuums at the end of the sterilization cycle.
• All three of the facilities have instituted some type of
sterilizer room ventilation system: two high containment
research laboratories reported the use of mechanical general
area ventilation; two facilities reported that air in their
buildings is filtered through High Efficiency Performance
Air (HEPA) filters; and all three facilities reported air
exchange rates ranging from 5 to 15 air changes per hour in
the chamber rooms.
• Sterilizer operators at all three high containment research
laboratories have received training in ETO sterilization pro-
cedures under in-house supervision. Operators at one facil-
ity are designated as safety technicians.
6.8.4 Monitoring
Only one of the high containment research laboratories reported
that it has conducted monitoring in the workplace, specifically to
detect leaks. This facility checked its five ETO sterilizers with
detection devices that were sensitive to leaks at a rate of 10"^
cubic centimenters per second. This facility did not specify either
the equipment that was used or the results obtained (Irish 1980).
6.9 Animal and Plant Service Quarantine at Ports of Entry
6.9.1 Use of ETO at Ports of Entry
Fumigation with ETO as a quarantine treatment for cargo contami-
nated with snails or certain plant disease organisms is required by
the Animal and Plant Health Inspection Service of the U.S. Department
of Agriculture (USDA). These tarpaulin fumigations, which are car-
ried out under the supervision of a USDA Quarantine Inspector, may
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be conducted at any port of entry into the United States where these
normative pests are identified (USDA 1976; Havel 1980).
MITRE contacted contract furaigators at eight ports of entry in
five states and obtained information on their ETO operations. These
contract fumigators perform the ETO fumigation and USDA inspectors
supervise and monitor the fumigation operation (Venech 1980).
6.9.2 Control Measures
ETO fumigation at ports of entry is conducted without the use of
a chamber.* Tarpaulin fumigation is carried out by professional
fumigation firms whose employees follow several work practices to
control worker exposure to ETO.** These procedures, which are
detailed in Appendix C (Table C-9), are summarized below.
• Fumigators at five ports of entry reported that they follow
the tarpaulin fumigation procedures specified in the U.S.
Department of Agriculture Plant Protection and Quarantine
Programs Treatment Manual. Fumigators at the other three
sites did not report compliance with the USDA procedures;
however, these fumigations are supervised by USDA inspectors
and it can be assumed that these three fumigators follow the
procedures as well.
• Fumigation is conducted outdoors at five of the ports of
entry sites and indoors at three sites (in a hangar, mainten-
ance garage, and empty warehouse, respectively) which allow
the fumigation to take place away from general work areas.
*ET0 tarpaulin fumigation at ports of entry is described in
Section 2.2.3.
**Commercial pest control operators are certified pesticide appli-
cators; however, only one certified applicator is required to
supervise the pesticide applications of one firm (Eliades 1980).
It is assumed that the individual operators at these firms have
been trained in fumigation procedures.
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• Placards and guards to warn potential passersby of the fumi-
gation operation are posted at three of the ports of entry
sites.
• Fumigators at seven ports of entry provide gas masks or
self-contained breathing apparatus to operators for use at
their discretion.
• Fumigators at seven ports of entry transport ETO-treated
material by forklift.
6.9.3 Monitoring
Only one of the fumigators reported the use of monitoring equip-
ment to determine ambient ETO concentrations in the workplace. This
fumigator reported use of a combustible gas detector to monitor ETO
concentrations in the empty garage after the tarpaulin is removed.
Additional information was not reported (Gervasoni 1980).
No situations of potential worker exposure to ETO were identi-
fied by the respondents at this site.
6.10 Spices, Seasonings, and Black Walnut Meats Industry
6.10.1 Use of ETO by the Spice Industry
ETO fumigation is used by spice manufacturers and processors as
a disinfectant to control pathogenic organisms that infect spices and
to reduce microbial growth on imported spices (Marsh 1979).
Approximately 27 spice processing companies were requested by
the American Spice Trade Association to provide information regarding
control measures. Of these, responses were received from 21 compa-
nies. The information obtained from these 21 facilities is detailed
in Appendix C (Table C-10) and discussed below.
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6.10.2 Situations Associated with Potential Worker Exposure
Situations associated with potential worker exposure to ETO at
spice industry facilities may result from a number of work practices
and workplace design features.
• At three spice industry firms sterilizer operators unload
treated materials from the sterilizer immediately after open-
ing the chamber door.*
• Sterilizer operators enter the chamber to unload treated
materials at eight spice industry facilities;** however, at
several of these facilities, workers are required to wear
respiratory protection equipment.
• Employees may be exposed to ETO from offgassing from treated
goods at 16 facilities. At these facilities, treated mate-
rials are aerated in the general warehouse in warehouse areas
specially designated as aeration areas but lacking special
ventilation, or in warehouse aeration areas that are vented
to the atmosphere. These facilities did not report whether
personnel not involved in the sterilization process were
routed around or away from the aerating material, or if these
areas were near walkways available for general use.
6.10.3 Control Measures
Sterilizer operators at the 21 spice industry facilities use ETO
sterilization equipment equipped with engineering features or follow
specific work practices to control worker exposure to ETO.
• An automatic leak detection system which monitors the vacuum
or pressure levels in the chamber and alerts the operator of
abnormal equipment operations has been installed in the cham-
ber at one spice industry facility.
*It should be noted that various types of chamber evacuation
systems which may decrease ETO concentrations released to the work-
place upon opening the chamber door are utilized at two of these
three facilities.
ft ft
Five facilities did not report whether their sterilizer operators
enter the chamber to unload the treated materials.
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Area monitoring systems are used by two facilities. Two
facilities use a Honeywell Gas/Vapor Detector for Freon 12 to
monitor gas levels in the ETO work area. The detector is
equipped with a visual and audible alarm system and is
located adjacent to the chamber. Four other facilities
reported that their chambers are equipped with an alarm moni-
toring system, but did not provide further details.
Sterilization chambers at 18 spice industry facilities are
equipped with multiple post-vacuums or air washes to facili-
tate evacuation of gases from the chamber.
Sterilizers at two facilities (among 12 that exhaust spent
gas to the drain) are equipped with a liquid/gas separator.
A remote controlled door opening switch has been installed
into the chamber operating equipment at one spice industry
facility.
General area ventilation systems are used at 16 spice indus-
try facilities.
Access to the ETO sterilization area is restricted or the ETO
work area is isolated from other areas in the workplace at 16
spice industry facilities.
Sterilizer operators at 20 spice industry facilities have
received training in ETO sterilization procedures either from
the chamber manufacturer or under "in-house" supervision.
The sterilizer door is left open for a short period at the
completion of the sterilization cycle (to permit residual ETO
gas to dissipate) before the treated materials are unloaded
from the chamber at 18 facilities.
Material handling equipment, such as forklifts, are used to
transfer treated materials from the sterilizer to aeration
areas at 16 spice industry facilities.
A regularly scheduled program of equipment inspection and
maintenance is conducted either by the chamber manufacturer
or by in-house maintenance personnel at 19 facilities.
Personal protective equipment, including respirators, gloves,
and goggles, is worn by operators while operating the chamber
or while unloading or handling ETO treated materials at 12
facilities.
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6.10.A Monitoring
Monitoring to determine ambient ETO concentrations in the work-
place has been conducted at 12 spice industry facilities.
• Three facilities have conducted monitoring with Wilks-Miran
infrared gas analyzers. One of these three facilities
reported using a Wilks-Miran 101 gas analyzer to monitor all
phases of the ETO operation cycle. In response to the data
obtained from this monitoring, this facility reported
increasing the ventilation over the chamber doors, institut-
ing a 30-minute delay between opening the chamber door and
unloading the treated materials, and requiring the worker to
wear a respirator if entry to the chamber is required during
removal of the treated materials. This facility also
reported that two subsequent monitorings indicated that
worker exposure to ETO has been reduced to 12.6 ppm and 17,4
ppm, respectively, over an 8-hour Time Weighted Average. At
the other two facilities, monitoring was either reported to
be in progress or indicated that ETO levels in the sterilizer
area were below 50 ppm.
• Four facilities conducted monitoring in the workplace follow-
ing the procedures of NIOSH Analytical Method S286.* In
response to the results obtained from monitoring, two of
these facilities have made changes in their operating proce-
dures and sterilization equipment. At one facility a 30-
minute delay between opening the chamber door and unloading
the chamber was instituted. At the second facility (which
has also conducted monitoring of the workplace and storage
areas using an infrared gas analyzer) a 15-minute air wash
(with the chamber door open) was implemented. The other two
facilities using the NIOSH method have not made changes to
their ETO sterilization operations, but did report obtaining
ETO levels of 1.6 ppm and 0.29 ppm as an 8-hour Time Weighted
Average, respectively.
m- Five of these facilities reported that they had performed
monitoring of the workplace and that ETO concentrations were
determined to be "safe" or within the OSHA standard of 50 ppm
(8-hour Time Weighted Average).
*This method involves adsorption of the ETO on charcoal collection
tubes, and gas chromatographic determination of ETO levels following
desorption with carbon disulfide (Glaser 1977).
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6.11 Cosmetics Industries
6.11.1 Use of ETO By the Cosmetics Industry
Fumigation with ETO is the most frequently used method for
reducing microbial levels in a wide variety of cosmetic ingredients
and hardware items. The widespread use of ETO is a recent develop-
ment. Since 1970, ETO treatment has increased in response to concern
expressed by the U.S. Food and Drug Administration (FDA) regarding
the health hazard potential of contaminated cosmetic products
(Butcher and Goldgraben 1980).
In Preliminary Benefits Analysis of Ethylene Oxide in the Cos-
metics Industry (Butcher and Goldgraben 1980), MITRE reported that
ETO treatment of cosmetic products is performed almost exclusively by
contract sterilizers. Micro-Biotrol Company, a Division of Griffith
Laboratories, fumigates 80 to 84 percent of the cosmetic raw materi-
als and 100 percent of the hardware items used by the cosmetics
industry (Butcher and Goldgraben, 1980). Micro-Biotrol Company was
contacted and requested to supply additional information on its ETO
cosmetics fumigation operations for this report. The information
supplied by Micro-Biotrol regarding measures implemented to control
and monitor worker exposure to ETO at Its five ETO treatment facili-
ties is detailed in Appendic C (Table C-ll) and discussed below.*
*This information, with the exception of data on the size of ETO
sterilizers and the total number of operators, was reported to be
applicable to all of the five facilities operated by Micro-Biotrol.
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6.11.2 Situations Associated with Potential Worker Exposure
The only situation associated with potential worker exposure to
ETO occurs when the sterilizer operators enter the sterilizer to
retrieve ETO-treated materials; however, the degree and duration of
this potential exposure may be minimal due to the material handling
equipment used to remove the treated materials from the chamber and
the equipment and workplace design control measures instituted at
these facilities.
6.11.3 Control Measures
Sterilizer operators at Micro-Biotrol use ETO sterilization
equipment designed with certain engineering features, work in areas
with proper workplace designs, and follow work practices to control
worker exposure to ETO.
• Chambers at Micro-Biotrol facilities are equipped to create
multiple post-vacuums at the end of the sterilization cycle.
One vacuum is typically employed; however, a second full
vacuum is created prior to opening of the chamber door if at
least one hour has elapsed since the completion of the
sterilization cycle.
• The chamber circulation systems have been modified to operate
during chamber unloading to facilitate dilution of residual
ETO in the rear of the chamber where air circulation may be
normally limited.
• Liquid/gas separators are installed in the chamber vent
system to reduce the amount of ETO which is released at the
drain during the exhaust phase of the sterilization cycle.
• Ventilation of the workplace is accomplished through various
techniques at these facilities. Mechanical ventilation
(fans) is used to direct the airflow towards the ETO work
area from non-ETO areas and fans located above each chamber
are used to direct airflow away from the worker and facili-
tate dispersion of the ETO as it escapes from the chamber.
6-34
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In addition, the storage rooms (aeration areas) are equipped
with air circulation systems in which fresh air is introduced
at the ceiling level and vented at the floor level.
• Access to the ETO sterilization area at each facility is
restricted to authorized personnel.
• Operators receive a three month in-house training program on
ETO procedures, instruction in hazard identification, and
procedures to be followed in emergency situations.
• Sterilizer operators leave the chamber door open for at least
five minutes before unloading the ETO-treated materials.
• Operators use battery powered transports or hand pallet
movers to transfer pallets (containing treated materials)
from the sterilizer to specially designated aeration areas in
the facility.
• ETO sterilization equipment is serviced twice annually by
in-house personnel. In addition, Micro-Biotrol has insti-
tuted a system of record-keeping for inspection and
maintenance.
6.11.A Monitoring
Micro-Biotrol has performed monitoring using a Wilks-Miran 101
Gas Analyzer and a gas chromatograph (presumably in conjunction with
personnel monitoring samples). Based on this monitoring, Micro-
Biotrol reported that its workers were exposed to less than 50 ppm,
as an 8-hour time-weighted average. Additional information was not
reported.
6.12 Dairy Packaging Industry
The dairy packaging industry uses ETO to sterilize only those
packages that are required for long shelf-life dairy products, such
as coffee cream, whipping cream, or half and half, to prevent contam-
ination of the dairy product. Presterilization of the packaging
6-35
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materials for these ultrapasteurized dairy products extends the
shelf-life of those products from less than 10 days to between 45 and
60 days (Smith 1980a).
ETO sterilization of packaging materials is not within the nor-
mal operating practices of most dairies or paperboard manufacturers;
therefore, these materials are, with few exceptions, treated by con-
tract sterilizers (Johnson 1980). Approximately 77 percent of these
sterilized packaging materials are treated by Micro-Blotrol Company
(Smith 1980b).
Micro-Biotrol sterilizes these dairy packaging materials in the
same facilities that sterilize cosmetic raw materials and hardware
items (Smith 1980a); therefore, the measures used by Micro-Biotrol to
control and monitor worker exposure to ETO are the same for dairy
packaging materials as they are for cosmetic raw materials and hard-
ware items. This information is discussed in Section 6.11 above and
detailed in Appendix C (Table C-ll).
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7.0 CONCLUSIONS
• ETO sterilization/fumigation is most typically conducted in
a vacuum chamber in which a vacuum system is used to remove
a portion of the ETO present in the chamber prior to the
conclusion of the treatment cycle. Such chambers are the
most common type of equipment in use at 10 of the 12 sites
of interest.
• Information regarding sources and extent of worker exposure
is primarily derived from hospital facilities using vacuum
chambers. Little information is currently available regard-
ing worker exposure at other sites and at facilities in which
other types of containment equipment are used.
• Three categories of workers may be exposed to ETO: chamber
operators, maintenance personnel, and other workers stationed
in the general vicinity of the ETO treatment operation.
Chamber operators may be exposed to ETO while unloading the
chamber and in the course of handling treated goods; main-
tenance personnel may be exposed while performing routine
operations such as replacing emptied sterilant cylinders or,
less frequently, while performing repair work resulting from
equipment breakdown or system malfunction. ETO released
from these exposure events as well as ETO releases from other
sources such as leaks may also result in passive exposure to
these and other workers who are not directly involved in the
treatment process.
• Patterns of worker exposure to ETO are characterized by short
periods of exposure to relatively high concentrations of
ETO; however, available information for both hospital and
industrial users indicates that 8-hour time-weighted average
exposures are typically at or below current OSHA standards
(50 ppm TWA).
• Worker exposure to ETO can be reduced to levels substantially
below current OSHA standards by the implementation of cur-
rently available control measures.
• Measures currently available to reduce worker exposure gen-
erally follow accepted industrial hygiene practices. Such
measures include engineering modifications to the equipment
intended to prevent or minimize ETO releases to the work-
place, workplace design considerations intended to dilute
or remove ETO once released and to isolate sources of expo-
sure, and work practices intended to minimize the duration of
worker exposure and, in some instances, to isolate the worker
from exposure sources.
7-1
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• Manufacturers of sterilization equipment have developed engi-
neering modifications to control and minimize ETO release.
To date, the primary focus has been directed towards improv-
ing the effectiveness of chamber evacuation systems, par-
ticularly for small and intermediate sized chambers. While
several alternative approaches have been developed, the con-
tinuous purge feature offered by 3M appears to be the most
effective method as it substantially reduces both the amount
of ETO released when the chamber door is initially opened
and the amount subsequently offgassed from treated goods.
This approach, in effect, permits preliminary aeration to be
conducted in the sterilization chamber.
• Engineering controls for large industrial chambers have
primarily been directed at methods of ventilating the chamber
after the door is opened by forcing air from the workplace
into and through the chamber. This serves to minimize the
extent of ETO release to the workplace and, when operated
during the unloading process, provides sufficient airflow
over the operator to control exposure to offgassing ETO.
• Utilization of a local exhaust system appears to be the most
generally applicable control measure, as it may be used to
control a number of discrete sources of ETO release, both
routine and non-routine.
• Health care and industrial ETO users (including contract
sterilizers and the medical products, spices, cosmetics,
and dairy packaging industries) have been most likely to
implement control measures. In addition, some industrial
users have been instrumental in developing innovative engi-
neering controls. ETO users at other site have made little
effort to assess and control worker exposure to ETO due, in
part, to limited information regarding the potential health
effects associated with such exposure. Many ETO users at
"minor" sites (including libraries, museums, research lab-
oratories, the beekeeping industry, and high containment
research laboratories) have reported that they were unaware
of any health hazards associated with ETO use. Where con-
trol measures have been implemented, these were instituted
primarily for other purposes and incidentally serve to con-
trol worker exposure to ETO.
• Some ETO users have implemented controls sufficient to comply
with current OSHA standards for worker exposure may be post-
poning implementation of additional measures in anticipation
of downward revision of these standards.
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8.0 REFERENCES
AAMI (Association for the Advancement of Medical Instrumentation),
1980. Good Hospital Practice; Ethylene Oxide Gas Ventilation Recom-
mendations and Safe Use (Proposed). Association for the Advancement
of Medical Instrumentation, Arlington, Virginia.
Abrahams, R., 1980. Director of Regulatory Compliance Division,
American Hospital Supply Corporation, Chicago, Illinois. Personal
Communicat ion.
Ackert, G., 1980. Senior Technical Service Engineer, Medical Prod-
ucts Laboratory, Medical Products Division, 3M Corporation, St. Paul,
Minnesota. Personal Communication.
Alguire, Donald E., 1979, 1980. President, Micro-Biotrol Company,
Alsip, Illinois. Personal Communication.
Allman, C., 1980. Manager, Sensor Development, Rexnord Gas Detection
Products, Sunnyvale, California. Personal Communication.
Amato, Duane, 1980. "Sampling Industrial Environments." Paper
presented at HIMA symposium, Safe Use of Ethylene Oxide. Arlington,
Virginia. June.
AMSCO, 1964. "AMSCO Mattress and Bedding Disinfector with Special
Loading Car." Product Bulletin SC-306R. American Sterilizer
Company, Erie, Pennsylvania.
AMSCO, 1979. "ETO Gas Sterilization Systems." Product Bulletin
ES-2004. American Sterilizer Company, Erie, Pennsylvania.
AMSCO, 1980. "AMSCO-PORTAGAS® Ethylene Oxide Gas Sterilizer."
Technical Data Bulletin SD-115R4. American Sterilizer Company, Erie,
Pennsylvania.
Andersen, S.R., 1978. "Environmental Ethylene Oxide Analysis AN-74
Anprolene Sterilizer." H.W. Andersen Products, Inc., Oyster Bay, New
York.
Andersen. S.R., 1980. "Ethylene Oxide Sterilization: The
STERIJET System." H.W. Andersen Products, Inc., Oyster Bay, New
York.
H.W. Andersen Products, Undated a. "Abridged Illustrated Instruc-
tions for Using Anprolene Gas Ampules." Publication 33519 P/N 706.
H.W. Andersen Products, Inc., Oyster Bay, New York.
8-1
-------
H.W. Andersen Products, undated b. "AN-77 Anprolene Ventilation
Hood." Publication P/N 940 34633. H.W. Andersen Products, Inc.,
Oyster Bay, New York.
Arch, C., 1980. President, Commercial Fumigators, Lake Hopatcong,
New Jersey. Personal Communication.
Arch, R.W., 1980. President, Archway Fumigators, Lake Hopatcong, New
Jersey. Personal Communication.
Archer, E., 1978; 1979; 1980. Director and Chief Conservator,
Lincoln Memorial University, Harrogate, Tennessee, Personal
Communication.
Bach, J.C., 1980. Chief Apiary Inspector, Plant Industry Division,
Washington State Department of Agriculture, Yakima, Washington.
Personal Communication.
Bacharach Instrument Company, 1977. "Instruction Manual TLV
Sniffer." Publication No. 0023-9613. Bacharach Instrument Company,
Mountain View, California.
Bentley, A., 1978; 1979; 1980. Conservator, Massachusetts Historical
Society, Boston, Massachusetts. Personal Communication.
Ben Venue Laboratories, undated. "This is the Ben Venue Sterilizer."
Description and Operating Instructions. Ben Venue Laboratories,
Inc., Bedford, Ohio.
Berger, J., 1980. President, Industrial Fumigators, Maspeth, New
York. Personal Communication.
Bolte, 1980. Veterinary Resources Branch, National Institutes of
Health, Bethesda, Maryland. Personal Communication.
Bourgeois, R., 1980. Owner, Mr. B. Pest Control, New Orleans,
Louisiana. Personal Communication.
Bowman, P.M., 1980. Apiary Inspector, Delaware Department of Agri-
culture, Dover, Delaware. Personal Communication.
Brown, G., 1979; 1980. Conservator, Lowie Museum of Anthropology,
Berkeley, California. Personal Communication.
Brubaker, R., 1978; 1980. Chief Librarian, Chicago Historical
Society, Chicago, Illinois. Personal Communication.
Bruyer, W., 1978. "Engineering Division Test and Evaluation Report."
No. 78009 Castle-Sybron Corporation, Rochester, New York.
8-2
-------
Bruyer, W., 1979a. "Engineering Division Test and Evaluation Re-
port." No. 79016. Castle-Sybron Corporation, Rochester, New York.
Bruyer, W., 1979b. "Engineering Division Test and Evaluation
Report." No. 79023. Castle-Sybron Corporation, Rochester, New York.
Burns, Thomas F., 1980. Executive Vice President, American Spice
Trade Association. Englewood Cliffs, New Jersey. Personal
Communication.
Butcher, A. and R. Goldgraben, 1980. Preliminary Benefits Analysis
of Ethylene Oxide in the Cosmetics Industry. MTR-80W93. The MITRE
Corporation, McLean, Virginia.
Calahan, C., 1979; 1980. Fumigation Chamber Operator, Museum of His-
tory and Technology, Smithsonian Institution, Washington, D. C.
Personal Communication.
Canellos, G., 1980. Preliminary Benefits Analysis of Ethylene Oxide
as a Fumigant in Museums. MTR-79W00294. The MITRE Corporation,
McLean, Virginia.
Canellos, G., N. Parker, S. Russell, and N. Zank, 1980. Preliminary
Benefits Analysis of Ethylene Oxide at Transportation Sites^ MTR-
79W00310. The MITRE Corporation, McLean, Virginia.
Castle-Sybron, 1979. "Castle 1550 Aerator Data Sheet" Publication
2550 (D1550) 70879. Castle-Sybron Corporation, Rochester, New York.
Castle-Sybron, 1980a. "Ethylene Oxide Systems Safeguard." Publica-
tion 2890(971-1710)80580. Castle-Sybron Corporation, Rochester, New
York.
Castle-Sybron, 1980b. "Castle 1500 EO Gas Sterilizer Data Sheet."
Publication 2550 (D1500)180480. Castle-Sybron Corporation,
Rochester, New York.
Century Systems Corporation, undated. "Monitoring and Analysis of
Ethylene Oxide in Air." Application/Tech Note CT-12-80208. Century
Systems Corporation, Arkansas City, Arkansas.
Chamberlain, R., 1980. Industrial Engineering Division, American
Sterilizer Company, Erie, Pennsylvania. Personal Communication.
Chiotakis, A.V., 1980. Greenhouse Manager, Pesticides and Plant
Protection Division, North Carolina Department of Agriculture,
Raleigh, North Carolina. Personal Communication.
8-3
-------
Clark, L., 1979; 1980. Director, Restoration and Preservation, Maine
State Archives, Augusta, Maine. Personal Communication.
George D, Clayton and Associates, 1973. "Design of Ventilation Sys-
tem." The Industrial Environment - Its Evaluation and Control. U.S.
Department of Health, Education and Welfare, Government Printing Of-
fice, Washington, D.C.
Cole, A.E., 1980. Director, Plant Pest Control Division, West
Virginia Department of Agriculture, Charleston, West Virginia.
Personal Communication.
Corn, R., 1980. Sterilization Supervisor, The University of Arizona,
Health Sciences Center, Tucson, Arizona. Letter of 17 September
1980.
Curtis, J., 1979; 1980. Director, Curational Department, Old
Sturbridge Village, Sturbridge, Massachusetts. Personal Communi-
cation.
Daley, W., W. Morse, and T. Ridgway, 1979. Ethylene Oxide Control in
Hospitals. American Hospital Association, Chicago, Illinois.
D'Aquila, J., 1980. Vice President-Marketing, Environmental Tec-
tonics Corporation, Southhampton, Pennsylvania. Personal Communi-
cation.
Davis, T., 1980. Manager, Animal Production Facility, Frederick Can-
cer Research Center, Frederick, Maryland. Personal Communication.
Donkin, T., 1980. Vice President-Operations. Enmet Corporation, Ann
Arbor, Michigan. Personal Communication.
Downey, J., 1980. Inside Sales Manager, HNu Systems, Inc., Newton,
Massachusetts. Personal Communication.
ECRI (Emergency Care Research Institute), 1975. "Evaluation:
Ethylene Oxide Sterilizers." Health Devices 5(2):27-49.
Edick, K., 1980. Project Engineer, Vernitron Medical Products,
Carlstadt, New Jersey. Personal Communication.
Eliades, G.K., 1980. President, Society of American Wood Preservers,
Inc. Arlington, Virginia. Presentation of wood treatment processes
to MITRE staff, January 28, 1980.
Farmer, N.E., 1980. ETO Chamber Operator for Connecticut, Bristol,
Connecticut. Personal Communication.
8-4
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Fellippelli, R., 1980. Pennsylvania State University, Pattee
Library, University Park, Pennsylvania. Personal Communication.
Fitch, R., 1980. Plant Manager, Charles River Associates,
Wilmington, Massachusetts. Personal Communication.
Fleming, J., 1980. Sales Manager, National Draeger, Inc.,
Pittsburgh, Pennsylvania. Personal Communication.
Foxboro Company, 1979. "Wilks Miran Portable Ambient Air Analy-
zers." Technical Brochure. The Foxboro Company, South Norwalk,
Connecticut.
Frechette, J.R., 1980. Manager, Service Training, Sybron Corpora-
tion, Medical Products Division, Rochester. New York. Personal
Communication*
Freitag, D., 1980. Conservation Department, Harvard University,
Cambridge, Massachusetts. Personal Communication.
Gardner, D., 1980. Vice President of Technical Services, Surgicot
Company, Smithtown, New York. Personal Communication.
Gear, J., 1978; 1980. Chief, Preservation Services Division,
National Archives, Washington, D. C. Personal Communication,
Gervasoni, R.A., 1980. Engineer Entomology Supervisor, United States
Air Force, McGuire Air Force Base, Ricetown, New Jersey. Personal
Communication.
Glaser, Z., 1977. Special Occupational Hazard Review and Control
Recommendations for the Use of Ethylene Oxide as a Sterilant in
Medical Facilities. National Institute for Occupational Safety and
Health, Washington, D.C.
Glaser, Z., R. Gruyer, G. Mallison, L. Valcovic, E. Weisburger, and
H. Falk, 1977. Report of the Subcommittee on the Benefits and Risks
from the Use of Ethylene Oxide for Sterilization. Department of
Health, Education and Welfare, Washington, D.C.
Goldgraben, R., 1980. Preliminary Benefits Analysis of Ethylene
Oxide as a Fumigant in Libraries. MTR-79W00221. The MITRE Corpora-
tion, McLean, Virginia.
Green, J.F., 1980. State Apiarist, Pesticides and Plant Protection
Division, North Carolina Department of Agriculture, Raleigh, North
Carolina. Personal Communication.
8-5
-------
Griffith, R., 1979. Campus Pest Control, University of California at
Los Angeles, Los Angeles, California. Personal Communication.
Gunther, D.A,, 1970. "Evaluation of Equipment, Techniques for Indus-
trial Ethylene Oxide Sterilization." American Perfumes and Cosmetics
85(3):35-38.
Gunther, D.A., 1980. Engineer, American Sterilizer Company, Erie,
Pennsylvania. Personal Communication.
Hall, T., 1980. Safety Department, Frederick Cancer Research Center,
Frederick, Maryland. Personal Communication.
Hamlin, J,, 1980a. Sales Manager, H.W. Andersen Products Inc.,
Oyster Bay, New York. Personal Communication.
Hamlin, J., 1980b. Sales Manager, H.W. Andersen Products Inc.,
Oyster Bay, New York. Letter of 1 July 1980.
Hanel, E., 1979; 1980. Frederick Cancer Research Center, Frederick,
Maryland. Personal Communication.
Hart, T., 1980. Apiary Administrator, Tennessee Department of Agri-
culture, Nashville, Tennessee. Personal Communication.
Havel, K.D., 1980. Chairman, Ethylene Oxide Assessment Team and Cen-
ter Director, Hoboken Methods Development Center, Plant Protection
and Quarantine Program, U.S. Department of Agriculture, Hoboken, New
Jersey. Personal Communication.
HIMA (Health Industry Manufacturers Association), 1979. 1979 Annual
Report of the Health Industry Manufacturers Association. Health
Industry Manufacturers Association, Washington, D.C.
Hoffman, P., 1978; 1979; 1980. Head, Archives Branch, North Carolina
Archives and Record Section, Raleigh, North Carolina. Personal
Communication.
Hohler, J., 1978; 1980. Preservation Official, Wisconsin State
Historical Society, Madison, Wisconsin. Personal Communication.
Houben, W., 1979. "Continuous Monitoring of Ethylene Oxide (EtO)
in Sterilizers by NDIR." Technical Information Bulletin. Beckman
Instruments, Inc., Process Instruments Division, Fullerton,
California.
Irish, Kent, 1980. Plant Pathologist, Plant Disease Research Labora-
tory, Fort Detrick, Frederick, Maryland. Personal Communication.
8-6
-------
Isbill, M.B., 1980. Technical Advisor, D.A. Exterminating Company,
Marine Division, Metairie, Louisiana. Personal Communication.
James, H. 1980. Chief Technician, Allergy and Infectious Disease
Institute, National Institutes of Health, Bethesda, Maryland.
Personal Communication.
Jernigan, J.L. 1980. Manager, Western Termite and Pest Control,
Dover, Delaware. Personal Communication.
Johnson, S., 1980. Director, Government Relations, Paperboard Pack-
aging Council, Washington, D. C. Personal Communication.
Jorkasky, James, 1980. Technical Assistant, Health Industry Manu-
facturers Association, Washington, D. C. Personal Communication.
Keating, R., 1980. State Entomologist, Division of Insect and Plant
Disease Suppression and Control, New Hampshire Department of Agricul-
ture, Durham, New Hampshire. Personal Communication.
Keenan, R., 1973. "Direct Reading Instruments for Determining Con-
centrations of Aerosols, Gases and Vapors." The Industrial Envi-
ronment; Its Evaluation and Control. U.S. Department of Health,
Education and Welfare, Washington, D.C. Government Printing Office.
Knox, D.A., 1980. Bioenvironmental Bee Laboratory, Plant Protection
Institute, Agricultural Research Service, United States Department of
Agriculture, Beltsville, Maryland, Personal Communication.
Koketsu, M., Z.R. Glaser and L. Carssow, 1977. "Environmental Field
Study Results of the Use of Ethylene Oxide for Sterilization of
Equipment in Medical Facilities." (Unpublished). Division of Cri-
teria Documentation and Standards Development, National Institute for
Occupational Safety and Health, Rockville, Maryland.
Kolbe, W., 1980. Training Coordinator, Western Termite and Pest
Control, West Orange, New Jersey. Personal Communication.
Krell, J., 1980. Technical Representative, International Sensor
Technology, Santa Ana, California. Personal Communication.
Kreyling, S., 1980. Chief Engineer, Vernitron Medical Products,
Carlstadt, New Jersey. Personal Communication.
3M Company, 1978. Operator's Manual, Model 400B Gas Sterilizer.
Medical Products Division, 3M Company, St. Paul, Minnesota.
8-7
-------
3M Company, 1979. Infection Control Rounds 3(1);1, 4-16 3M Company,
Medical Products Division, St. Paul, Minnesota.
Mack, J., 1980. Market Development Supervisor, Infection Control
Systems, Medical Products Division, 3M Company, St. Paul, Minnesota.
Personal Communication.
Mann, L. Arnold, 1980. Manager of Product Development and Quality
Assurance, Cheshire Laboratories, Piscataway, New Jersey. Personal
Communication.
Markinson, H., 1980a. Sales Manager, Vacudyne-Altair Corporation,
Chicago Heights, Illinois. Personal Communication.
Markinson, H., 1980b. "Sterilizer Design and Maintenance." Paper
presented at HIMA Symposium, Safe Use of Ethylene Oxide, Arlington,
Virginia. June.
Marsh, Cleveland, 1979. Economic Analysis of Ethylene Oxide Use on
Stored Products. Griffith Laboratories, Alsip, Illinois.
Matthenius, J.C., 1980. Apiculturist, New Jersey Deparment of Agri-
culture, Trenton, New Jersey. Personal Communication.
McComb, 1980. Chemist, Library of Congress, Washington, D. C.
Personal Communication.
McDermott, K., 1980. Engineering Department, Bacharach Instrument
Co., Mountain View, California. Personal Communication.
McKenzie, G., 1979. On Board Services, Amtrak, Washington, D. C.
Personal Communication.
Melanson, L., 1980. President, Amdek Corp., Hudson, Massachusetts.
Personal Communication.
Miskoe, I.W., 1980. Owner, Miskoe Engineering, Concord, New Hamp-
shire. Personal Communication.
Morgan, S.L., 1980a. Vice President, Ben Venue Laboratories, Bed-
ford, Ohio. Personal Communication.
Morgan, S.L., 1980b. Vice President, Ben Venue Laboratories, Bed-
ford, Ohio. Letter of 7 July 1980.
Morris, N., 1980. Chemist, Century Systems Corporation, Arkansas.
City, Kansas. Personal Communication.
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-------
Mumma, H., 1980. Officer in Charge of Plant Protection and Quaran-
tine Program at McGuire Air Force Base, Plant Protection and Quaran-
tine Program, U.S. Department of Agriculture, Ricetown, New Jersey.
Personal Communication.
Mutchler, J., 1973a. "Local Exhaust System." The Industrial Environ-
ment-Its Evaluation and Control. U.S. Department of Health, Edu-
cation and Welfare, Government Printing Office, Washington, D.C.
Mutchler, J.,1973b. "Principles of Ventilation." The Industrial
Environment-Its Evaluation and Control. U.S. Department of Health
Education and Welfare, Government Printing Office, Washington, D.C.
Myers, David, 1979; 1980. Assistant Director for Health, The Jackson
Laboratory, Bar Harbour, Maine. Personal Communication.
Newton, D. C., 1980. Department of Biological Sciences, Central
Connecticut State College, New Britain, Connecticut. Personal
Communication.
NIOSH (National Institute for Occupational Safety and Health), 1976.
NIOSH Analytical Methods for Set T. Cincinnati, Ohio.
Nusbaum, R., 1980a. "Design of Ventilation Devices-Suggestions for
Ventilation of 12/88 Ethylene Oxide Sterilizers in Industrial Facili-
ties." Paper presented at HIMA Symposium, Safe Use of Ethylene
Oxide, Arlington, Virginia. June.
Nusbaum, R., 1980b. President, Pennsylvania Engineering Company,
Philadelphia, Pennsylvania. Personal Communication.
Ogden, S., 1979;1980. Book Conservator, New England Document Conser-
vation Center, Massachusetts. Personal Communication.
Opp, C., 1980. "Monitoring Ethylene Oxide with Direct Reading
Instrumentation." Paper presented at HIMA symposium, Safe Use of
Ethylene Oxide, Arlington, Virginia. June.
Organ, R., 1980. Director, Conservation Analytical Laboratory,
Museum of Histroy and Technology, Smithsonian Institution,
Washington, D. C. Personal Communciation.
Osborne, A., 1979; 1980. Assistant Curator, Museum of Our National
Heritage, Lexington, Massachusetts. Personal Communication.
Palm, C., 1980. Deputy Archivist, Herbert Hoover Institute. Stan-
ford, California. Personal Communication.
8-9
-------
Paloko, J., 1979. Service Representative, Orkin Pest Control,
Chicago, Illinois. Personal Communication.
Pellissier, R., 1980. Sales Applications Engineer, Gastech Inc.,
Mountain View, California. Letter of 1 October 1980.
Perry, J., 1950. Chemical Engineers Handbook. 3rd Edition. McGraw
Hill Book Company, New York, New York.
Phillips, G.B., H. Holstein, and L. Worden, 1978. HIMA Report 78-3,
Ethylene Oxide Technical Report, 1978 Submission to the Environmental
Protection Agency. Health Industry Manufacturers Association,
Washington, D.C.
Phillips, G. B., 1980. Vice President, Scientific and Technical
Affairs, Health Industry Manufacturers Association, Washington, D. C.
Personal Communication.
Pierce, H., 1980. National Museum of Natural History, Smithsonian
Institution, Washington, D. C. Personal Communication.
Plante, Steve, 1980. General Manager, Med-Surg Industries, Inc.
Rockville, Maryland. Personal Communication.
Port, R., 1980. Owner, Port's Bee Supplies and Control; Operator,
Miskoe chamber for State of Oregon, Milwaukee, Oregon. Personal
Communication.
Powers, H.P., 1980. State Apiarist, Virginia Department of Agricul-
ture, Richmond, Virginia. Personal Communication.
Prall, G.M., 1980. Officer in Charge of the Port of Baltimore, Plant
Protection and Quarantine Program, U.S. Department of Agriculture,
Baltimore, Maryland. Personal Communication,
Qazi, A. and N. Ketcham, 1977. "A New Method for Monitoring Personal
Exposure to Ethylene Oxide in the Occupational Environment."
American Industrial Hygiene Association Journal 38(11):635-647.
Radden, E., 1980. Safety and Health Department, National Institutes
of Health, Bethesda, Maryland. Personal Communication.
Randall, F., 1980. State Apiary Inspector, Alabama Department of
Agriculture, Montgomery, Alabama. Personal Communication.
Raskosky, J., 1980. Cargo Agent and Fumigator, Port Authority Fumi-
gations, Port Newark, New Jersey. Personal Communication.
8-10
-------
Reilly, G., 1979; 1980. Director, Conservation Service. Winterthur
Museum, Winterthur, Delaware. Personal Communication.
Richmond, John, 1980. Safety Officer, Plum Island Animal Disease
Center. Greenport, New York. Personal Communication.
Romano, S.J. and J.A. Renner, 1979. "Analysis of Ethylene Oxide -
Worker Exposure." American Industrial Hygiene Association Journal
40(8):742-745.
Roy, P.A., 1980a. "Engineering Control of ETO Exposures from Gas
Sterilization." Paper presented at HIMA Symposium on Safe Use of
Ethylene Oxide, Arlington, Virginia.
Roy, P.A., 1980b. Senior Industrial Hygienist, Medtronic Inc.,
Fridley, Minnesota. Personal Communication.
Roy, P.A., 1980c. "Gas Sterilization Exposure Control." Medtronic
Inc., Fridley, Minnesota.
Ruck, D. 1978. "Design Flaw Blamed for EO Gas Leakage: Thousands of
Hospitals May Be Affected" American Medical News 21(28):11.
Runnells, Glenn, 1980. Staff Specialist, American Hospital Associa-
tion, Chicago, Illinois. Personal Communication.
Russell, G., 1980. Fumigation Chamber Operator, National Museum of
Natural History, Smithsonian Institution. Washington, D. C.
Personal Communication.
Samuels, T., 1978. "Personnel Exposures to Ethylene Oxide In a
Central Service Assembly and Sterilization Area." Hospital Topics.
May/June 1978: 27-33.
Samuels, T. and R. Corn, 1979a. "Reduce Operator Exposure and Envi-
ronmental Levels of Ethylene Oxide. Utilization of a Unique Local
Exhaust on a Small ETO Sterilizer." Hospital Topics 57(5):48-54.
Samuels, T. and R. Corn, 1979b. "Modification of Large, Built-in,
Ethylene Oxide Sterilizers to Reduce Operator Exposure to E0."
Hospital Topics 57(6):50-55.
Samuels, T. and R. Corn, 1980. "Evaluation of a New Generation
Ethylene Oxide Sterilizer Relative to Reduction in Operator Exposure
to ETO." Hospital Topics 58(1):31-36.
Samuels, T. and M. Eastin, 1980. "ETO Exposure Can Be Reduced by Air
Systems." Hospitals, July 1:66-68.
8-11
-------
Sax, N.I., 1979. Dangerous Properties of Industrial Materials.
Fifth Edition. Van Nostrand Reinhold Company. New York, New York.
Schmelz, Dennis, 1980. Facility Manager, Sterilization Services of
Georgia. Atlanta, Georgia. Personal Communication.
Schulte, H. 1973. "Personal Protective Devices." The Industrial En-
vironment - Its Evaluation and Control. U.S. Department of Health,
Education and Welfare, Government Printing Office, Washington, D. C.
Scott, J., 1980. Service Department, Advanced Instruments, Inc.,
Needham Heights, Massachusetts. Personal Communication.
Scotti, J., 1980. Manager, Port Warehouse Fumigators, New York, New
York. Personal Communication.
Shelley, J., 1978; 1979; 1980. Archivist, Pennsylvania State Ar-
chives, Harrisburg, Pennsylvania. Personal Communication.
Shimanuki, H., 1980. Bioenvironmental Bee Laboratory, Scientific and
Education Administration, U.S. Department of Agriculture, Beltsville,
Maryland. Personal Communication.
Shlisky, T., 1980. Engineering Consultant, Scientific Industries,
Inc., Bohemia, New York. Personal Communication.
Sias, R., 1980. Production Manager, Beverly Pacific Corporation,
Burbank, California. Personal Communication.
SKC, Inc., 1980. "1980 Catalog and Guide to Air Sampling Standards."
Eighty Four, Pennsylvania.
Skocypec, R. 1980. Manager of Technical Service, Vacudyne-Altair,
Chicago Heights, Illinois. Personal Communication.
Slater, G., 1979. Director of Marketing, Charles River Associates,
Wilmington, Massachusetts. Personal Communication.
Smith, C., 1980* California Department of Agriculture, Scaramento,
California. Personal Communication.
Smith, Myra, 1980a. "Memorandum: Status of Use Profiles and Alter-
natives Assessment for Ethylene Oxide Sterilization of Dairy Pack-
aging Materials." U.S. Environmental Protection Agency, Washington,
D. C.
Smith, Myra, 1980b. "Draft Report on ETO Sterilization of Dairy
Products." U.S. Environmental Protection Agency, Washington, D.C.
3-12
-------
Spoden, J. 1980. Sterilizer Products Manager, American Sterilizer
Company, Erie, Pennsylvania. Personal Communication.
Spucci, P., 1980. Customer Service, American Cystoscope Makers Inc.,
Stamford, Connecticut. Personal Communication.
Stevens, G., 1980. Apiculturist, New York Department of Agriculture
and Markets, Albany, New York. Personal Communication.
Suffin, S., 1980. Laboratory Director, National Institutes of
Health, Bethesda, Maryland. Personal Communication.
Sullivan, James F., 1980. Safety Officer, National Animal Disease
Center, Ames, Iowa. Personal Communication.
Tilly, W. A., 1980. Chairman of the Board, Home Exterminating Com-
pany, Baltimore, Maryland. Personal Communication.
Turner, D., 1980. Assistant Administrator, Commodities and Inspec-
tion Division, Oregon Department of Agriculture, Salem, Oregon.
Personal Communication.
USDA (U.S. Department of Agriculture), 1976. Plant Protection and
Quarantine Programs Treatment Manual, Plant Protection and Quarantine
Programs, U.S. Department of Agriculture, Washington, D.C.
USDA (U.S. Department of Agriculture), 1978. USDA/STATES/EPA Assess-
ment of Ethylene Oxide Uses in Agriculture. Draft Report. U.S.
Department of Agriculture, Washington, D.C.
Vanden Bosche, E., 1980. Apiary Inspector, Plant Protection Section,
Maryland Department of Agriculture, Annapolis, Maryland. Personal
Communication.
Vanderpool, L., 1980. Project Leader of Apiary Inspection,
California Department of Agriculture, Sacramento, California.
Personal Communication.
Vanech, G., 1980. Assistant Area Director of the Port of New York,
Plant Protection and Quarantine Program, U.S. Department of Agricul-
ture, New York, New York. Personal Communication.
Vanell, L., 1980. Market Specialist, Ambient Air Products, Foxboro
Analytical, the Foxboro Company, South Norwalk, Connecticut.
Personal Communication.
Warlow, J. E., 1980. Assistant Officer in Charge of the Port of New
Orleans, Plant Protection and Quarantine Program, U.S. Department of
Agriculture, New Orleans, Louisiana. Personal Communication.
8-13
-------
Weidrich, T., 1978. Guide for the Safe Use of Ethylene Oxide In the
Hospital. Castle-Sybron Corporation, Rochester, New York.
Weidrich, T., 1980. Senior Engineer, Castle-Sybron Corporation,
Castle Medical Products Division, Rochester, New York. Personal
Communication.
Wilson, N.W., 1980. Fumigator, Orkin, Incorporated, New Orleans,
Louisiana. Personal Communication.
Young, J., 1980. Research Director, American Sterilizer Company,
Erie, Pennsylvania. Personal Communication.
Zank, N., G. Canellos, J. Cioffi, 1980. Preliminary Benefits Analy-
sis of Ethylene Oxide as a Sterilant in Research Laboratories, MTR-
79W00265. The MITRE Corporation, McLean, Virginia.
8-14
-------
APPENDIX A
SITE VISITS CONDUCTED
A.-1
-------
APPENDIX A
SITE VISITS CONDUCTED
Site Facility
Health Care Doctor's Hospital of Prince
George's County
Lanham, Maryland
Genessee Hospital
Rochester, New York
Walter Reed Army Medical Center
Washington, D.C.
Medical Products Industry Cheshire Laboratories, Inc.
Plscataway, New Jersey
Med-Surg Industries, Inc.
Rockville, Maryland
Sterilization Services
of Georgia (Vacudyne/Altair)
Atlanta, Georgia
Libraries
Library of Congress
Washington, D.C.
National Archives
Washington, D.C.
Museums
National Museum of History
and Technology
Washington, D.C.
National Museum of Natural
History
Washington, D.C.
Research Laboratories Frederick Cancer Research
Center
Frederick, Maryland
National Institutes of Health
Bethesda, Maryland
A-2
-------
APPENDIX A (CONCLUDED)
Beekeeping Industry
High Containment Research
Laboratories
Animal and Plant Service
Quarantine at Ports of Entry
Equipment Manufacturers
Maryland Department of
Agriculture
Beltsville, Maryland
Plum Island Animal Disease
Center
Greenport, New York
U.S. Department of Agriculture
Dover Air Force Base
Dover, Delaware
American Sterilizer Company
(AMSCO)
Erie, Pennsylvania
Castle-Sybron Corporation
Rochester, New York
3M Corporation
ST. Paul, Minnesota
-------
APPENDIX B
EVALUATION OF WORKER EXPOSURE AND AMBIENT ETO
CONCENTRATIONS AT A HOSPITAL CENTRAL SUPPLY FACILITY
B-l
-------
THE UNIVERSITY OF ARIZONA
HEALTH
TUCSON
SCIENCES
ARIZONA
CENTER
8 5 7 2 4
UNIVERSITY HOSPITAL
PHARMACY A SUPPLY DEPARTMENT
17 September 1980
Reriee Goldgraben
Toxic Substances Control
The MITRE Corporatlon/Metrek Division
1820 Dolley Madison Boulevard
McLean, Virginia 22102
Dear Renee,
I enjoyed meeting and talking with you 1n Denver. Dr. Samuels and I
are very glad to have the opportunity to help you and thus to help
the EPA In data gathering.
Enclosed please find more Information about our two major studies on
ethylene oxide control. I didn't locate all that we had done, but I
have Included what I could find that wasn't 1n the published material.
The pages are divided into two sections. A brief explanation of the
enclosed material may help you, so here goes.
The first study 1n 1978 was to look at the existing situation here
and see what could be done to Improve 1t. Page 1 shows the existing
air flow and p.2 shows how 1t 1s affected by the sterilizers. Page 3
shows how the room was"d1vlded" Into 10 sections for area monitor
sampling. The large aeration cabinet was monitored near the exhaust
vent and the results are on p.4. A cold cycle was monitored (p.5)
and another "process sample" was taken (p.6) before we began the area
sampling. Each grid was monitored for a full day with events noted.
Pages 7-18 show the results of this monitoring with the m1nute-by-
mlnute readings. Pages 19-25 show several of these grids plotted out.
I couldn't find the others. A summary with the 8-hour TWA for each
grid 1s on p.26.
The second study 1n 1979 was designed to exa«1ne the effects of local
exhaust hoods (3M - models 200 & 400B), cycle purge modifications
(Castle), and new sterilizer Improvements (3M - M400B). Data was
collected from the locations shown on p. 27. Charcoal tubes were
used to collect air samples at the five locations. The loads were
run simultaneously 1n each sterilizer but because of the length of
the cycles they came out about an hour apart. Each test situation
was duplicated and results analyzed for s1l1lar1ty. Results for the
3M model 200 are on pages 28-31, for the 3M 400B on pages 32-35, and
pages 36-39 for the Castle sterilizer. These results with each run
shown are all on p.40 as received from the laboratory. A graph of
the 400B results 1s on p.41. Pages 42-49 show the breakdown of the
infra-red analyzer data collected on the 400B. I couldn't find the
B-2
-------
other two sets. The method used to find the TWA's is shown there
also.
I trust that this material will be helpful to you. I am sure that
when Dr. Samuels returns in October we can send you more data if you
would like.
Thanks again for your interest 1n our work. I hope that we will be
able to do much more in the near future. I look forward to hearing
from you soon.
Randy Corn
Supervisor
Sterilization
B-3
-------
100 FPM
,-3
_~ C_
STERILIZERS
s^LU
20 FPM
20
40 FPM
P
18 FPM
18 FPM
20 FPM
545 CFM
30 FPM
:PM
18 FPM
625 CFM / 345 CFM
50 FPM
35 FPM
507 CFM^N /625 CFM
30 FPM 25 FPMSC^jj
40 FPM
625 CFM
25 FPM
15 FPM
CL
u_
,0'
CO
0611
OPERATION WITH STERILIZER
DOORS CLOSED
B-4
-------
_Z] t=
LOCALIZED AIR
FLOW CHANGE
I I
LIZERS
STERI
V7T, . .HE
'50 FPM 40 FPM
/
U
J
0611
STERILIZER DOORS OPENED
UPON COMPLETION OF CYCLE
B-5
-------
3 C_
(0
r —'
1
STERI
_ .m R , .
i i
LIZERS
1 a L
n I a H 5"
jl
rV A
p c_
X
y
(,
i
2~
J
1
J H
(]
r
3
i n
B-6
-------
LARGE AERATION CABINET VENT
Detector 12 inches from exhaust vent
PREFAN STAGE RANGE 1.5 ppm TO 500 ppm (6 min)
INITIAL SURGE > 1200 ppm
1 MIN 720 PPM
2 MIN 360 PPM
3 MIN 240 PPM
5 MIN 168 PPM
15 MIN 120 PPM
25 MIN 108 PPM
30 MIN 108 PPM
B-7
-------
SMALL STERILIZER
LOAD - Bag of glass syringes - cold cycle
Detector located at breathing zone height; 12 inches
FROM CABINET TO THE LEFT OF THE DOOR,
INITIAL OPENING 385 ppm-
1 MIN 120 PPM
2 MIN 96 PPM
3 MIN 24 PPM
5 MIN 0 PPM
8 MIN 24 PPM (IN AERATION CABINET
possible surge from
cabinet)
B-8
-------
SMALL STERILIZER hiII) SMALL AERATOR
LOCATION: Center of 2 model 200's - 28 inches;
APPROXIMATELY 60 INCHES FROM AERATOR
START: 7:00 am
7:00 am - 0 ppm
9:40 am - 0 ppm (Start cycle #4 & #5)
10:50 am - 5 ppm (Cycle end - door opened)
10:55 am - 600 ppm
10:56 am - 864 ppm
10:57 am - 480 ppm
10:58 am - 220 ppm
10:59 am - 100 ppm
11:00 am - 75 PPM
11:15 AM - 10 PPM
12:00 5 ppm
12:50 PM - 2,5 ppm (Cycle ends, #4 & #5 opened)
12:50 pm - 410 ppm
1:00 pm - 50 ppm
1:01 pm - 625 ppm
1:05 pm - 105 ppm
1:10 pm - 5 ppm
B~9
-------
GRIf i
LANDMARKS: 27 ft from #5
21 FT FROM #2
22 FT FROM LARGE AERATOR
30 FT FROM SMALL AERATOR
29 FT FROM #4
START:
7:15 am
7:15
AM ¦
- 0
PPM
8:05
AM -
- 0
PPM
(#5 OPENED - LEFT CLOSED
OVERNIGHT)
8:08
AM -
- 60
PPM
8:13
AM -
- 75
PPM
8:15
AM -
- 10
PPM
8:18
AM -
- 20
PPM
(item placed in lg aerator)
8:20
AM -
¦ 20
PPM
8:30
AM -
¦ 0
PPM
12:35
PM -
- 30
PPM
(lg cart containing previously
gassed item held in quarantine
MOVED AROUND SENSOR)
12:40
PM -
- 5
PPM
2:50
PM -
¦ 0
PPM
(#4 opened)
2:55
PM -
¦ 5
PPM
3:00
PM -
¦ 0
PPM
3:40
PM -
• 0
PPM
B-10
-------
GRID '
LANDMARKS: 19 ft from #5
10 FT FROM it2
24 FT FROM SMALL AERATOR
15 FT FROM LARGE AERATOR
21 FT FROM #4
START: 4:15 pm
4:20 pm -
0 PPM
4:23 pm -
20 ppm
4:24 pm -
40 ppm
4:25 pm -
30 ppm
4:26 pm -
20 ppm
4:23 pm -
10 PPM
4:30 pm -
0 PPM
10:10 pm -
0 PPM
10:14 pm -
30 ppm
10:15 pm -
250 ppm
10:16 PM -
80 ppm
10:17 pm -
60 ppm
10:18 pm -
40 ppm
10:19 pm -
30 ppm
10:20 pm -
20 ppm
10:21 pm -
15 ppm
10:22 pm -
10 ppm
10:25 pm -
0 PPM
B-ll
-------
GRID 2 (K:EAT)
LANDMARKS: 19 ft from #5
10 ft from #2
24 FT FROM small aerator
IS FT FROM LARGE AERATOR
21 FT FROM #4
START: 7:45 am
8-.00
AM "
0
PPM
10:35
AM -
0
PPM
10:40
AM "
25
PPM
10:41
AM -
45
PPM
10:42
AM -
40
PPM
10:43
AM -
40
PPM
10:44
AM "
25
PPM
10:45
AM -
25
PPM
10:46
AM ~
20
PPM
10:50
AM -
5
PPM
10:55
AM -
0
PPM
4:00
PM . "
0
PPM
4:05
PM -
50
PPM
4:10
PM -
0
PPM
FIRST
SHIFT
B-12
-------
GRID 2 - REPEAT (cont!d)
9:30
PM ¦
0 PPM
9: 3^4
PM •
- 200 PPM
9:35
PM ¦
- 325 ppm
9:36
PM -
- 150 ppm
9:'10
PM -
25 ppm
9:50
PM -
0 ppm
SECOND
SHIFT
J
B-13
-------
GRIP <
LANDMARKS: 22 ft from H5
24 FT FROM #2
20 FT FROM LARGE AERATOR
27 FT FROM SMALL AERATOR
24 FT FROM #4
START
9:40 am
11
28
AM -
0
PPM
11
29
AM -
0
PPM
11
30
AM -
15
PPM
11
31
AM -
30
PPM
11
32
AM -
45
PPM
11
33
AM -
5!")
PPM
11
34
AM -
55
PPM
11
35
AM -
50
PPM
11
36
AM -
50
PPM
11
37
AM -
167
PPM
11
38
AM -
100
PPM
11
39
AM -
85
PPM
11
40
AM ~
70
PPM
11
41
AM "
60
PPM
11
42
AM "
50
PPM
11
43
AM -
40
PPM
11
44
AM -
30
PPM
11
45
AM -
25
PPM
11
46
AM -
25
PPM
11
47
AM -
20
PPM
11
48
AM -
25
PPM
11
49
AM •
20
PPM
11
50
AM *
15
PPM
11
51
AM •
10
PPM
11
55
AM
- 5
PPM
12
00
- 0
PPM
2
20
PM
¦ 0
PPM
2
24
PM
- 0
PPM (#4 & #5
opened)
2:25
PM ¦
- 20
PPM
2:26
Pf1 ¦
- 55
PPM
2:27
PM •
- 60
PPM
2:28
PM *
¦ 25
PPM
2:29
PM ¦
¦ 25
PPM
2:30
PM ¦
• 20
PPM
2:31
PM -
- 20
PPM
2:32
PM ¦
- 15
PPM
2:33
PM *
- 15
PPM
2:34
PM ¦
¦ 10
PPM
2:35
PM •
¦ 10
PPM
2:40
PM •
- 0
PPM
B-14
-------
GRID 4
LANDMARKS: 14 FT from //5
15 FT FROM U2
17 FT FROM SMALL AERATOR
10 FT FROM LARGE AERATOR
16 FT FROM #4
START: 7:15 am
1
35 pm
- 0
PPM
1
39 pm
- 5
PPM
1
40 pm
- 35
PPM
1
41 pm -
- 25
PPM
1
42 pm -
20
PPM
1
43 pm -
15
PPM
1
44 pm -
10
PPM
1
45 pm -
5
PPM
1
46 pm -
0
PPM
B-15
-------
GRIP 1
LANDMARKS: 21 ft from #5
42 ft from #2
22 FT FROM SMALL AERATOR
33 FT FROM LARGE AERATOR
START: 7:20 am
2:05
PM -
0
PPM
(TAKE OUT #4)
2:07
PM -
.10
PPM
2:08
PM -
20
PPM
2:09
PM -
18
PPM
2:10
PM -
10
PPM
2:11
PM -
10
PPM
2:12
PM -
5
PPM
7:13
PM -
0
PPM
3:05
PM -
0
PPM
(HS OUT)
3:07
PM -
5
PPM
3:08
PM -
25
PPM
3:09
PM -
25
PPM
3:10
PM -
20
PPM
3:11
PM -
15
PPM
3:12
PM -
10
PPM
3:13
PM -
5
PPM
3:14
PM -
5
PPM
3:15
PM -
5
PPM
3:20
PM -
0
PPM
B-16
-------
GRID *
LANDMARKS: 9 ft from #5
12 FT FROM SMALL AERATOR
15 FT FROM LARGE AERATOR
11 FT FROM #4
START: 7:25 am
10:50 am -
10:53 am -
10:54 am -
10:55 am -
10:56 am -
10:57 AM -
10:58 am -
0 ppm W opened)
155 ppm
150 ppm
125 ppm
80 ppm
60 ppm
40 ppm
1:01 pm -
1:02 pm -
1:03 pm -
1:04 PM -
1:05 PM -
•1:10 PM -
2:05 pm -
15 PPM
10 ppm
10 PPM
15 PPM
5 PPM
0 PPM
0 ppm (#5
opened)
10:59 am -
25 ppm
2:06 pm -
15 ppm
11:00 am -
15 ppm
2:07 PM -
175 ppm
11:01 am -
15 ppm
2:08 PM -
125 ppm
11:02 am -
10 PPM
2:09 PM -
50 ppm
11:03 am -
10 PPM
2:10 pm -
25 ppm
11:04 am -
0 PPM
2:11 PM -
20 ppm
12:50 pm -
12:55 pm -
0 PPM
0 PPM (#5 opened)
2:12 pm ¦
2:13 pm •
20 ppm
40 ppm
12:56 pm -
0 PPM
2:14 pm
15 ppm
12:57 pm -
70 ppm '
2:15 pm ¦
15 ppm
12:58 pm -
35 ppm
2:20 pm
15 ppm
12:59 pm ¦
- 20 ppm
2:25 PM
0 ppm
1:00 pm •
- 15 PPM
B-17
-------
GRir
LANDMARKS: 26 ft from #5
AO FT FROM #2
24 FT FROM //4
23 FT FROM SMALL AERATOR
30 FT FROM LARGE AERATOR
START 7:30 AM
9:10 AM - 0 PPM (#4 OPENED)
9:14 am - 5 ppm
9:15 am - 60 ppm
9:16 am - 85 ppm
9:17 am - 80 ppm
9:20 am - 40 ppm
9:25 am - 15 ppm
9:30 am - 0 ppm
12:35 pm - 0 ppm
12:37 pm - 0 ppm (#4 & #5 opened)
12:40 pm - 20 ppm
12:41, pm - 30 ppm
12:44 pm - 30 ppm
12:45 pm - 20 ppm
12:50 pm - 10 ppm
1:00 pm - 0 ppm
3:30 pm - 0 ppm
B-18
-------
GRID 8
LANDMARKS: 10 ft from #4
10 FT FROM #5
6 FT FROM 8M AERATION CABINET
START: 7:00 am
7:00
am ¦
- 0
PPM ~
9:00
AM ¦
- 0
PPM
9:40
AM -
• 155
PPM
1st PEAK - #4 OPENED
9:42
AM -
• 250
PPM
2nd PEAK - #5 OPENED
9:45
AM -
90
PPM
~
9:50
AM -
25
PPM
9 PLASTIC 1000 ML GRADUATES
10:00
AM" *
- 20
PPM
PLACED ON TOP OF AERATOR
10:30
10
DUE TO LACK OF ROOM
AM -
PPM
REMOVED 11:00 AM
11:00
AM -
10
PPM
11:30
AM -
0
PPM
B-19
-------
GRID 8 (cont'd)
11
50
AM -
0
PPM
11
51
AM -
- 75
PPM
11
52
AM "
- 150
PPM
11
53
AM ¦
- 195
PPM
11
55
AM ¦
• 75
PPM
12
00
• 20
PPM
12
05
PM -
7.5
PPM
12
20
PM -
¦ 0
PPM
1st PEAK - 05 OPENED
2nd PEAK - #4 OPENED
Small load containing •
2 TRANSDUCERS AND 2
TUBINGS
2:05
PM -
0
PPM
2:06
PM -
65
PPM
2:10
PM -
10
PPM
2:21
PM -
15
PPM
2:30
PM -
5
PPM
3:00
PM -
0
PPM
#5 OPENED
Several items sorted and
PLACED ON TOP TAKEN TO
LARGE AERATOR
B-20
-------
GRID 0
LANDMARKS: 30 ft from //5
45 FT FROM #2
27 FT FROM SMALL AERATOR
34 FT FROM LARGE AERATOR
28 FT FROM #4
START: 8:00 am
9:50 am ¦
- 0
PPM
(//4 OPENED)
3:49
PM ¦
- 25
PPM
9:54 AM ¦
- 3
PPM
3:50
PM ¦
- 40
PPM
9:55 am ¦
- 30
PPM
3:52
PM -
- 35
PPfl
9:56 am ¦
¦ 40
PPM
3:55
PM -
- 15
PPM
9:57 am -
¦ 42
PPM
4:00
PM ¦
- 0
PPM
9:58 am -
• 33
PPM
4:05
PM ¦
- 0
PPM
10:00 am ¦
- 15
PPM
4:06
PM -
¦ 40
PPM
10:05 am -
• 5
PPM
4:07
PM ¦
- 53
PPM
10:10 am -
• 0
PPM
4:08
PM -
- 30
PPM
2:30 pm -
¦ 0
PPM
(#4 opened)
4:10
PM •
¦ 25
PPM
2:34 pm •
• 5
PPM
4:15
PM ¦
- 15
PPM
2:35 pm ¦
¦ 25
PPM
4:20
PM -
- 5
PPM
2:37 pm -
• 55
PPM
4:25
PM -
¦ 0
PPM
2:39 pm -
- 50
PPM
8:25
PM ¦
¦ 0
PPM
2:40 pm -
¦ 25
PPM
8:30
PM -
¦ 5
PPM
2:45 pm -
- 5
PPM
8:33
PM -
• 20
PPM
2:50 pm -
¦ 0
PPM
8:35
PM -
¦ 20
PPM
3:45 pm -
¦ 0
PPM
(#5 opened)
8:40
PM -
¦ 0
PPM
B-21
-------
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— - A - #5 opened
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B - #4 opened
0 « 29 Ft
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TIME of Dry
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Events:,
; A -!#4 opened
i :D = 11 Ft
¦ 1 I '
< B -!#5 opened
' jD =? 9 Ft ;
C - #5 opened
;D = 9 Ft
t
!
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-------
too
10
Events: •
A -r 14 opened
: D = 24 Ft
B - #4 & 5 opened
, D - 24 Ft & 26 Ft
' T
i
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ti it
TIME OF DRY
ft- OPENEP
; D= HlfT
8- *1 OPENSD
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-------
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events j
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j ' ^
Br #4 JS" oPiauw'P
: d « io ft
^ 5" ppew*&
D -
.C/^_SRM€ .*5 R '
OF DAY
-------
SUMMARY OF AREA SURVEY
GRID
1
2a
2b
3
4
5
6
7
3
9
10
#2nd shift
IMA
1.96
1.47
1.16 3,38*
2.94
0.24
0.43
3.20
2.09
10.04
2.73
0
B-29
-------
APPENDIX C
PRACTICES RELATIVE TO WORKER
EXPOSURE AT SELECTED SITES
C-l
-------
TABLE C-l
PRACTICES RELATIVE TO WORKER EXPOSURE AT
HEALTH CARE FACILITIES
0
1
N>
Sterilization/Fumigation Equipment
Control Measures Implemented
State/
Sice
Equipment
Manufacturer/
Size (ft1}/
Age (years)
Sterllant
Used
Cat Removal
Systea
Total
Number of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETtf
Arizona
Sice A
3M(M200)/
2/10
100Z ETO
Vented to
atmosphere.
10
Workers wear no
protective clothing
Aerator vented to
outside atmosphere
Sterilization
conducted in
Limited access to steriliza-
tion area.
Monitoring has been
done in the past and
3H(400B)/
4/1
1002 ETO
Vented to
atmosphere.
or equipment.
Central Supply
(11,826 ft3).
Utilize 4 aerators.
is being conducted at
present.
Castle 7260/
70/11
I2Z ETO
832 Freon®
Liquid/gas
separator to
atmosphere.
Castle chamber is
unloaded immediately
at end of cycle.
Mechanical area
ventilation with
17.6 air changes
per hour.
Airflow is from
ETO work area
toward non-ETO
vork. area.
Treated materials are trans-
ferred from sterilizer to
aerator in basket or on cart,
treated materials are not
transported by hand.
Have preventative mainte-
nance agreement with 3M for
its chambers; Castle unit
serviced in-house (includes
filter change and gasket
check).
Employees received lectures
and slide program on sterl~
llzatlon process.
Equipment used for
monitoring includes:
Uilks-Miran 1A;
Century Organic Vapor
Analyzer; Gas Tech
Solid State; and JXC
charcoal and gas
chromatograph.
-------
TABT.K C-1 (COeTDDSD)
0
1
Scertliutleft/Taalgteies Equipment
Control Measure* Implemented
State/
Site
EquLpeenc
Manufacturer/
SIM (ft3)/
A|e (years)
Sterilant
Used
Cm Removal
System
Total
lhabet of
Operators*
Potential
Espottirc Situations
Equipment
Betiga
Workplace
D*slgnb
Work
Practices0
Monitoring of
(forkplace for Residual
Levels of ETOc
tkrisooa
Site B
Castle (3045)/
5/5
12X ETO
8it Freon®
Vented to
water drain.
10d
Hot available.
Rone specified.
Sterilisation
conducted In
Central Supply in
general packaging
end processing
area (Central
Supply sewures
44* z 24' x 9.25';
ETO work area,
measures 101 x
9' * 9.25').
Environment Is
controlled
through air con-
ditioning with 1C
air changes per
hour.
Direction of air-
flew Is fros npn-
ETO areas to ETO
work area.
Aerator located -
In separate 7400
ft3 room (sterile
stores).
Access to ETO work area la
limited to ETO sterilization
workers-
Other work practices not
detailed.
Mot available.
-------
TABLE C-l (OOtrrntJED)
State/
Site
Sterilisat
loo/Pualgatloa Equipment
Total
Nober of
Operators*
Potential
Exposure Situations
Control Measures Implemented
Equipment
Manufacturer/
Sire . c
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETCP
Arizona
Sice C
AMSCO/
30/5
12Z ETC
98Z Freoo#
Exhausted to
•ever.
2
Sot available.
Chanber equipped
with door interloc
to prevent opening
of door before com-
pletion of cycle.
3M units equipped
with purge systea
and interlocking
door aecbaalsm*
Sterilization
conducted in
Sterile Proces-
sing and Distri-
bution area (SPD]
(12.977 f«?).
Supplied air
positive with
10.8 air changes
per hour.
Direction of air-
flow Is froa ETO
work area to non-
ET0 work area.
Access to both ST0 work area*
is Halted to ETO sterilisa-
tion workers.
At end of cycle, operator
opera doors and then, after
15 minutes, unloads
sterilizer.
Operators wear gloves when
retrieving treated material
from steriliser.
Operators receive ongoing
training, lectures* slides,
and written exams.
Quarterly inspection of
steriliser performed by
hospital engineering service.
District Engineer
Safety Inspector used
Hllks-Hiran to aonitoT
ETO work area; addi-
tional data were not
reported.
3M <403)/
4/5
10QZ ETO
Tented to out-
side atmosphere
3M (400)/
4/4
100Z ETO
Vented to out-
side ataoBpher«
* (200)/
2/3
100Z ETO
Tented to out-
side atmosphere
2
2
Sterilisation
conducted in
decontamination
•tea (11.112 ft?).
Supplied air
negative with
2 air changes
per hour.
Direction of air-
flow Is froa ETO
work area to noa-
ETO work area.
3M(200)/
2/3
100% ETO
Tented to oat-
aide atmosphere.
-------
table c-i (cmrrmuu»
0
1
Ln
State/
Sice
Sterilization/Fumigation Equlpaeat
Total
Ruaber of
Operator**
Control Measures lepleaented
Monitoring of
Workplace for Residual
Levels of ETOc
Equipment
Manufacturer/
Site (ft3)/
Age (year*)
Sterilant
Used
Gas KcMval
syit«
Potential
Exposore Situations
Equipment
Design
Workplace
Design^
Work
Practiced
Arinoa
Sice D
3M (200)/
2/1
100Z ETO
Vented to
sewer.
1
Mot available.
Hot available.
Sterilisation con
ducted in respi-
ratory therapy
area <6* x 12* *
8').
Mechanical area
ventilation.
Access to both ETO sterilisa-
tion areas Is limited to ETO
sterilisation workers.
Sign is posted next to steri-
liser indicating that after
door is opened operator Bust
wait 5 minutes before remov-
ing basket.
New employees receive com-
plete orientation on ETO
procedures.
Hospital maintains preven-
tive maintenance agreements
with sterilizer Skanufacturers
for inspection and service.
State Compensation of
Arizona conducted
monitoring In 1978
and 1979 using Wilks-
Miran; no problems
reported.
Another hospital con-
ducted monitoring at
this hospital in 1979
using Uilks-Miran;
found TWA levels to b«
below 50 ppm.
Hospital purchased its
own Wilks-Miran In
1960; teats have not
been suuie as of August
1980.
3M (400)/
4/5
1001 ETO
Vented to
ataotpbext.
4
Treated materials
carried in basket by
operator to aeration
chamber located in a
room 12* amy fro*
ETO work area.
Mot available.
Sterilisation con-
ducted In Supply
Processing and
Distribution (SPD)-
(36' x 36* * 8*).
Mechanical area
ventilation with
10 air exchanges
f>er hour (267
cfaM
Positive airflow
Ln BT0 work area
from non-ETO work
urea.
Castle (4060V
60/6
I2t ETO
&8Z FreocP
Vented to
atmosphere.
-------
TABLE C-l (COrraUVD)
State/
Sice
Sterilltatloa/TiHlgetloa Equipment
Total
Hmber of
Operators*
Potential
Exposure Situations
Control Measures Inpleaented
Monitoring of
Workplace for Residual
Levels of ETtf
Equipment
Manufacturer/
Slse (ft*)/
Age (years)
Sterilant
Osed
Cai Kawval
Systea
Equip* eat
Design
Workplace
Design
Work
Practices
California
Site A
AMSCO/
30/5
12Z STO
S8X Preon®
Tented to out-
side atmosphere-
u-u*
Hot available.
Multiple post-
vaeuuas.
Sterilisation
conducted in
Sach sterilizer is opened for
15 nioutes before retrieval
of sterilized aaterials.
Sloves are vorn by workers
vhen material transferred
to aerators (2) or open shelf
unit (1) for aeration.
3pen shelf aeration is con-
ducted at least 20 ft. froa
any working areas and has no
eaployee traffic.
List of hazards associated
with ETO are posted near
chaabers.
Workers receive initial and
continuous in service
training*
Preventative Maintenance
contract for cbaabers with
aanufacturers.
Access to sterilization area
is United to (but not parti-
tioned froa) sterilization
technicians.
Hone
3M(202)/
4/3
100Z ETO
Vested to out-
side ataosphere-
One post-vacuun.
Ihit has inter-
lock door and air
purge.
(18* x 14%* x
14V) with 20 air
changes per hour
-------
table c-i (corrnejED)
0
1
Sterilization/Fumigation Eqnlftat
Control Measures Iflewented
State/
Site
EqtilfMBt
KamlacCvrct/
Sit. (ft3)/
A(e (years)
Sterilant
Used
Gas rw—b1
System
Total
Suaber of
Operators*
Potestlal
Exposure Situations
Equipment
Besign
Workplace
Dcslgn>>
Work
Praet ices^
Monitoring of
Workplace for Residual
Levels of ETO*"
CdlforaU
Site B
W(40M)/
*/
-------
US££ C-l
-------
TABLE C~1 (CneiHDKD)
0
1
\D
Sterilisation/Fumigation Equipment
Total
ftabcr of
Operators*
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOC
State/
Site
Equipment
Manufacturer/
Sice /
Age (ye»r«)
Sterllant
Used
Cm tceoval
System
Equipment
Design
Workplace
Designb
Work
PractlcesC
Colorado
3M (400)/
4/3
10QZ ETO
Continuous
purge via pipe
to outside
atmosphere.
10
Hot available.
3H sterilizers
have Interlock* to
prevent opening of
door prior to
cycle completion-
In 3M <400*1 unit,
tlw cycle can be
aborted. In which
cue the gas is
purged before door
can be opened. If
gu is not purged,
only service nan
can unlock unit.
Utilise 3 aerators;
2 vent to room
atmosphere, 1
vents to outside
atmosphere.
All sterilizers
and aerators
located in Cen-
tral Supply
(35' x 30* x 8').
Mechanical area
ventilation with
8 to 10 air
ehanges per hour.
Access to ETO work area Is
Halted to ETO sterilization
workers.
At completion of cycle, door
is unlocked and opened ap-
proximately 2 Inches for 15
minutes. Then door Is opene<
completely for another 15
minutes before contents are
removed.
Workers wear rubber gloves.
Move sterU I red materials
directly Into aerators.
Workers receive initial
orientation and proficiency
easting for sterilisation
operation, as well as a
refresher course every 6
months.
Quarterly Inspection and
maintenance by manufacturers
with additional calls as
deemed necessary at other
times.
Additional supervisor hired
to monitor all aspects of
sterilization, aeration, and
storage of sterile supplies.
None
3H (4008)/
4/1
Castle (3045)/
9/2
100X ETO
12X ETO
88Z rr*cx^
-------
TABLE C-l (CONTIHUKD)
0
1
I—1
o
Sterilisation/Fumigation Sqalpatnt
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Gas Kenoval
System
Total
Nuaber of
Operators'*
Potential
Exposure Situations
Equipmtnt
Design
Workplace
Design
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ET0C
Connecticut
Site K
AKSCO (Medal-
lion M65G)/
5.5/9
122 ETO
881 Freoo®
Vented to out-
side atmosphere
ud
Access to ETO work
area is not limited
to sterilisation
workers.
Aerator vented to
outside a&osphse.
Sterilisation
conducted in
Central Supply
<30' * 3V * 9').
Mechanical area
ventilation and
window aeration
with 5 to 10 air
changes per hour.
Direction of air-
flow is to non—
ETO work area
from ETO work
area.
Chamber door 1b opened at enc
of cycle and left open for IS
minutes before unloading*
Operators wear gloves when
transferring treated material
to aerator.
Employees receive sterilizer
training when first intro-
duced to sterilization
operations.
Sterilizer serviced quarterly
by AMSCO.
In-house analysis con-
ducted of air samples
taken before and aftex
completion of steri-
lizing cycle; hospital
reports that samples
were within "normal"
limits.
-------
TABLE C-l (CtVTLHUSD)
Stcrillucloo/Fia^ttlot Equipment
Control Measures Implemented
State/
Site
IqalfMat
Metufsctarer/
Sice (ft3)/
A|< (years)
Sterllsnt
Seed
Gas Keaoval
Syita
Total
Vuaber of
Operators'
Potential
Exposure Situations
Equlpaent
design
Workplace
Design^
Work
Practices0
Monitoring of
Wotkplaee for Residual
Levels of ET0C
CeaMetiait
Site «
M (400)/
4/4
10QZ ETO
Coatlnooos purge
to outside
KtBoephare.
u4
Hot available.
3M sterilizers
equipped with
Interlocks to pre-
vent door froa
openiag while
cycle Is operating
Two aerators
vented to outside
atmosphere.
Sterilisation
conducted in Cen-
tral Supply (com-
bination of work
room and sterili-
sation room).
Sterilisers and
aerators are
located In wall
between sterl—
User rooai (26* z
6'7" s 10') sod
work rooa (50* *
17* x 10*).
Sterilizer rooa
is mechanically
vented to outside
atmosphere vith
12 air changes
per hour.
Direction of air-
flow Is from noo-
KTO area (work
rooa) towards ETC
work area (steri-
lizer rooa)
to outside
staoephere.
Access to ETO work area
limited to employees la
general work areas; however,
no one Is allowed in steri-
liser rooa during steriliza-
tion. operations •
At end of 3M units* cycle,
door is opened and operator
waits 10 minutes before re-
moving treated materials. At
end of AMSOO unit's cycle*
door is opened end room is
evacuated for 10 ainutes
before reaoving treated
materials.
Operators wear cotton gloves
when mlftMIng ch—tier.
Each worker receives 12 hours
per year of ETO training,
Including ETO seminars, tapes,
slides, video cassettes,
movies, and lectures.
Preventive maintenance per-
formed on chambers every 6
months. Maintenance Includes
replacement of gasket, spray
nozzle* filter, and other
Mill 1 parts susceptible to
wear. Timing and sequence of
operation are checked out, ai
is steriliser, for broken me-
chanical parts.
AETHA Insurance Co.
has analyzed air
around sterilizer and
has not detected any
concentrations of ETO;
additional data was
not reported.
* (400)/
4/1
100E no
Continuous purge
to outside
ifwtphert'
AMSCO/
1.63/14
12Z ETO
wx ma<&
lerhsnlol
purge to eterl-
Lisatloo rooa.
-------
TJlBLE C-l (COHTSDra)
0
1
I-1
StcrillsatloQ/Puaigatioa Bqulpeeot
Control Measures Implemented
State/
Site
Equlfawt
Manufacturer/
SUe (ft5)/
Age (years}
Sterilant
Used
6m ImwmI
Syatea
Total
Nuafeer of
Operators*
Potential
Exposure Situation*
Equipment
Design
Uorfcplace
Design*1
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
Delaware
» (400)/
4/6
100X KTO
Vented to out-
aide ataospfcere
4
Hot available.
Aerator vented to
outside atmosphere
Sterilization
conducted in
Central Supply
Service {23* x
18' x 12').
Ventilated fcy air
conditioner with
circular airflow.
Access to ETD work area is
Halted to BTO sterilisation
workers.
At end of cycle, operator
opens door slightly and
leaves area for approximate^
15 minutes •
Treated aaterials are trans-
ferred la aerators in mrtnl
baskets*
Use 3M ETO booklet to train
workers oo sterilisation
procedures•
Hospital has Maintenance con-
tract trlth 3M for inspection
and service of chaaber.
None
-------
TABLE C-l (CUfTiMUKD)
0
1
W
U>
Sterlllsatlon/Fumlgatlon Equipment
Control Measures Iaplem ented
State/
Site
EqalpM&t
Manufacturer/
Sis* (ft3)/
(years)
Sterllant
Used
Gas Bi ti ii ¦!
sy»t-
Total
lfuaber of
Operators*
Potential
Exposure Situations
Equifent
Design
Workplace
Design*
Work
Fract icesc
Monitoring of
Workplace for Residual
Levels of ET0C
Florida
Slt« A
AMSCO (S&-68K2))
30/3
12Z ETO
88Z Freoe®
Vented to out-
side atwMphere
3
ETO chaabers not
regularly Inspected.
Chssber has safetj
lock, which is
engaged by chambei
pressure.
AKSCO
-------
TABLE C-l (COenHOED)
0
1
t-1
-p-
Sterilisation/Fumigation BqulfMDt
Control Measures Implemented
State/
Site
Sqalput
Manufacturer/
Site (ft3>/
Age (years)
Sterilant
Used
Gas Removal
Sys t«
Total
lfaaber of
Operator**
Potential
Bxpotore Situation*
Equipment
Design
Workplace
Design13
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ET0c
Florida
Site B
AKSCO QC5G)/
5/7
12Z KTO
88% Freo^
Condenser watei
to floor drain*
5
Hot available •
Aerator vented to
roof exhaust fan.
Sterilisation
conducted in
Central Supply
(19*6" x 20*4" x
8').
Mechanical area
ventilation with
air movement of
1100 cf>t
(supplied) and
1000 cf«f
(exhausted).
Direction of air-
flow is to ETO
work area froa
non-ETO areas.
Additional ex-
haust fan near
floor drain (290
cfn 6"); rfovea
escaping vapor
from condenser
water drain.
Access to ET0 sterilization
area United to ET0 sterili-
sation workers.
At end of cycle, chaaber door
Is opened approximately 6
Inches for IS minutes before
removal of cart.
Operator wears gloves when
pulling treated materials
from sterilizer and placing
the* cm rack to aerate for
2 hours.
Bee workers given procedure
book end instruction by
senior employee.
A quarterly Maintenance
schedule Is maintained for
electrical motor and pump,
recorder door, and manual
test.
Air samples at hospi-
tal monitored by
Boebrlnger Labora-
tories , Inc. Hospital
reports that results
were positive; no
additional data were
reported.
-------
tawk c-i (ccansnsi)
0
1
(-*
U1
Sterillxatloa/Fialgatlon Equipment
Control Measures Iapleaented
State/
Sice
Equipment
Manufacturer/
SUe (ft3)/
Ag« (years)
Sterllant
Used
Gas tiifiinl
Sjratas
Total
Riaber of
Operators8
Potential
Exposure Situations
Equipment
Besign
Workplace
D««l*nb
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOC
Georgia
Site k
AMSCO
(Cryothexa)/
3/9
12X BIO
881 Freoo®
Vented to rooa
located between
gas and iteaa
sterilizer.
16fl
Access to ETO work
area la not
restricted.
Hot available.
Sterilisation
conducted In
Central Service
(25' x 15* * 8f).
Passive area
ventilation with
direction of air-
flow froa ETO
work area to non-
ETO work area.
Safety precautions are
postfed and enforced.
None
-------
TABLE C-t (OWTIHDXS)
o
t-1
ON
State/
Site
Sterilization/Fumigation Equipment
Potential
Exposure, Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Level! of ETOF
Equipment
Manufacturer/
Size Cft3)/
Age (years)
Starilent
Used
Cm Rcaoval
System
Total
Number of
Operators*
Equipment
design
Workplace
Dulgnb
Work
Practices0
Georgia
Site B
AKSCO
(Cryotherm) /
9/4
121 ETO
882 FreodS
Vented to out-
side atmosphere.
is"
Sot available*
Aerator vented to
outside atmosphere*
Sterilization
conducted in
Central Supply
(51* * 14* * 9').
ETO sterilisa-
tion conducted
In sane room as
steas sterilisa-
tion; ETO chaabef
located at one
end of room, amg
fro* other work •
areas.
Mrrhsnlrnl area
ventilation with
10 air changes
per boar.
Airflow is from
ETO work area
to outside
atmosphere.
Limited access to Central
Supply area*
At end of sterilization cycle,
chamber door is opened at
least 6 inches, and employee
moves froa ETO work area for
at least 15 minutes.
Sterilized materials are
placed in Castle aerator,
which is next to ETO steri-
liser. Employees wear dis-
posable gloves when handling
these items*
Workers are trained on ETO
procedures vith written in-
structions and testing.
These instructions are re-
viewed and/or updated at
least annually*
Preventative aalntenance con-
tract with asnufacturer for
Inspection and service every
other month.
Private company moni-
tored workplace to
determine if employees
might be exposed to
excessive concentra-
tions of ETO. Using
a Draeger multi-gas
detector, the company
found levels of zero
ppa at chamber door
during changing of
sterilizer; at drain;
chamber door with door
open after cycle; and
at aeration door after
12 hour aeration
cycle. Levels of 35
ppm were detected
within chaaber after
sterilization cycle.
-------
TABLE C-L (CONTINUED)
n
I
Sterillutloa/ToiiiiatiM Equipment
Control Measures Implemented
State/
site
Equipment
Manufacturer/
Siu (£tJ)/
Age (year*)
Sterllant
Used
Cm Kaaoval
System
Total
Bomber of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Deslgnb
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETOC
Illinois
Site A
AHSCO/
6/10
121 ETO
68Z Freoo®
Vented to sewer
and to outside
atmosphere.
6
Sot available.
At end of cycle,
there are two
filtered air
purges. Steri-
liser equipped
with safety lock
door •
Sterilisation
cooducted in
Central Service
(4V s 22* x
10*).
Negative pressure
room at rear of
all sterilisers
sad aerstors,
with large 21
Inches extractor
fas continuously
in operation.
Positive pres-
sure ventilation
in dean area
(front of steri-
lisers end
aerators) with
7-10 air changes
per hour.
Direction of air-
flow is towards
ETO work area
frost non-870
work area.
Access to sterilisation work
area limited to authorised
Central Service personnel.
At end of sterilisation cycle,
chnber door is opened 6
inches and the i*edLate area
is cleared for at least 15
Minutes; operator lets col-
leagues know of door being
opened.
Operators wear heavy cloth
gloves when transferring
sterilised materials to
aerator treated items are
subjected to 8 changes of air
per alnute for a ninfsins of
16 hours for a 3 hour isola-
tion load end for a minima
of 12 hours for a normal 2-
hour sterilization load.
New technicians receive
thorough orientation/training
and are subject to close
supervision by Senior Techni-
cian and Department Super-
visor at all tines. Every 3
months a Department Inservice
Education Revision is done
with all technicians.
Hospital has quarterly FMA
contract with AMSCO.
Supervisor of Central Service
keeps close supervision of
technicians to check for poor
work habits and "complacency.1
In the past two years.
Central Service has
had two complete moni-
toring surveys done
for residual ETO con-
centrations: one done
by Central Supply and
the other done by Risk*
Management Insurance
Company (Liberty
Mutual).
Gas chromatography vas
used for both monitor-
ings. Ho specific
problem were iden-
tified and all levels
were considered safe
for TWA concentrations.
Supervisor also uses
Leak TEC Tracer unit
to test for 'silent'
leaks at all pipe fit-
ting unions each
Friday. This action
is documented in
Preventive Maintenance
record kept in
Department-
-------
TABLE C-l (COHTDTOED)
0
1
M
00
Scats/
Sice
Sterlilsati
on/Fumigation
Equipment
Total
Humbec of
Operators*
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Level* of ETO*1
Equipment
Manufacturer/
Slse Ctc3)/
Age (years)
Sterilant
Used
Gas fttwnl
System
Equipment
Design
Workplace
Deslgnb
Work
Practices0
Illinois
Site B
AMSCO
(Cryo therm) /
30/9
12Z ETO
68Z ?reon®
Vented to out-
side atmoshere.
1
Hot available.
Steriliser equip-
ped with pulsing
vacuum-
Aerator vented
to outside
atmosphere.
Sterilisation
conducted in
Central Supply
(630 sq. ft.).
Sterilization
area is not in a
separate room
but is separated
from other work
areas*
Exhaust fans in
windows at rear
of sterilizer
and fans in front
of steriliser.
Direction of
airflow is toward
ETO work area
from noa-ETO
work area.
Access to ETO work area
limited to sterilisation
workers.
At end of sterilization cycle,
chamber door is cracked, left
open for 15 minutes before
the treated material is trans-
ferred to aerator.
Workers follow AKA ETO use
guidelines, view AMSCO slide
presentation on ETO sterili-
sation, are given articles to
read on ETO.
Hospital has PMA Agreement
with AMSCO for quarterly ser-
vice and Inspection.
Exhaust fans are turned on
when ETO sterilisation cycle
begins and remains on until
end of aeration cycle.
Although hospital doet
not conduct monitoring
at present, Biomedical
Engineering Department
is acquiring a gas
analyser to check and
monitor levels of ETO
on a frequent basis*
-------
table c-i (comuBD)
State/
Sice
Sterillsatlon/FtMlgation Equipment
EqnlpMBt
Manufacturer/
Sise (ft3)/
Age (years)
Sterilent
Used
Gu l«o«al
System
Total
Rwfcer of
Operators*
Potential
Exposure Sltuatloi
Control Messures Implemented
Equipment
Design
Workplace
Design**
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
Illinois
Site C
0
1
AMSCO
{Cryother
20/5.5
i)/
12Z BIO
88X Freoo®
(Dcoo-12)
Vented through
filter to ven-
tilation systes
Hoc available.
Interlock on cham-
ber door to pre-
vent opening of
door before end of
cycle.
Prior to opening
of chasber door,
the steriliser
performs e 10-
mlnute purge cycli
to expel residual
ETO gas.
Hospital Is con-
sidering Instal-
lation of hood
above gas steri-
lizer connected
to ventilating
system that would
draw any addi-
tional vapors up
and out of depart-
Best when chasber
door is finally
opened*
Sterilization
conducted in
Central Suoply
(24' * 36' x 9«).
Hwrhsnlrsl ares
ventilation with
10-J5 sir
changes per day
Direction of air
flow is to ETO
areas from non-
R0 work areas.
An sir return
vent 1s located
above tbe aera-
tor «xhaust (all
of which Is In
an area enclosed
by brick walls).
Access to ETO work srea
Halted to ETO sterilization
workers-
At end of sterilization cycle,
chamber door Is opened 1-2
Inches snd attending techni-
cian leaves steriliser sres
for 30 minutes before re-
trieval of treated items.
Technicians wear only stan-
dard scrub gear when operat-
ing chsaber.
Technicians are instructed by
department coordinator during
job orientation on proper
procedure for working with
gas sterilization.
All Central Supply equipment
is on regular preventative
maintenance schedule main-
tained by hospital engi-
neering and Maintenance
department-
American Hospital
Supply Company tested
with hand-Controlled
gas chromatograph on
hospital's sterilizer
and reported not find-
ing any leaks*
-------
TABU C-l (CONTINUED)
CI
I
N>
O
Sterilization/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterllant
Used
Gas Rceovtl
Syatcs
Total
Number of
Operators3
Potential
Exposure Situations
EqulpiMnt
Design
Workplace
Design ^
Work
Prsctlcesc
Monitoring of
Workplace for Residual
Levels of ET0C
Illinois
Site D
AMSCO
(M6S6 PD) I
30/3
12X ETO
S8Z Freon®
fept$d through
celling into
duct work.
25d
Not available.
Aerator vented
to duct work
through pipe in
ceiling.
Sterilization
conducted iik
Central Supply
(52' x 24» x 8')
ETO work area
(separate too*)
is 2 ft. loag x
21 ft. vide.
Mechanical area
ventilation trith
26 air changes
per hour.
Direction of air-
flow is away fiea
£T0 work are*-
Access to ETO work area is
limited to sterilisation
workers*
At end of cycle, the operator
opens cfcaaber door, then
leaves area for « short
period.
Operator occasionally wears
gloves.
Hew operators receive on the
job training in steriliza-
tion techniques; periodic
in-service review for all
ea^loyees.
Maintenance conducted pri-
marily in-house. Maintenance
¦an is taking an AMSCO main-
tenance training course.
Use 60 Inch aerator that
accepts steriliser cart;
therefore, treated materials
do not have to be handled by
operator.
At one time, Wilks-
Miran 103 Ambient Air
Analyzer was used to
monitor ETO work area.
Hospital reports that
do problems were de-
tected; additional
data not available*
-------
TABLE C-l (COmiDBD)
n
ro
Scerlliiatlon/FuBlgation Equlpeent
Control Measures Inple
seated
State/
Site
Equipment
Manufacturer/
Sis* (ft3)/
Age (years)
Sterilant
Used
Gas lewral
SystM
Total
Rubber of
Operators*
Potential
Exposure Situations
Equlfstut
Design
Workplace
Design*3
Work
Practleesc
Monitoring of
Workplace for Residual
Levels of ET0c
Illinois
Site E
Castle (3045)/
8/2
12Z ETO
SSZ Freoo®
Vented to atmo-
sphere above
steriliser and
purges through
drainage
•7"tea.
Access to steriliza-
tion area Is United
to 1 to 2 eaq»loyees,
but 9 other employees
work In general area.
Utilise Castle
Model 4041 aerator
and two sections
of open shelves
for aeration.
Sterilisation
conducted in an
Isolated area
within Central
Service.
ETO work area
sassures
20* x 24* and
Central Service
¦ensures
44' x 56(.
fcechaalcal area
ventilation with
15 air changes
per hour.
Direction of air-
flow is towards
ETO steriliser
froa ETO work
area.
Hot available.
Not available.
-------
table c-i
Power door
Interlock-
Aerator vented to
outside ataosohere-
Sastle steriliser-
Sterilization
conducted in
Central Supply
(M)' * 40*); ven-
tilation is pas-
sive with 6 air
changes in rooa
per hour;
direction of alr-
flov Is to ETO
work area.
At end of cycle, operator
opens chaaber door and
leaves work area for IS
minutes.
Sterilised materials are
transported froa sterilizer
to aerator in wire baskets -
Operators receive inservi.ce
education on ETO sterlllza-
frotn department management.
Monitor workplace on c
weekly basis using
Hational Draeger-
Vacuun Tube Collectiot
and Surgical-Analog
Electrical Metering
Device. No problea
areas noted*
AMSO0/
9/2
12? ETO
881 Freoc/®
Tented to out-
ilde atmosphere.
1
Not available.
kover door
Interlock.
terator vented to
outside ataosphere.
AMSCO sterilizer:
Sterilization
conducted in aat-
julatory surgery;
(20* x 30*); ven-
tilation la pas-
sive with 12 air
in rooa
per hour;
direction of air-
flOT Is to ETO
work area fraa
ooo-ETO work
area; access to
this area llalted
to sterilization
workers*
Hospital Engineering Depart-
aent inspects and services
equlpaent dally.
-------
TABLE C—1 (CGKTUHJED)
0
1
ro
u>
Sterillsatlon/Piaaigatioa Eqaipaent
Control Measures lapleaented
State/
Site
Equipment
Manufacturer/
Sice (ft3)/
Age (years)
Sterilant
Used
Gas Reaoval
Syatea
Total
Nuaber of
Operators8
Potential
Exposure Situations
Equipment
design
Workplace
Design1*
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ET0C
lanw
Site B
3M (400)/
4/>l
100Z BTO
Vented to out-
side ataospfaecc;
I
Not available*
Aerator vented to
utility rooa,
which is vented
to outside of
building via ex-
haust fans.
Sterilization con-
tacted in Pro-
cessing Rooa of
Central Supply
(10* x 3S' x 8*).
4echanical ares
ventilation.
Bate of air aove-
eent is: 900
cfwfi (return air
vents over front
af steriliser)
and 400 cfnf
(exhaust in ae-
cbanirsl areator).
At one tine, both
sterilizer and
aerator were used
and vented into
the sane rooa
irlth the operator
the mechanical
area has since
been partitioned
off.
At end of sterilisation
cycle, chamber door Is opened
about 6 inches and the area
Is vacated for 15 ainutes.
Workers wear gloves vhen re-
aoving basket (containing
sterilised Materials) fro*
steriliser and placing in
aerator.
Operators receive written
policy and procedures on
ET0 usage and ln-depth
training on the job*
Routine visual Inspection of
chaaber conducted, including
leakage checks and internal
cleaning.
None
-------
TABLE C-l (COHT1HOED)
o
(
ro
Sterilisation/Fumigation Equipment
Control Measures Implemented
State/
Site
Equlpmit
Manufacturer/
SUe (ft3)/
Age (years)
Sterilant
Used
Gas Reaoval
System
Total
Muaber of
Operators
Potential
Exposure Situations
Equipaent
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Louisiana
AMSCO (M6SG)
8/5
121 ETO
881 Freoo®
Exhausted to
sewer.
5-6
Mot available.
Two post-vacuums.
Door lock actuates
under pressure.
Three aerators
used; vented to
atmosphere.
Steriliser and
aerators located
in Central Ser-
vice area (1447
sq. ft.).
Mechanical area
ventilation in
work urea with
10 air changes
per hour.
Airflow is from
non-ETO areas to
ETO work area.
Access to ETO work area
limited to ETO operators-
Operators follow AMSCO guide-
lines for use of ETO steri-
lizers and aerators. These
guidelines, as well as ASHCSP
guidelines* are posted on
vail next to steriliser door.
Materials are sterilised on
a loading car. Loading car
is pulled to aerator and
pushed inside.
Workers wear cotton gloves
when retrying biological
indicator from test pack •
Worker training includes:
ongoing program taught by
director of central service
and films on ETO (purchased
from AMSCO and Castle).
Monthly prograa of equipaent
inspection and maintenance.
Had outside source
aonitor process one
time. Found high
levels of ETO when
steriliser first
opened, but levels
down to less than 10
ppa within 7 minutes*
-------
"CABLE C-I (COWTIMIBD)
State/
Site
Sterilization/Fumigation Equipment
Equipwat
Ntoafictatcr/
SllC (ft3>/
Arc (years)
Sterilant
Used
Gu kcaoval
System
Total
Nuabcr of
Operator**
Potential
Exposure Situations
Control Measures Implemented
Equipment
Design
Workplace
De«ignb
Work
Practices6
Monitoring of
Workplace for Residual
Levels of ETO^
Maryland
Site A
3M (400)/
4/6
Vested to out-
side atmosphere
0
1
to
Ut
AMSCO
(Coafclnatlon
Gas/Steam)/
30/2
12Z ETO
B8X Freon®
Exhausted to
ir
Processing staff
worts in area adjoin-
ing ETO work area.
Chamber equipped
with interlocks
to prevent opening
of door until coi
pletion of cycle
Multiple poet-
Cbaaber equipped
with automatic
door.
Sterilisation
conducted in
Supply, Process-
ing, and Distri-
bution (SPD)
(14,080 ft').
Mechanical area
tilation with
11 air changes
per hour.
Aerator vested to
outside atmosphere.
Access to ETO work area
limited to Processing staff.
At end of cycle, both chamber
doors are opened 6 Inches
for IS minutes (AMSCO door
automatically controlled to
open 6 Inches);
no personnel allowed near
sterilizer door when first
Direction of air-
flow is from ETO
work area to oon-
ETO work area.
Following me-
chanical aeration
Material is
placed on desig-
nated shelves.
Operators wear cotton gloves
when removing cart from
sterilizer and placing it in
aerator.
Hew employees Instructed in
procedures for packaging and
operating sterilizers by
Lead Technician; employees
take return demonstrations
until employee is knowledge-
able of eoaplete procedure;
In-service classes are
scheduled during year by
supervisor. Classes may be
taught by representatives of
and 3K Company.
Maintenance personnel as-
signed dally to sterilizer
area. Complete preventive
maintenance program for each
piece of AHSG0 equipment by
hospital Maintenance Depart-
ment personnel. Maintenance
check list is signed by
supervisor. Hospital has
maintenance contract with
3H Company for quarterly
inspection and maintenance.
Draeger Multi-Gas De-
tector supplied by
the United States
Fidelity and Guaranty
Insurance Company was
used in February 198Cfc
Levels of 25 ppa were
detected.
-------
TABUS Cr-l (CORtMOED)
State/
Site
Sterilization/Fualgation Kqulpaent
EqalpMnt
Manufacturer/
Size (ft3)/
Age (years)
Sterllant
0»ad
6M Re®
Syita
Total
Number of
Operator* a
Potential
Exposure Situation*
Control Measures laple&ented
Equipment
Design
Workplace
De»lgr£
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
n
i
ro
o>
Maryland
Site B
AMSCO
(Cryothera) /
15/S
122 ETO
881 Freoi<8
Exhausted to
drain.
Entire opera- Access to both steri-
tlng rooai
staff.d
AMSCO
(Cryother*)/
24/5
122 ETO _
882 Freoo®
Local exhaust
for drain and
for door.
3M (202)/
2/not available
Copper vent to
roof.
lization areas is not
restricted.
Mot available.
Sterilization
conducted in
operating room
(15* x 20' x 9')
Mechanical area
ventilation with
20 air changes
per hour.
Direction of air-
flow Is fro* noi»-
ETO work area to
ETO work area.
Two 3M aerators
vented to rooa
ataoephere.
One AMSCO aerator
vented to general
exhaust (hospital*
air handling sys-
tea does not re-
circulate air).
Sterilizacioo
conducted in
sterile process-
ing area; general
work area aeasire
82' x 60' x 10*;
ETO work area
Measures 26* x
20' x 10*.
Mechanical area
ventilation with
20 air changes
per hour.
Direction of air-
flow is from non-
ET0 area to ETO
work area.
At end of cycle, door is
opened approximately 6 Inches
and all operators leave area,
Treated materials are placed
in basket or carriage and
are lifted or pulled to ap-
propriate aerator. Operators
wear gloves during this
process.
ETO sterilisation procedures
reviewed annually.
Hospital has bimonthly in-
spection of AMSCO equipment
and quarterly inspection of
3M equipment by aaxwfacturers
United States Fidelity
and Guaranty Coopany
monitored for levels
of ETO. Levels of
500 ppn after 8 ain-
utes were detected at
open door of 3M unit.
Other levels detected
range froa 0 to 90
ppa. 90 ppm detected
ia 9 nlnutes approxi-
mately 3 inches above
the floor drain during
air cycle of AMSCO
unit. 50 ppn were de-
tected in 9 minutes
after opening AMSCO
chamber.
Draeger pump with ETO
Detector Tubas (30
puap strokes pet each
test) was used In
monitoring.
in response to high
levels of ETO, hospi-
tal uses 3M unit only
when "cold" cycle
needed; evacuates en-
tire sterilization
area at end of cycle,
rather than waiting
only 15 ainutes; and
installed local ex-
haust at drain and at
chaaber door of AMSCO
unit.
-------
I4BLZ C-l (COetDDBD)
0
1
N>
•^J
SterillutiWFoil|«tiaD Bqalpaait
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Sice c
Maryland
Site C
XI
*/5
LOOZ BIO
Tented to out-
side ediaust
system through
copper tubing-
Rot available*
Mot available.
Hot available.
Sterilisation
conducted in
Central Supply.
Access to ETG sterilisation
area limited to ETO steri-
lisation workers.
Operators follow ASBCSP
guidelines for opening cham-
ber door at end of sterili-
sation cycle (15 minutes
aeration with door open 6
inches).
Employees wear cloth gloves
while transferring treated
materials in vire baskets to
aerator.
In-service training program
on ETO procedures held by
director of Central Supply;
manufacturer representative
holds program every quarter.
Hospital conducts preventive
maintenance oo equipment
every quarter.
Hone
¦an
4/3
1001 no
Vented to out-
side exhaust
tystee through
copper tubing*
Three aerators
vented to outside
atmosphere-
Standard air con-
ditioning for
ventilation with
1-3 air changes
per hour.
-------
TABLE 0-1 (CONTINUED)
0
1
to
00
State/
Site
SterilicatieQ/Puaigation Equipment
Potential
Exposure Situations
Control Measures lapleaented
Equip—at
Manufacturer/
Sice (ft3)/
Age (years)
Sterilant
Used
Gas ReMOval
Systea
Total
Nuaber of
Operators8
Equipment
design
Workplace
Design^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ET0c
Maryland
Site D
AMSCO/
4/12
12Z ETO
881 Freon®
Rented to sewer
drain.
8
Aerator vented to
rooa.
Multiple post-
vacuum.
Sterilization con-
ducted in Central
Service.
fechanical area
rentilat-ioa, with
ion-recirculating
iir (10-12 air
changes per hour.]
Jirectioo of air
flow is froe ETO
irea to non-ETO
irea.
Access to both sterilisation
areas liniced to sterilisa-
tion workers.
At end of cycle, door is
cracked open and left in that
position for at least 10 Min-
utes before chasber is
unloaded.
Sterilizer operator wears
cotton gloves when pulling
sterilizer rack froe
sterilizer to aerator.
Rubber gloves worn during
cleaning of chasber, rack and
carriage; complete juapsuit,
shoe covers, gloves, eesk
available and recoaaended for
personnel performing mein-
tenance tasks; a Scott Air-
pact is available for
eaergency situations.
Workers receive Initial orien-
tation*-training which include*
lecture, clinical supervision,
and written testing. Employee
is not allowed to perform ETO
sterilization alone until abl<
to pass written examination
with a ranking of 85 percent
or better and when supervisor
verifies proper performance.
Yearly review of ETO with up-
date and written testing,
which is kept as part of em-
ployee record.
Environmental moni-
toring has been con-
ducted twice.
Measured ETO concen-
tration of 10 ppn at
aerator exhaust.
3M (400)/
4/2
100Z ETO
Seated to out-
side etaoaphere.
1
terator vented to
coo*.
Sterilization con
ducted in Respi-
ratory Therapy.
Mechanical area
tentiliation, wlti
imreclr culating
iir (8-10 air
Pangea per hour).
-------
TABLE C-l (CONTINUED)
o
N>
VO
Scerilluttott/Pwlgatioa Equipment
Control Measures Ia^le»eoted
Facility/
Locat Loo
Equipment
Manufacturer/
Size (ft3)/
Age (year*)
Sterllant
Used
Caa Resoval
Systea
Total
Itiiatif r of
Operator^
Potential
bporarc Situations
Equipment
Stilgn
Workplace
Design ^
(fork
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
Maryland
Site D
(Coofluded)
Manufacturers service cham-
bers under preventive
¦aintenance agreeaent and
In-house aainteoance person-
nel available to sake
iswedlate repairs.
-------
TABLE C-l (COBTMOZD)
0
1
OJ
o
Sterilisation/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Sin Cft3)/
Age (years)
Sterileat
Deed
Gas Removal
System
Total
Number of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ET0c
Maryland
Site B
AKSCO/
4.5/5
12X ETC
88Z Freon®
Dedicated duct-
ing to outside
atmosphere.
22d
Hot available.
Two post-vacuums.
Aerator vented
to outside
atmosphere.
Sterilisation
conducted in
Central Supply
(A3' x 25* x 10*)
Mechanical area
ventilation with
6-8 air changes
per hour.
Direction of air-
flow is toward
Qon-ETO area from
ETO work area.
Access to ETO vork area
limited to Central Supply
workers (pregnant employees
aot allowed aroond ETO steri-
lisation operations).
AHA guidelines for ETO use in
hospitals are posted next to
steriliser and followed by
employee*.
At end of cycle, operator
cracks door open 6 Inches and
leaves ETO work area for 10
minutes before unloading
chamber.
Operators wear vinyl gloves
when transferring treated
materials In wire basket froe
sterilizer to aerator.
Gloves are disposed of after
use.
New employees receive 6-8
weeks orientation program run
by hospital during which pro-
cedures are reviewed on a
step-by-step basis; they also
attend 1 week Educational
Seminar run by AKSCO;
experienced employees receive
periodic refresher course.
Hospital has PMA contract
with AHSCO for monthly In-
spection snd service.
Monitoring conducted
in 1978 by Vital Signs,
Inc. (Columbia. MD.1.
using Multi-Gas In-
frared Spectrophoto-
meter.
Vital Signs detected
the following levels
of ETO at shoulder
level:
loading sterilizer
3 pp»
unloading sterilizer
6 ppm
during vacuum cycle
1-2 ppm
5 minutes after gas
introduced.. .6 ppm
10 Kinutes after gas
Introduced...5 ppm
15 minutes after gas
introduced...5 ppm
25 minutes after gas
introduced...1 ppm.
Vital Signs also
detected at:
above sterilizer door
20 ppm
door seals
6-2 ppm
aerator door lining
19 ppm
ETO tank manifold
0 ppm.
-------
TABLE C-l (CCHtiaUED)
0
1
u>
Ster llisatloo/Ftmlgatloa Bqulyent
Control Measures Implemented
State/
Site
EqutfM&C
Manufacturer/
Sice (ft3)/
Age (years)
Sterllant
Used
Gas Reaoval
Systaa
Total
Rubber of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Designb
Work
Practices'1
Monitoring of
Workplace for Residual
Levels of ET0c
Massachusetts
AMSCO
8/14
12Z ETO
88Z Freon®
Vented to rooa
ataosphere.
6d
Access to Central
Supply sterilisation
area not Halted to
ETO sterilisation,
workers.
Chanber equipped
with continuous
purge systea and
with safety pres-
sure door lock.
Aerator vented to
outside ataosphere
Sterilisation
conducted in
Central Supply.•
Mechanical area
ventilation
with 10 air
changes per hour.
Direction of air-
flow is towards
ETO woTk area
froa non-ETO work
area.
Central Supply Practices:
At end of cycle, operator
opens door* stands back away
froa door, and waits IS min-
utes before
chsaber.
Operetors wesr gloves; opera-
tors receive initial indoc-
trination and subsequent
refresher sessions.
9ospital contracts with AMSCO
for preventive salntenance;
hospital conducts dally clean-
ing and observation of charts,
llals, and gauges.
Massachusetts JUA
Service perforaed
aonltor Ing with gas
chroaatograph and
detected levels of
15.1 ppa In front of
sterilizer after
sterilization cycle
with door opened and
21.6 ppa on cart
traveling to aerator.
* (200)
2/6
100Z no
7ented to out-
Aide ataosphere
12"
Access to Inspiratory
Therapy sterilisation
area not Halted to
ETO sterilisation
workers.
Aerator vented to
rooa ataosphere
(which is drawn
window exhauat
fan to outside
ataosphere).
Sterilization
conducted in
Respiratory Ther-
apy Department.
Sterilisation
rooa also used
for equ Ipaent
asseably and
packaging (12 *
* 11" z 8*).
Ventilation
through window
exhaust fan.
Direction of air-
flow is toward
ETO work area
froa non-ETO work
area.
Respiratory Therapy Practices:
At end of cycle, chaaber door
opened, basket containing
sterilized aaterlals pulled
out partially, and operator
leaves rooa for 10*15 alnntea.
Operators receive Initial in-
doctrination and Individual
refresher sessions If
necessary.
Interior and exterior of
cabinet cleaned weekly;
vacuus punp valves dlsasssa-
bled end cleaned quarterly.
Hone
-------
TABLE C-l (CONTINUED)
Sterillsatloa/FuBlgaeioo Equipment
Control Measures Iapleseated
State/
Site
Equipment
Manufacturer/
Size (ft3)/
Age (years)
Sterilant
Used
Gas Reaoval
Systas
Total
Nuaber of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Pesigab
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOC
Michigan
Site A
Castle (3240)/
30/3
121 ETO
B8Z Preon®
Vested to
sewer.
5
Not available-
Multiple post-
vacuuu.
Chaaber equipped
with interlocks to
prevent opening of
door prior to cor*
pletion of cycle
and with automa-
tic doors.
Separate exhaust
fan, located above
sterilizer, vents
ETO gas co outside
atmosphere.
Aerator vented to
outside ataospbeTe.
Sterlizatlon con-
ducted in Sterile
Processing and
Distribution
(10,753.1 ft3).
Mechanical area
ventilation with
10.2 air changes
per hour.
Direction of sir-
flow Is fro* non-
BTO work srea to
ETO work area.
Access to ETO work area
United to sterilization
workers.
At end of cycle, eaployee
presses open door button and
walks away froa sterilizer;
15 ainutes later, treated
Materials are transferred
froa steriliser to aerator.
Workers sie given written in-
structions and then demon-
stration on how to operate
sterilizer.
Castle inspects and services
steriliser on a quarterly
basis.
None
-------
TABLE C-l (COHTIHUED)
0
1
u
Sterilisation/Fumigation Equipment
Total
Number of
Operator*1
Control Measures laplosented
Monitoring of
Workplace for Residual
Levels of £TOc
State/
Site
Equipment
Manufacturer/
Size (tthf
Age
-------
TABLE C-l (COHTIH0ED)
0
1
u>
4S
Sterilisation/Fumigation Equipment
Control Measure* Implemented
State/
Site
Equipment
Manufacturer/
SUc (ft3)/
Age (years)
Sterllant
Used
Gu Removal
Syst«a
Total
Nuaber of
Operstorsa
Potential
Exposure Situations
Equipment
Design
Workplace
Design?*
Work
Practices'?
Monitoring of
Workplace for Residual
levels of £T0C
Minnesota
Site A
Sybron/Csstle
(3240)/
30/>l
12X ETO
86Z Fr eon®
CMtlDUMtf
purge to sever
2
Hot available-
V
Aerator la vented
to outside
Atmosphere.
Chamber equipped
with Interlock to
prevent opening oi
door prior to com-
pletion of cycle.
Sterilization
conducted in
sterilization
area of Central
processing.
Mechanical area
ventilation
with 6.7 air
changes per hour
Direction of air-
flow is to ETO
work area from
oon-ETO work
area.
Access to ETO work area
Halted to ETO sterilization
workers.
At end of cycle, door Is
opened 6 Inches and left in
that position for 15 minutes
before treated materials are
removed.
Protective gloves are worn.
ETO sterilization procedures
posted. In-service operator
training.
Itens are stored in enclosed
aerator.
tflll begin chamber manufac-
turer 's preventive mslntea-
snce program in October 1980.
Marsh and McLennan
Insurance Company
monitored ETO steri-
lizer with Oraeger in
April 1980. No addi-
tional information
was supplied.
-------
TABLE C-l (COSTISUED)
0
1
u>
tn
Sterlllsation/Ttmlgatioo Equipment
Total
Number of
Operators*
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0c
State/
Site
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Stcrllant
Used
Gas Removal
System
Potential
Exposure Situations
Equipment
Design
Workplace
Design?*
Work
Practicesc
Minnesota
Site B
Castle (combina-
tion gas/steam)/
60/4
12t ETO
&6£ Freoc^
Tented to
floor drain.
3
Hot available.
Three aerators
vented to outside
atmosphere.
Sterilisation con-
tacted in Central
Supply(40* x 30*
X 8*).
Area ventilation
by ceiling dif-
fusers with 6 air
changes per hour.
Direction of air-
flow Is from noo-
BT0 to ETO work
area.
Additional
exhaust, check
v»lW8 installed
at gas manifold.
Access to work area is
limited to ETO sterilisation
workers.
At end of cycle, operator
leaves the door open for 15
alnntes before removal of
treeted materials.
Operator wears gloves to re-
move carts or baskets from
3M sterilizer and to transfer
them to aerator»
The entire cart or basket is
placed directly into aerator,
located below steriliser.
Operators given Initial
orientation and periodic In-
service seminars; follow AHA
guidelines.
Periodic maintenance per-
formed by chamber manufac-
turers; hospital maintenance
department changes filters,
wipe gaskets, and cleans ex-
terior and interior of
chamber.
Insurance Carrier
monitored with Vari-
able Wave Length
Spectrograph; no
problems reported.
3M monitored with
charcoal tubes; no
problems reported.
TWA levels from ^-8
ppm to 50-75 ppm at
peaks were detected.
Castle/
60/4
12Z ETO
88Z Freoo®
Vented to
floor drain.
3M (400)/
5/1
1001 ETO
Surgicot
Vented to
outside atmos-
phere.
-------
TABLE C-l (CONTINUED)
a
i
&
State/
Site
Sterillzatlon/Fiaslgation Equipment
Equipment
Manufacturer/
Siie (ft3)/
Age (years}
Sterilant
Used
Gas Removal
Sy»tea
Total
Number of
Operator!^
Potential
Exposure Situations
Control Measures Implemented
Equipment
Design
Workplace
Design^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
Minnesota
Site C
3M (400)/
4/4
Continuous
purge to out-
side of build-
ing via copper
tubing.
AMSCO/
8.8/6
12Z ETO
881 Frecx£
Drained to
Treated Materials left
near the chamber when
aerators are full.
Aerators are vented
to room atmosphere.
Interlocks are
installed.
Multiple post-
vacuums by AMSCO
chamber.
Sterilization
conducted in.
Central Supply
(15* *"¦ i
x 45*
Access to work area is
Limited to ETO sterilization
workers.
&t the end of cycle, door is
cracked for 15 minutes; door
is laoediately closed after
Mechanical area
ventilation with
6 air changes pei removal of load,
hour.
3M Medical Products
Service Center and EO
Monitoring Services
conducted monitoring
using Wllks-Miran
Model 103 and/or TSI
Model 1650 Air Ve-
locity Meter; found
inadequate air changes
in the area improper
ventilation for the
area.
Materials are placed in aera-
tion cabinets after sterili-
Directlon of air- nation cycle; if aerators are
flow is to ETO full, the materials are left
worker area. near sterilization chamber
until aerator(s) is available, and consulting with
mechanical engineers
New employees receive on-che-
job and In-service training
on ETO when available.
Step-by-step procedures are
provided in CSS Procedure
garter ly PMA contracted
with manufacturer.
Studying alternatives
to propose remodeling
budget for FT 80.
-------
TABLE C-l (CONTTCUED)
0
1
u>
SterLlizatlon/Fuaigation Equipment
Total
Hiaber of
Operators*
Potential
Exposure Situations
Control Measures Inpleaented
Monitoring of
Workplace for Residual
Levels of ETOc
State/
Site
Equipment
Manufacturer/
Site (ft31)/
Ape (years)
SterLlant
Ussd
Gas leaoval
Syitea
Equipaent
Design
Workplace
Des ign'3
Work
Practices0
Minnesota
Site D
3M (202)/
2/3
100Z ETO
Vented to out-
side ataosphere
by vacuus tube.
23
Mot available-
Chaabers equipped
with interlocks
to prevent open-
ing of chaaber
door prior to co»
pletion of cycle.
Sterilisation con-
ducted In Central
Service Area
eve* * y$n x
10*) •
Mechanical area
ventilation with
12 air changes
per hour.
Work area equip-
ped with 17 open
shelf units.
Access to both work areas is
United to ETO sterilisation
workers.
operator waits 5 ainutes be*
ewe en opening of door and re-
trieval of sterilized iteas.
Operator wears rubber gloves
when reaoving treated aate-
rlals and placing then into
aeration basket.
Manufacturer representative
trains saployee regularly; no
ooe operates aschlne before
training.
Bloacdlcal engineer cleans
water Inlet weekly.
Equipaent inspection la
covered by annual aalntenance
contract with the equipaent
aanufacturer.
None
3H (202/
2/6
100Z ETO
Vented to out-
side ataoaphere
20
Aerator Is vented
to roo« ataosphere.
Sterilization is
conducted in the
Lahalation Ther-
apy (Technical
Service)
tepartaent.
Sterilisation work
area uasurea
16* x 11" * 18'.
Bate of air ex-
change is 7 air
changes per hour.
)lrection of air-
flow is through
Bteaa sterilizer
venting systea.
Work area equipped
with 10 open shell
unit8.
-------
T1HK C-L (C0STISUH1)
0
1
CO
oo
Sterilisation/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
SUe (ft3)/
Age (years)
Sterilant
Used
Gas Removal
Syst«»
Total
Number of
Operator#4
Potential
Exposure Situations
Equipment
Design
Workplace
Design^
Work
Practice*0
Monitoring of
Workplace for Residual
Levels of E70c
Minnesota
Site E
Castle (3045)/
8/not available
12Z ETC
8SJ Frepn®
Exhausted to
sewer.
3
Operator stands be-
hind door cracked at.
the aid of cycle.
Multiple post-
vacuums
Aerator vented to
celling.
Sterilization
conducted in
Central Supply.
Central Supply
area measures
20* x* 20* 80'.
Access to sterilization area
is limited to ETO sterilisa-
tion workers.
At "tv* of cycle, door is
cracked 2 inches for IS
minutes with operator stand-
ing behind the door.
Operator wears gloves when
transferring materials to
aerator.
In-service training is given
to operators.
Hospital maintains PMA con-
tract with manufacturer;
maintenance also performed
by hospital and Insurance
company*
St. Paul Insurance
Company tests ETO
leakage levels every
6 months using Miran
103 Infrared Analyser
and DuPoot low flow
pumps and charcoal
tubes. Highest value
of 12.5 ppm was de-
tected during exhaust
phase in rear area of
sterilizer.
Appropriation will be
made in 77 1981 for
drawing venting pipe
from aerator to out-
side and modifying
gas unit for venting
ETO in response to
data obtained from
monitoring.
-------
TABLE C-t (COBTtlllED)
0
1
u>
vO
Sterilisation/Fumigation Equipment
Control Measures lapleaented
State/
Site
Equipment
Manufacturer/
Six (ft3)/
Age (years)
Sterilant
Dsed
Cm Removal
System
Total
Elumber of
Operator**
Potential
Exposure Situation*
Equlpsttnt
Design
Workplace
Design^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
Missouri
AHSCO/
24/3
121 BTO
88Z FreoiP
Exhausted to
floor drain.
5
Sot available.
Aerator vented
directly to out-
side atmosphere.
Central Supply
area devoted
strictly to the
reprocessing of
items for steri-
sterlllcation.
Mechanical area
ventilation with
14-16 air changes
per hour.
Vents above
steriliser pull
air directly into
the aqnlpsat
room or through
the positive and
negative flow to
the decoatamina-
tlon ares*
Central Supply
has its own air-
conditioning and
heating system
which is vented
directly to the
outside atao-
sphere for pa-
tient protection.
Two open shelf
units and one
¦echanlcal aera-
tor available for
aeration.
Limited access to ETO work
area.
Workers follow AHACSP guide-
lines for chaaber and aerator
operations.
Gloves are optional and caps
are required when handling
ETO iteas.
All sterilizers are on main-
tenance prograa with
manufacturer.
Technicians provided with
check-off sheet for ETO
sterilisation operation*.
Technicians that are pregnant
cannot work in sterilization
ares.
As a result of monitoring,
several changes in ETO opera-
tions have occurred,
including;
1. The following of AHACSP
recommendations
2. Movement of ETO sterili-
sation to a new area with
a better venting system
aad aev equipment
3. Start of routine main-
tenance and accurate
keeping of those records
4. Event of routine itt-ser-
vice program on ETO
sterilization annually
5. Start of in-service
check-off sheets for ac-
curate recording of what
is learned and retained
so vague points can be
covered.
Monitoring is con-
ducted every other
month with the use of
a Draeger Multi-gas
detector. Testing Is
done during the cycle
and immediately after
the cycle at the
floor drain, chamber
drain, connection
from the ETO tank to
the steriliser, and
the area immediately
outside the door at
the time the door is
opened. Only zero
levels of ETO concen-
trations have been
detected.
-------
TABLE C-l (CQBTIKIH))
o
t
-P-
o
Sterilisation/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Sice (ft3)/
Age (years)
Sterilant
Used
Cas Removal
System
Total
Number of
Operator*®
Potential
Exposure Situations
Equipment
Design
Workplace
Design1*
Work
Practices0
Monitoring of
Workplace for Residual
Levels of fTTOc
Montana
AMSCO (2025)/
8.7/5
12Z ETO
8BX Freorr
Continuous
purge via hose
to sewer and
rented to out-
side atmosphere.
4
Worker training cm
ETO sterilization
procedures la not
provided.
There la oo regularly
scheduled program of
equipment inspection
and maintenance.
Aerator vented to
outside atmosphere
Sterilization
conducted in room
that is part of
Central Supply.
Dimensions of
room are
12' * 8* x 8'.
Passive area
ventilation<
Access to ETO work area is
limited to sterilization
workers.
Chamber door is cracked open
for approximately 5 minutes
before treated material is
removed and placed in aerator
Operators wear cotton gloves
when transferring treated
material to aerator; treated
material carried in wire
tasket.
None
-------
TABLE C-l (CWnHBl)
State/
Site
Sterilixation/Fualgatioa Equtpettt
Total
Number of
Operator*3
Potential
Exposure Situations
Control Measures Implemented
Monitoriog of
Vorkplace for Residual
Levels of ETO0
Equipment
Manufacturer/
Site (ft3>/
Age (years)
Sterilsnt
Used
Gee Removal
System
Equipment
Design
Workplace
Design^
Work
Practices0
Heir Hampshire
AMSCO
(Cryotherm) /
8/10
121 ETO
881 Freon®
Vented to out-
side atmosphere
19c
Access to sterilisa-
tion area is not
limited to ETO steri-
lization operators.
Aerator vented to
putslde staosphere.
Sterilization
conducted in
Central Supply.
Central Supply
seasures 2458 sq.
ft.
Mechanical area
rantllation (cell-
Lag ducts) vith
L0 sir changes
per hour.
Direction of air-
flow Is to ETO
work area frosi
general work area.
At end of cycle, chamber door
is cracked open.
Operators wear gloves.
ETO sterilisation procedures
discussed in procedure manual
provided to employees.
In-house maintenance of
sterilisers and ventilation
system, vith dsily checks.
Central Supply evalu-
ated for residual ETO
levels by Technology
in Medicine, Inc.
(Newton Upper Falls,
MO.) in Feb. 1980.
Firm used Wilks-Miran
1A Analyser to monitor
and reeovended that
Central Supply improve
ETO tank restraints
and correct one tank
system leak.
-------
TABLK C-l (CONTINUED)
Sterilization/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Gas Removal
System
Total
Number of
Operators®
Potential
Exposure Situations
Equipment
Design
Workplace
Design^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ET0C
New Jersey
3M Sterivac 202/
2/6
100* ETO
Exhausted via
copper pipe
to outside
atmosphere.
2
Not available-
Aerator vented to
outside atmosphere.
Chamber located
in Central Supply
Central Supply
area is
50' * 30' 10'. ETO
work space is
8' x 6' x 10'.
Mechanical venti-
lation of general^
work area with
10 air changes
in room per hour.
Direction of air
flow is from ETO
work area towards
non-ETO work area.
Limited access to ETO work
area.
Chamber door opened for 15
minutes before removing
sterilized articles.
Gloves available for workers.
Workers receive ETO orienta-
tion and written test.
Contract with 3M for semi-
annual preventative main-
tenance plan.
Monitored in March
1979 by Biomedical
Engineering Shared
Technology (BEST).
B£ST reported that:
A residual of ETO
from the previous
day's use was de-
tected in the steri-
lizer. Gas inside
sterilizer was moni-
tored for about 30
minutes with door
open, was recorded
at 16 ppm maximum,
and reduced to zero
in 30 minutes. Level
in room was zero and
air circulation sys-
tem quickly diluted
ETO level in work
area even with the
sterilizer door open
During unloading of
the sterilizer a
maximum of 92 ppm was
measured at top left
of sterilizer. Pro-
cedure used in
loading and unloading
was good and the con-
trol of personnel
and timing of loading
and unloading cycle
reduced personnel
exposure to a mini-
mum. Levels of 73
ppm for 15 minutes
and 50 ppm for a
work djv were not
reached.
-------
TABLE C-l {CONTINUED)
n
i
U>
State/
Sice
Sterillcati
oo/Fumlgatioo Equipment
Total
Nuaber of
Operators3
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOc
Equipment
Manufacturer/
Size (ft3)/
Age (yean)
Sterilant
Used
Gat Removal
System
Potential
Exposure Situations
Equipment
Design
Workplace
Design'3
Work
Practices0
New York
Site A
AMSCO
(Medallion) /
20/<2
121 ETO
881 Freon®
Vented to
sewer.
6
Not available.
Multiple post-
/acuuB.
Two air purges.
Chamber equipped
with safety lock
to preventing
opening of door
until cycle is
complete.
Aerator vented to
oucside atmosphere.
Sterilization
conducted in
separate room
(10' x 8' x 8')
located off
general work area
of Central Supply.
Passive area
ventilation.
Filtered air from
open window novas
to exhaust grill
located in
ceiling over
6terilizer.
Direction of air-
flow is from non-
ETO work area to
ETO work area.
Access to ETO work area
limited to ETO sterilization
workers.
At end of cycle, operator
opens door approximately 6
inches and leaves room for
15 minutes before removing
treated materials from
chamber.
Operator wears cotton mitts
to remove treated materials
from sterilizer and place
them in aerator; mitts are
also placed in aerator.
All employees who will oper-
ate ETO sterilizer and aera-
tor have thorough in-service
training by Central Supply
Supervisor.
Hospital maintains routine
inspection and maintenance
contract with AMSCO.
Biomedical and Engi-
neering Shared Tech-
nology (BEST) moni-
tored sterilizer in
October 1979; BEST re-
ported that facility
design and equipment
installation is good
and room circulation
is adequate. Ad-
ditional data were
not available.
-------
TABLE C-l (CONTINUED)
Sterilization/Fumigation Equipment
Control Measures Implemented
State/
Site
K^ui patent
Manufacturer/
Size (H3}/
Ajje (years')
Sterilant
Used
Gas Removal
System
Total
Number of
Operators3
Potential
Exposure Situations
Equipment
Design
Workplace
Design^3
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETO1-
N«*w York
Site R
AMSCO/
24/5
12% ETO
88?: Freon®
Vented to
sewer.
5
Not available.
AMSCO aerators (2)
vented to outside
atmosphere.
Sterilization
conducted in
Central Service
(36* x 52' x 8').
Mechanical area
Access to ETO work area is
limited to ETO sterilization
workers.
At end of cycle, chamber
door is opened for 10 minute
Monitoring of work-
place was conducted
with Wilks-Miran ^as
analyzer.
iM (202)/
2/6
100Z ETO
Vented to out-
side atmosphere.
One post-vaccum.
3M aerator
vented to room
atmosphere.
ventilation with
10 air changes
per hour.
Direction of air-
flow is from ETO
work area to
decontamination
area (nor-ETO
work area).
before treated materials are
removed from chamber. During
these 10 minutes, technicians
stay out of ETO work area.
Technicians wear gloves when
removing treated materials
from sterilizer and placing
them on loader carts. Gloves
are discarded after each use
Loader cart is pulled to
aerator.
Regular in-service training
on ETO procedures provided
for 1 full-time and 4 rotat-
ing technicians.
Hosoltal engineering staff
usually inspects equipment
on monthly basis.
It was discovered that
ETO was in the atmo-
sphere during the ex-
haust to the sewer of
the AMSCO Medallion
M unit.
-------
TABLE C-l (CONTINUED)
n
i
Ui
State/
Site
Srerilization/Fumigatioa Equipment
Total
Number of
Operators3
Potential
Exposure Situation*
Control Measures Implemented
Monitoring of
Workplace for rft-s i Jua 1
Levels of ET0c
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Cas Removal
Systen
Equipment
Design
Workplace
De»lgnb
Work
Practices0
New York
Site C
Caaele (6060)/
70/3
121 ETO
SSI Freon®
Vented to
2-3
Not available.
Multiple post-
vacuum.
Chamber equipped
with Interlock to
prevent opening
door prior to com-
pletion of cycle
aad with automatic
door.
Aerator vented to
outside atmosphere
Sterilization
conducted in
Central Supply
(50' * 30' * 8'X
Rate of air ex-
changes is IB air
changes per hour.
Direction of air-
flow is from noo*
ETO work area to
ETO work area.
Access to ETO sterilization
area, limited to sterilization
workers.
At end of cycle, operators
wear gloves while immediately
unloading chamber and pulling
cart (containing treated
materials) to aerator.
Operators receive on-the-job
training and view Castle
training program on cassettes.
These procedures are reviewed
with all employees at least
yearly and usually more
frequently.
Regular Inspection and pro-
tective maintenance performed
by outside contractor.
None
-------
TABLE C-l (CONTINUED)
State/
Site
Sceriliracion/Fuolgatioo Equipment
Total
Number of
Operators®
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0C
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Stecllant
Used
Gas Removal
System
Equipment
Design
Workplace
Design^
Work
Practices0
New York
Site D
Castle/
25/6
(400)/
VI
122 ETO
881 Freon®
Vented to
sever.
6
Not available.
Chamber equipped
with automatic
door.
Sterilization
conducted in
Central Service.
(16' x 16' x
Mechancial area
ventilation with
10 air changes
per hour.
Direction of air-
flow is to ETO
work area from
uon-fc ill wort
area.
Access to ETO sterilization
area limited to ETO sterili-
zation workers.
At end of sterilization cycle,
chamber door is opened 6
inches and the ETO steriliza-
tion room is evacuated for 15
minutes.
Items transferred to aerator
in wire baskets. Operators
iwear rubber gloves (OSHA ap-
proved) snd rubb-er sleeves
when transferring treated
materials to aerator and wear
respirator mask when entering
aerator.
Employee training is a three
step process: new employees
receive a documented and
formal one-month orientation,
then are placed in a "buddy"
system (where new employees
work along with experienced
employees), and finally are
placed on a 3-month proba-
tionary period.
Hospital has contract main-
tenance program for monthly
inspection and service.
Air sampling inspec-
tion conducted by
OSHA. Found air
samples of ETO con-
centrations to be
less than 50 ppm.
Hospital has purchaser
Draeger Model 31 hand
model for air sam-
pling; hospital now
conducts monthly sam-
pling of sterilizers
and aerator.
1002 ETO
Vented to out-
side atmosphere.
Not available.
Chamber equipped
with continuous
purge system.
Aerator vented
to outside
atmosphere.
-------
TABLE C-l (CONTINUED)
0
1
.>
Sterilisation/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Gat Removal
System
Total
Number of
Operator*4
Potential
Exposure Situation*
Equipment
Deslgn
Workplace
Design^
Uork
Practlcesc
Monitoring of
Workplace for Residual
Levels of ETOc
New York
Sice E
[2) Castle
[double door com-
bination steaa/
ETO)/
70/not available
122 ETO
88Z Freon®
Vacuus exhaust
via liquid/gas
separator to
sewer and
atmosphere.
2
Not available.
Pulsating post-
vacuua.
Liquid/gas separa-
tor at drain con-
lected to negative
pressure dedicated
exhaust system.
Pressure relief
valve vented to
atmosphere.
Jail joints in-
stalled in ETO gas
supply lines to
ninioite length of
line requiring
sleeding.
Sterilizer locatec
between prepara-
tion area and
:lean storage
area; each area
neasures approxi-
nately 50' x 501.
Sterilizer equip-
ment area and ETO
cylinder storage
area enclosed and
vented to dedi-
cated, negative
pressure exhaust
system.
Exhaust grilles
located at door
opening near flooi
level; direct air-
flow into equip-
ment area.
Rate of air ex-
change is greater
than 10 air
changes per hour.
Uork stations
located in pre-
paration area
avay f ron
sterilizers.
Eye wash statloo
located in
cylinder storage
area.
ETO sterilization conducted
only during night shift, witt
1 of 2 operators on duty.
At end of cycle, chamber
opened inmediately and cart
is pulled directly to
aerator.
Operator wears gloves during
unloading and transfer
operation.
Operators undergo training
program.
In event of leak, operator
instructed to leave area and
notify supervisor.
Sterilization and aeration
equipment inspected and ser-
viced under preventive main-
tenance program.
Monitoring performed
by equipment supplier;
resulted in installed
modifications.
Weekly spot monitoring
performed with Drae^i
colorimetrie tubes.
Hospital is consider-
ing purchase of
Wllks-Mlran portable
IB monitor.
-------
TABLE C-L (CONTINUED)
S'erilteat Ion/Fuplgatioa Equipment
Control Measures Inplenented
State/
Site
Equipment
Manufscturec/
Size (ft3)/
Age (years)
Sterilant
Used
Gas Reaoval
Systea
Total
Nuaber of
Operators3
Potential
Exposure Situations
Equipment
Design
Workplace
Des ign^
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
North Carolina
Sice A
AMSCO
(Medallion)/
24/ 1
m ETO
88Z Freori®
Vented to out-
side ataosphere-
5
Not available.
Pulsating post-
vacuus.
Aerator vented
to outside
atnosphere.
Sterilization
conducted in
Central Supply
(270 ft2).
Passive area
ventilation with
10 air changes
in room per hour.
Direction of air-
flow is towards
ETO work area
from non~ET0
areas.
Access to ETO work area
limited to ETO sterilization
workers.
At end of cycle, chamber
door is onened at least 6
inches for a 15 minute
period.
Workers wear protective
gloves when transferring
treated materials to aerator
from sterilizer.
Regular in-service training
problems for vorkers are
conducted on ETO process, in-
cluding safety factors and
hazards.
Hospital has PMA with AMSCO
for inspection and service.
Sample analysis with
gas chromatography
was performed for
hosDital by Occupa-
tional Health Branch
Laboratory (Raleigh,
N.C.)
Personnel and station-
ary air samples were
collected and indi-
cated minimal worker
exposure to ETO during
regular ETO steriliza-
tion procedures.
Levels of ETO detected
were <2.0 ppm during
personnel sampling,
<2.0 ppm during sta-
tionary sampling, and
30 ppm at floor level
in equipment room ap-
proxiaately 3 inches
from ETO sterilizer
"drain."
-------
TABLE C-l (COHTINUED)
Ci
\
J>
VO
Stdte/
Site
Sterilization/Fumigation Equipment
Total
Number of
Operatora*
Potent ial
Exposure Situations
Control Measure* Implemented
Monitoring ot
Workplace for Residual
Levels of ETOc
Equipment
Manufacturer/
Size (ft3)/
Age (year*)
Ster ilant
Uaad
Cat Reaoval
Syste*
Equipment
Design
Workplace
De«ignb
Work
Practices0
North Carolina
Si te B
AMSCO
(Medallion)/
30/4
121 ETO
88Z Freon®
Vented to out-
side ataosphere
2e
Not available.
Not available.
Sterilization
conducted in
Central Supply.
Dimension of ETO
work area are
22'6" x 11'6" x
8".
Rate of air ex-
change In room is
10 air changes
per hour.
Direction of air-
flow is up to
vents.
Access to ETO work area
United to sterilization
workers.
None
AMSCO
(Medallion)/
30/18
121 ETO
881 Freon®
Mixed with vats
and exhausted ta
drain.
-------
TABLE C-l (CONTINUED)
0
1
Ul
o
State/
Site
Scerilisation/Fualgatioa Equipment
Total
Nuaber of
Operators*
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0C
Equipment
Manufacturer/
Sire (ft3)/
Age (year*)
Sterilant
U»fcd
Gas Removal
Systea
Potential
Exposure Situations
Equi potent
Design
Workplace
Design*3
Work
Practices0
Ohio
Site A
AMSCO
(Cryotherm)/
I 6.25/5
12Z ETO
881 Preon®
Mixed with wata
and exhausted tc
drain.
7
Not available.
Pulsating post-
vacuum.
Sterilization
conducted in
Central Service
(6.25 ft* steri-
lizer) and in
Surgery (2.25 ft3
sterilizer)
which measure
1600 ft^ and
300 ft2, respec-
tively.
Each ETO work
area has Mechan-
ical area venti-
lation with 10
air changes per
hour; the airflow
in each work area
is to ETO work
area from non-ETO
work area.
Access to ETO work area in
both Central Service and
Surgery is limited to steri-
lization technicians.
None
AMSCO/
2.25/15
121 ETO
881 Freon®
exhausted
:o outside
atmosphere.
6
Not available.
One post—vacuun.
-------
TABLE C-l (COHTDIUED)
0
1
Ln
State/
Site
Sterilisation/Fumigation Equipment
Total
NuAber of
Operators
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Size (ft3)/
Age (year*)
Sterilant
Used
Gas Removal
Systea
Equipment
Design
Workplace
Design
Work
Practices
Ohio
Site B
(2) AMSCO
(Medallion)/
60/8
12X ETO
88Z Preon®
Vented to out-
iside atmosphere-
/ented to out-
Bide atnosphere.
/ented to out-
side atmosphere.
8ld
w
io0-
Workers wear no
protective clothing
or equipment.
Access to all ETO
work areas is not
restricted to steri-
lization workers.
Aerators vented to
outside atmosphere
through duct wash
and fan removal.
AMSCO sterilizer:
located in Centri
Supply; work area
measures 5000 sq.
:t.; mechanical
area ventilation
[fan) with 3 air
changes per hour;
airflow directed
toward ETO work
area.
CryQthern steri-
lizer: located
in operating roan;
mechanical area
ventilation (fan)
with 10 air
changes per hour;
airflow directed
toward ETO work
area.
3M sterilizer:
located in res-
piratory therapy;
¦echanical area
ventilation (fan).
ACMI sterilizer
located In urology
clinic; dimen-
sions of ETO work
area are 12' *
121 x 10'; pas-
sive area venti-
lation with 3 air
changes per hour.
In Central Supply, chamber
door is opened for 15 minutes
(during which time operator
leaves room).
Treated material transported
to aerators (4) in baskets,
no t by h and.
Workers receive on-the-job
training in sterilization
techniques.
AMSCO unit serviced by AMSCO
under PMA agreement
(quarterly).
Wilks-Miran Analyzer
used by safety direc-
tor on a quarterly
basis. Report detec-
tion of levels rang-
ing from 5-10 ppm in
ETO work area.
Crvothero/
12/11
3M (400)/
UJl 0
12Z ETO
881 Freon®
100Z ETO
ACMI/
Table Model/
Not available
100Z ETO
iot available.
5d
-------
TABLE C-l (CONTINUED)
0
1
Ln
ro
Sferllization/Fuslgition Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Site
Age (vears)
Sterilsnt
Used
Has Removal
System
Total
Number of
Operators3
Potential
Exposure Situations
Equipment
Design
Workplace
Design^
Work
Practices'*
Monitoring of
Workplace for Residual
Levels of EI0c
Oklahoma
Site A
AMSCO/
32/5
\2X ETO
881 Freon®
Pulsating
vacuus to
sewer.
20d
No time delay between
end of cycle and
opening of door.
Workers mar no
protective equipment-
Three aerators
vented to outside
atmosphere.
Sterilization
conducted in
Central Supply
area (20' x 12'
x 10').
Mechanical area
ventilation with
15-20 air changes
per hour.
Airflow into
decontamination
area.
Access to sterilization area
is limited to ETO steriliza-
tion operators.
Treated materials (contained
in wire basket) placed in
aerator immediately after
sterilization cycle completed.
Workers receive in-service
continuous education and or-
the-job training in steriliza-
tion procedures.
AMSCO inspects and conducts
naintenance on chambers on a
daily basis or as needed.
Monitoring conducted
by air tests labor-
atory. Additional
data were not reported.
-------
TABLE C-l (CONTINUED)
State/
Sice
Sterilizatlon/Fualgatioa Equipment
Total
Number of
Operators3
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOc
Equipment
Manufacturer/
Site (ft3*/
Age (years)
Sterilant
Used
fas ReaOval
Systea
Equipment
Design
Workplace
Designb
Work
Practices'2
Oklahoma
Sice B
AMSOO
(Medallion
Cryotherm) /
8/3
12X ETO
88? Freon®
Vented to
sewer.
2
At end of steriliza-
tion cycle, enployee
opens sterilizer dooi
and lanedlately re-
trieves treated itew
and transfers then,
in a aetal basket,
onto an aeration cart
and into aeration
chaaber.
No protective cloth-
ing or equipment
worn.
Aerator vented to
access area behind
sterilizers and Into
the sever drain.
Multiple post-
vac uua.
Interlocks to pre-
vent opening of
chaaber door prlox
to £o^>letloa of
sterilization
cycle.
Purge systeas at
end of cycle.
Sterilization
conducted in a
work area within
Central Sterile
Supply.
)lmensions of
work area are
16* x 20r x 10'
and of Central
Sterile Supply
64' x 20' x 10*.
Mechanical area
ventilation with
33.7 per hour in
work area and
.5.6 in Central
Supply.
Erection of air-
flow is from noo-
!TO work area to
!T0 work area.
Access to both ETO work areas
is limited to sterilization
workers.
Workers provided with intra-
departnental training upon
orientation to department and
approximately twice a year
after that.
Hospital has maintenance con-
tract with AMSCO; also has
bio-nedlcal engineer checking
venting, air exchanges, and
other workplace and equipment
designs to be sure hospital
is following good hospital
practices recounended at ETO
workshops.
None
ACMt (GS-10)/
1.8/7
100* ETO
Dedicated ex-
haust to out-
side atmosphere.
11
Aerator vented to
access area behind
sterilizers and into
the sever drain.
Interlocks to pre-
vent opening of
chaaber door prior
to eoaipletion of
sterilization
cycle.
Purge systems at
end of cycle.
Sterilization
conducted in
Respiratory
Therapy.
Dimensions of ETO
work area are
5' x 17* x 8'.
Mechanical area
ventialtion.
Direction of air-
flow is froa ETO
work area to non-
ETO work area.
-------
TABLE C-l (CONTINUED)
State/
Site
SeerillrtttIon/Fumigation Equipment
Total
Number of
Operators3
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0C
Equipment
Manufacturer/
Sire (ft3)/
Age (years)
Sterilant
Used
Gas Removal
Systea
Equipment
Design
Workplace
Designb
Work
PractLcesc
Pennsylvania
Site A
AXSCO/
9/15
122 ETO
88X Freon®
Vented to
sewer.
3
Three aerators
vented to room
atmosphere.
Not available.
Sterilization
conducted in
Central Supply
(18* x 14' x 10")
Mechanical area
ventilation with
15 air changes
per hour.
Direction of
airflow is to-
wards ETO work
area froa non-
ETO work area.
Exhaust fans in-
stalled in gas
sterilization
area.
Access to ETO work area is
limited to ETO sterilization
workers.
At end of cycle, operator
opens chamber door and leaves
ETO work area for 15 minutes.
Treated materials are trans-
ferred from sterilizer to
aerator by using tranafer
carriage for large sterilizer
and by basket or hand for
small sterilizer.
Operator wears gloves when
removing treated materials
from small sterilizer.
Gas sterilization and aera-
tion instructions are printed
in Central Supply procedure
manual.
Quarterly inspection and
maintenance program is con-
ducted; hospital did not
specify who conducts program.
Hospital personnel
monitor gas residuals
with Draeger gas de-
tector on periodic
basis. Maximum levels
of 30 ppm to 35 ppm
were detected for ap-
proximately 15 minutes
after opening of
sterilizer door.
AMSCO/
24/6
121 ETO
881 Freon®
Vented to
sewer.
Multiple post-
vacuums .
-------
TABLE C-l (CONTINUED)
0
1
Ln
ui
State/
Site
Sterilisation/Fumigation Equipment
Total
Number of
Operators
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0c
Equipment
Manufacturer/
Site (ft3)/
Age (year*)
Sterilant
Used
Gat Removal
Systea
Equipment
Design
Workplace
Deslgnb
Work
Practices0
Pennsylvania
Site B
3H (400)/
4/6
100X ETO
(Tented to out-
side atmosphere.
3-4
Kot available.
Chambers equipped
with interlocks to
prevent opening
of door before
completion of
cycle and with
additional purge
systems.
Sterilization
conducted in Cen-
tral Processing.
General work area
measures
53' x 29* x 8'.
Hechanical area
ventilation with
10.3 air changes
>er hour.
direction of air
flow is towards
ETO work area
fron non-ETO work
area.
Access to ETO sterilisation
area limited to ETO sterili-
zation workers.
At end of cycle, operator
opens door 6 inches for 13
minutes.
Operator wears gloves when
transferring treated material
to aerator.
New employees receive in-ser-
vice education by 3M repre-
sentative; continued educa-
tion and supervision provided
by group leader.
Sterilizers Inspected and
serviced two times per year.
Eaiergency Care Research
Institute (ECRI) mea-
sured ETO levels at
hospital in December
1977. ECRI used
Wilks-Miran IA General
Purpose Infrared Gas
Analyzer to monitor.
Hospital reports that
study indicated no
evidence of excessive
exposure to personnel;
however, in response
to report, ventilation
in ETO work area was
Increased from. 6.6 to
10.3 air exchanges per
hour. No additional
data were reported.
3M (400)/
4/1
LOOX ETO
/ented to out-
side atmosphere
Not available.
Aerator vented to
outside atmosphere
-------
TABLE C-i (CONTINUED)
n
I
en
ON
Srerilizatioa/Fufllgatioo Equipment
Control Measures Implemented
State/
Site
EquipaenE
Manufactu rer/
Site
Age (years)
5ceril«ac
Used
Gmm Removal
Systea
Total
Nuxbef of
Operator#*
Potential
Exposure Situations
Equipment
Design
Workplace
Designb
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETCf
Pennsylvania
Site C
3MI
2/9
1001 ETO
Rented to out-
iide atmosphere.
13
Mot available.
Ihanbers equipped
flth Interlocks to
>revent opening of
loor before com-
Sterilization
conducted in
Central Supply
(general work area
Access to ETO work area
limited to ETO sterilization
workers.
Emergency Care Researct
Institute has evalu-
ated hospital's ETO
aeration process;
3H (200)!
2/10
100Z ETO
Rented to out-
side ataosphere.
jletion of cycle.
lerator vented to
>ucslde atmosphere.
Is 60* x 17* x
10').
Mechanical area
ventilation.
Direction of air-
flow is frois non-
ETO work area to
ETO work area.
rfork area equip-
ped with 103 open
shelf units.
At end of cycle, operator
opens chamber door and waits
15 minutes before unloading
chamber.
Operator wears neoprene gloves
when transferring treated
materials from sterilizers to
aerator.
Items that cannot withstand
mechanical aeration areplacec
on open shelf below large ex-
haust fan In ETO work area.
Operators receive extensive
in-service orientation and
review programs on ETO
procedures.
3M conducts routine main-
tenance check every 6 months
and E.C.R.I, checks equipaent
annually.
additional data were
not available.
-------
TABLE C-l (CONTINUED)
n
i
Ln
State/
Site
S'er 11isat ion/Fumigation Equipment
Total
Nuaber of
Operators*
Potential
Exposure situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOc
Equipment
Manufacturer/
Site (ft^")/
Age (years^
Sterilant
Used
(lag Reaoval
Systea
Equipment
Design
Workplace
Design15
Work
Pract icesc
South
Carolina
3M/
3. 9/4
100Z ETO
exhausted gas
?iped to outside
atmosphere.
4ot available
Three aerators vented
to room atmosphere.
Built in purge
eyeten.
Interlock to pre-
vent opening door
before end of
cycle.
Chamber and
aerators located
in Respiratory
Therapy area
(U* * 10* x 8').
Mechanical area
ventilation with
10 to 12 air
changes per hour.
Direction of air-
flow is from non-
ETO areas toward
ETO area.
Limited access to steriliza-
tion area.
At end of cycle, chamber door
Is opened and operator leaves
area for 15 minutes.
Cotton gloves worn when bas-
kets removed from chamber and
placed in areator. Face
masks are available.
Workers receive in-house
training.
ETO chamber cleaned weekly.
Maintenance done by Bio-
Medical division.
Not available.
-------
TABLE C-l (CONTIHUED)
SterlllzAtlon/FualgatioQ
Equipment
Control Measures Implemented
State/
Site
Equlpment
Manufacturer/
SUe (ft3)/
Age (years)
Sterilant
Used
Gat Removal
Systea
Total
Number of
Operator#*
Potential
Exposure Situation*
Equipment
Design
Workplace
Des lgr»k
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOc
Texas
AMSCO (621QA)/
2/14
121 ETO
88Z Freori®
Vented to out-
side atmosphere,
16
Sot available.
Pulsating post-
vacuum.
Interlocks to pre-
vent opening of
chamber door prior
to completion of
cycle.
Aerator vented to
outside atmosphere
Sterilization
conducted in
Central Supply
(general work
area 19 45' x
15' x 12').
Mechanical area
ventilation with
7 air changes
per hour.
Direction of air-
flow is to ETO
area fron non-ETC
area.
Twenty open shelf
uni ts.
Access to ETO sterilization
area Halted to sterilization
workers.
At end of cycle, chamber door
is partially opened.
Operator waits 15 minutes be-
fore transferring treated
materials from sterilizer to
open shelves-
Operator wears cotton gloves
Operators receive periodic
In-service training on opera-
tion of sterilizer and trans-
fer of treated materials to
aerator.
Sterilizer checked at least
every 3 months by "factory"
trained repairman.
None
-------
TABLE C-l (CONTINUED)
o
Ln
v£>
Sterilization/Fumigation Equipment
Control Measures Implemented
State/
Site
Equipment
Manufacturer/
Size (ft3)/
Age (year«)
Sterilant
Used
Gas Removal
System
Total
Number of
Operator*4
Potential
Exposure Sltuationa
Equipment
Design
Workplace
De*tgnb
Work
Practices41
Monitoring of
Workplace for Residual
Levels of ET0c
Virginia
Site A
AMSCO/
8/Not available
111 ETO
B8Z Freoa®
Vented to
sterilizer
maintenance
rooa.
7
Aerator vented to
sterilizer maintenance
roo®.
Multiple post-
vacuuas.
Chamber is equip-
ped with inter-
locks to prevent
opening of door
before end of
cycle.
Sterilization
conducted in
Central Supply.
Mechanical area
ventilation with
10 air changes
per hour.
Direction of air-
flow is to non-
ETO work areas
from ETO work
area.
Access to ETO work area
limited to ETO sterili-
zation workers.
Operators follow AHA guide-
lines for ETO sterilization
procedures.
Treated materials transferre
to aerator on cart.
Operators wear gloves.
New enployees are told of
principles, procedures and
hazards of ETO before they
are allowed to operate sterl
llzer or aerator. These in-
structions are reviewed
yearly.
Hospital makes quarterly
preventive maintenance
checks.
Facility was monitored
by a private company
using Wilks-Mlran 1A
General Purpose
Infrared Gas Analyzer.
TWA reported for one
sterilization cycle
was 3 ppra; the worst-
case estimated short-
term exposure level
was 27 ppm.
-------
TABLE C-l (CONTINUED)
Sterilisation/Fumigation Equipment
Control Measure* Implemented
State/
Sice
Equipment
Manufacturer/
Size (ft^V
Age (years)
Sterilant
Used
Has Renoval
System
Total
Number of
Operators a
Potential
Exposure Situations
Equipment
Design
Workplace
Design'5
Work
Practlcesc
Monitoring of
Workplace for Kesidual
Levels of ETOc
Virginia
Site B
Castle (1500)/
2/2
12Z ETO
882 Freon®
Not available.
1
Operating rooa per-
sonnel may, on occa-
sion, come to ETO work
area to pick up
supplies.
There is no regularly
scheduled program of
equipment Inspection
and maintenance.
Aerator (Castle 1550)
exhausts to rooa
atmosphere.
Not available.
Sterilization
conducted in
separate room off
of Central Supply
Mechanical area
ventilation with
20 air changes
per hour.
Direction of air-
flow is into
general building
air circulation.
Access to ETO work area is
generally limited to ETO
sterilization worker.
At end of cycle. Operator
opens door and leaves room
for 5 minutes before unloadin,
treated usterlals from steri-
lizer to aerator (materials
aerated for approximately 6
hours or overnight).
Castle provided In-house
demonstration of hov to use
ETO equipment; however, hos-
pital reports that Castle
representative did not stress
employee safeguards to pre-
vent exposure to ETO.
None
-------
TABLE C-l ( CONTINUED)
o
*
On
State/
Site
5'eriliratlon/Fumigation Equipment
Total
Number of
Operators4
Potential
Exposure Situations
Control Measures Implemented
MonitPring of
Workplace for R^sidval
Levels of ETOc
Equipment
Manufacturer/
Sice (fr3)/
Age (years^
St«rilant
Used
Gas Removal
Systea
Equipment
Design
Workplace
Des Igti^
Work
Practices0
Washington
Site A
AMSCO/
9/5
121 ETO
881 Freor^®
Not available.
14
Not available.
Chamber equipped
with interlocks
to prevent opening
of door prior to
completion of
cycle.
Aerator vented to
outside atmosphere.
Sterilization con-
tacted in Central
Jervice (128 f t^ ) .
lechanlcal area
ventilation with
12 air changes
>er hour.
Direction of air-
flow is towards
JTO work area.
Access to ETO work area
limited to ETO sterilization
workers.
At end of cycle, chamber door
id opened 6 inches for IS
minutes before treated mate-
rials are removed.
Operator wears gloves when
transferring treated materials
to aerator from sterilizer.
AMSCO salesman explained to
employees workings of steri-
lizer and aerator and pre-
cautions to be taken when
using ETO. Central Supply
workers are provided with
procedure book and ETO file
containing use guidelines*
Mew literature and informa-
tion from seminars on ETO use
are reviewed with workers.
Hospital has preventative
maintenance program with an
outside firm for monthly in-
spection and service.
Hospital central ser-
vice area was moni-
tored to nt-asure em-
ployee exposure to
ETO in March 1979 and
March 1980 by Dept. of
Environmental Health,
University of
Washington.
Harch 1979 survey:
Samples were collected
on activated charcoal
and analyzed by gas
chromatography as
recommended by Quazi
Ketchum method. This
survey did not detect
any concentrations of
ETO on top of steri-
lizer, on floor in
back of steriliser In
separate room, across
room from sterilizer,
and on main work bench.
March 1980 survey:
Samples were collected
using low-flow pumps
and activated carbon
adsorption tubes. This
survey detected ETO
levels of 2.7 ppn in
Central Supply above
sterilizer, and no
concentrations of ETO
at Central Supply on
table in middle of
roots or at Central
Supply on bench 10 ft.
from sterilizer.
-------
TABLE C-l (CONTINUED)
n
I
Ster11iration/Fuoigatioo Equipment
Control Measures Id
plemented
State/
Site
Equipment
Manufacturer/
Sire (ft3)/
Age (years)
Sterllant
Used
Gas Keaoval
System
Total
Number of
Operators®
Potential
Exposure Situations
Equipment
Design
Workplace
Design'5
Work
Practices'2
Monitoring of
Workplace for Residual
Levels of ETOC
Hashingcon
Sice A
(Concluded)
It should be noted
that the Washington
State Industrial
Safety and Health Act
has set permissable
exposure level (PEL)
for ETO at 50 ppm.
The PEL refers to the
concentration a person
may be safely exposed
to 8-10 hours per day
within a 40-hour week
without adverse
affects to health.
-------
TABLE C-l (CONTINUED)
Sterilisation/Fumigation Equipment
Control Measure# Implemented
State/
Site
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilanc
Used
Gas Reaoval
Systea
Total
Nuaber of
Opera tors*
Potential
Exposure Situation*
Equipment
Design
Workplace
Dealgtjb
Work
Praeticesc
Monitoring of
Workplace for Residual
Levels of ETOc
Washington
Site B
A.MSCO/
40/4
1ZZ BTO
S8Z Freon®
Vented to out-
side atmosphere
13
Not available.
Multiple post-
vacuuas.
Aerator vented to
outside atmosphere.
Sterilization
conducted In
Central Supoly
(20* x 8^' x 8').
Passive area ven-
tilation with 10-
12 air changes
per hour.
Direction of air-
flow is towards
BTO work area.
Acce88 to ETO work area
limited to ETO sterilization
workers.
At end of cycle, chamber door
Is cracked open 6 inches and
the area is vacated for 15-
20 minutes while ETO gas
dissipates.
Operator wears latex gloves
and scrub suit to pull steri-
lizer cage out of chamber ane
place directly into aerator
(so that none of the treated
materials need to be handled).
ETO work procedures and
training are updated as new
recoomendations are made by
A.A.M.I., and other groups.
Operators receive 6-to 6-week
training program covering all
areas of sterilization.
Hospital has preventive main-
tenance agreement with AMSCO
for bimonthly inspection and
service.
None
-------
TABLE C-L (CONTINUED)
State/
Site
Srerlliration/Fumlgatioo Equipment
Equipment
Manufacturer/
Size (ft3)/
Age (years)
Steri tanc
Used
Gas Removal
Systeai
Total
Number of
Operators*
Potential
Exposure Situations
Control Measures Implemented
Equipment
Design
Workplace
Des ign*1
Work
Practices0
Monitoring of
Workplace for Residual
Levels of ETOC
Washington.
D.C.
(3) Castle/
11, 12. <12/
<2
121 ETO
88Z Freon®
Vented to
drain.
Access to ETO steri-
lizeration area Is
not restricted to
sterilizer operators.
Pulsating post-
vacuum .
Aerators vented to
outside atmosphere
through dedicated
exhaust.
Sterilization
conducted in
Central Supply.
Ceiling exhaust
vents located
above loading
door, unloading
door and recessc<
equipment area.
Direction of air-
flow is from non-
ETO to ETO work
area.
At end of cvcle, operator
opens door for 15 minutes be-
fore unloading treated mate-
rials from chamber.
Operators transfer treated
materials in baskets to (4)
aerators.
erators wear cotton gloves
and goggles. Gloves are
placed In aerator after use.
Operators receive in-house
training in ETO sterilisation
techniques.
Equipment undergoes monthly
inspection and maintenance.
Medical examinations have
been performed on all 32 per-
sonnel (ETO sterilizer opera-
tors, maintenance personnel,
and monitoring personnel) in
Central Supply.
Hospital moni tored
ETO work area to
evaluate effectiveness
of pulsating poat-
vacuuu modification to
,2 Castle chambers,
using Wilks-Miran 10J
infrared gas analyzer
at 6 inches from steri-
lizer door and at
shoulder height.
Immediately upon door
opening, peak ETO con-
centrations were 18
ppm. Within 7 and 15
minutes, levels had
dropped to 15 ppm and
3 ppm, respectively.
Other changes made to
equipment as a result
of data obtained from
monitoring include
sealing of the drain
and venting of ^as
through a dedicated
exhaust Co the outside
atmosphere and Instal-
lation of a reducer In
the exhaust line to
slow the rate of water
released from the
chamber.
-------
TABLE C-i (CONTINUED)
State/
Site
Snerlliztcton/FuBlgacioo Equipment
Total
Number of
Operators*
Potential
Exposure Situations
Control Measures Implemented
Equipment
Manufac turer/
Size (ft-')/
Age (years)
Sterilant
Used
Gas Reaoval
Systes
Equipment
Design
Workplace
Design^
Work
Practices'^
Monitoring of
Workplace for Residual
Levels of L"10c
Wisconsin
Site A
3H (202)/
2/2
100Z ETO
Vented through
copper tube
to outside
atmosphere.
6
Not available.
Two aerators
vented to outside
atnosphere.
Sterilization
conducted In
sterilizer room
of Central
Service.
Sterilizer room
measures 19*3" x
8' * 8*.
Mechanical area
ventilation with
air movement of
750 cfm.f
Direction of air-
flow is to ETO
work area from
non-ETO work
area.
Access to ETO sterilization
room limited to ETO steri-
lization workers.
At end of cycle, chamber door
Is cracked open for a 10-
ainute period before treated
materials are removed.
Operator wears disposable
latex exam gloves when trans-
ferring treated materials (in
sterilizer basket) from
sterilizer to aerator; if
ambient aeration is required
treated materials are placed
on counter top away from
main work area where they
remain undisturbed for 1
week.
Workers receive orientation
training and yearly review
which focus on task mastery
of sterilization and aeratior
procedures.
Hospital has preventive
maintenance contract with 3M
for both sterilizers and
aerators.
Hospital's Director
of Building Services
and a laboratory
toxicologist monitor
ETO work area every
6 months.
Draeger Model 31,
V-100 cm^ with
Athyleroxide 25/a
tubes,, used to monitor
ETO levels at the
door of the steri-
lizer as it Is opened
at the completion of
a cycle; hospital
reports that gas
levels were below the
"measurable amount."
Additional data were
not supplied.
3M (400)7 1
4/3
1002 ETO
Vented through
copper tube
to outside
atmosphere.
-------
TABLE C-l (CONTINUED)
n
I
&
ON
State/
Site
Sterilization/Fumigation Equipment
Total
Nuober of
Operators8
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOc
Equipment
Manufacturer/
Size (ft3)/
Age (years)
Sterilanc
Used
Gas Removal
Systea
Equipment
Design
Workplace
Design^
Work
Practices0
Wlsconsin
Site B
AMSCO (65GM)/
36/4
121 ETO
881 Freon®
Vented to out-
»ide atmosphere.
3
Access to ETO sterili-
zation area is not
United to steriliza-
tion workers and in-
cludes general hospi-
tal personnel.
Multiple post-
vacuums.
Chaaber equipped
with interlock to
prevent opening
of door prior to
completion of
cycle.
Aerator vented to
outside ataospherc
via duct work.
Sterilization
conducted in
Central Supply
(27' x 21' x 18').
Mechanical area
ventilation with
10 air changes
per hour
Direction of air-
flow is from non-
ETO area to ETO
area.
At end of cycle, door is
opened about 3 inches for
20 minutes before treated
materials are removed.
Operators wear cloth gloves
when transferring treated
materials (in basket) frota
sterilizer to aerator and
when removing treated mate-
rials from aerator and
placing on open shelf units.
Sterilization workers receive
in-service program on ETO
procedures for 3 months and
operating instructions in a
policy and procedures work
book, and can find list of
procedures to deal with
equipment malfunctions postec
next to sterilizer.
Sterilizers are checked daily
(in-house) and Plant Opera-
tions exchanges all tanks
and monitors all ETO lines
daily.
None
-------
TABLE C-l (CONTUHJED)
State/
Site
Sterilization/Fumigation Equipment
Total
Number of
Operators3
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0C
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Cat Removal
System
Potential
Exposure Situations
Equipment
Design
Workplace
De»ignb
Work
Practices0
State not
labeled
Site A
AMSCO/
12/14
12Z ETO
S8Z Freonf8
Vented to out-
side atmosphere
2
Not available.
Overhead hoods
located above
sterilizers.
Aerator vented to
Outside atmosphere<
Sterilization
conducted in
corner of Central
Supply.
Central Supply
measures 20' x
5' * 10'.
Direction of air-
flow is towards
ETO work area.
Access co ETO work area
Halted to sterilization
workers.
At end of cycle, chamber doer
is cracked open and personnel
avoid ETO work area; operator
waits 15 minutes before un-
loading chamber.
Operator wears cloth gloves
when transferring treated
material from sterilizer
to small cart to aerator.
Personnel required to take
in-service training before
they are allowed to use ETO
sterilizer. Review sessions
on ETO procedures held every
6 months.
Hospital contracts with
AMSCO for regularly schedule<
program of equipment service
and maintenance.
As of August 1980,
Central Supply area
was being renovated.
In October 1980, new
work area will be
monitored.
AMSCO Eagle/
12/<1
122 ETO
881 Freon®
Vented to out-
side atmosphere.
-------
TABLE C-l (CONTINUED)
0
1
CT>
oo
Steriliratlon/Fumigatioa Equipment
Control Measures Implemented
State/
Site
Equipment
Hinufacturec/
Size (ft31/
Age (years)
Sterilant
Used
Gas Removal
System
Total
Number of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Des ign^
Work
Pract icesc
Monitoring of
Workplace for Residual
Levels of ET0C
State not
labeled
Site B
Castle (4060)/
60/5
12Z ETO
881 Freon®
/ented to sever
irain and to
atmosphere.
There is no regularly
scheduled program of
equipment inspection
and maintenance.
[>ne post-vacuum.
Chamber equipped
with automatic
doors; Interlocks
to prevent opening
jf chamber door
prior to completicr
of cycle; and ini-
tiated procedure
to abort cycle.
Additional purge
cycles are bud-
geted for
installation.
Liquid/gas separa-
tor at 9ewer drain.
rvo aerators
vented to outside
atmosphere.
Sterilization
conducted in
Central Supply.
Sterilizer entry
area measures
27' x 33' x 9';
sterilizer exit
area neasures
33' x 48' x 9'.
Passive area ven-
tilation with 6-
10 air changes
per hour.
Direction of air-
flow is from ETO
work area in
sterilizer entry
area and to ETO
work area in
sterilizer exit
area.
Hooded area above
sterilizer doors
vented to outside
atmosphere.
Access to ETO work area
limited to ETO sterilization
workers.
At end of cycle, door is
automatically opened and any
residual chamber gases are
allowed to vent to hood above
sterilizer for approximately
10 minutes.
Operator wears cotton gloves
when removing carts from
sterilizer and placing them
into aerator (approximately
6 ft. away).
In-house training programs
offered each year. On-the-
job training includes litera-
ture from AAM1 and ASHCSP
standards for E.O. in hospi-
tals and attendance at out-
side seminars conducted by
AMSCO, ASHCSP, IAHCSP, and
CCST.
Hospital safety
department used Wilks-
Mlrari Vapor Analyzer
to monitor sterilizers.
Only specific problem
noted in 5 years is
possibility of gas
leakage during pres-
surization at begin-
ning of sterilization
cycle. This is moni-
tored with Draeger
gas detector.
Periodlcally monitor
area around open door
at completion of cycle.
-------
TABLE C-l (CONCLUDED)
Refers to the total number of persons authorized to operate ETO sterilization equipment at this
facility unless otherwise indicated.
'where indicated, the dimensions of ETO work areas represent length x width x height.
Data in this column apply to all ETO sterilizers, ETO work areas, or ETO sterilizer operators
at this facility.
Srhe total number of operators reported by this facility may include general hospital personnel
or other employees in the ETO work area.
'The total number of operators reported by this facility represents the number of operators per
shif t.
This represents cubic feet per minute (cfm).
-------
TABLE C-2
PRACTICES RELATIVE TO WORKER EXPOSURE .AT
SELECTED MEDICAL PRODUCTS INDUSTRY SITES
Sterilization/Fumigation Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
Ster llant
Used
Gas Removal
Sys ten
Total
biuaber of
Operatorsa'b
Potential
Exposure Situations^
Equipment
Des ign
Workplace
Design^'*"
Work
Pract ices"
Monitoring of
Workplace for Residual
Levels of ETC^1
Site A
(2) 1200
122 ETO
88% Freon®'
Vented to
outside of
building.
1 -k
Operators must enter
chamber to unload
treated materials.
Access to ETO steri-
lization area is not
limited to ETO steri-
lization workers;
other personnel may
be in ETO work area.
Chamber equipped
with positive
pressure air wash
which operates
prior to opening
of chamber.
Sterilization
conducted in
25 ,900 ft2
general warehouse
wi th 30 t t . high
re iling?.
ventilation
(i ans "> .
Rate of air ex-
change is. j 000
cfm.°
Direction of air-
flow is towards
ETO s teri]i zer
pit.
Operators wear fas nask = when
unloading chamber.
Operators receive briefings
on procedures to be utilized
in sterilization process.
Rt?gularlv scheduled protirarr.
of equipment inspection and
maintenance, including, steri-
1 i zer vali dat ion.
Work area monitored
for environmental
levels of ETO using
gas chromatography.
In response to data
obtained from such
monitoring, i*<- o: :as
masks was initiated
and tho ;vrird o; air
wash was lengthened.
Less than J pom per
day has been detected
with Ras chromatog-
raphy monitoring since
controls have been
imp j emented.
-------
TABLE C-2 (CONTINUED)
o
Facility
Sterilization/Fumigation Equipment
Total
Number of
Operator*®^
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Size of
Sterilizer
(ft3)
Sterllant
Used
Gas Removal
Systea
Potential
Exposure Situations^
Equipment
Design
Workplace
Designee
Work
Practices'5
Site B
115
12X ETO
8SZ Freon®
Vacuia pump
exhaust through
roof.
1-4
(Operators
are respon-
sible for
loading, gas-
sing, vent-
ing, purging,
and mloadinj
the
sterilizers).
Operators oust enter
large sterilizer to
unload treated
materials.
Each sterilizer
performs 2 air
purges and 1-hour
continuous purge
before opening of
chamber doors.
115 ft3 sterilizer
equipped vith
gasketed double
door.
32 ft3 sterilizer
equipped with gas-
ket ed door.
Aerators, used for
treated materials
froa snail ster-
ilizer, are
exhausted to
outside atmosphere-
115 ft3 steri-
lizer, treatment
Is conducted in e
separate work
area (20* * 1?'
x 12') equipped
with 10 air
changes per hour.
32 ft3 aterl-
lizer, treatment
is conducted in
the general work
area (50' x 12'
x 8*) equipped
with 8 air changes
per hour.
In each area,
there Is mechani-
cal area vent na-
tion and the
direction of air-
flow is towards
ETO area from
non-ETO area.
Aeration room has
its own air sys-
tem; makeup air
is outside air
and exhaust is to
atmosphere.
Access to ETO sterilization
area restricted to authorizes
personnel.
At end of cycle, chamber door
is cracked open and personnel
leave area for 30 minutes.
Operators wear goggles and
gloves when unloading
sterilizers.
Treated materials are placed
on stainless steel carts and
moved to aeration room or
aerator. Large sterilizer
opens to aeration room-
Workers are trained by super-
visors on operation of
equipment and loading and un-
loading. Supervisors also
oversee unloading procedures
of new workers for several
weeks before new workers are
allowed to operate equip-
ment on their own.
Equipment is inspected and
maintenance work is performed
every three months. Instru-
ments are recalibrated if
necessary.
Personnel monitors
have been used on em-
ployees during un-
loading process.
Chambers have been
analyzed for ETO con-
tent after purging but
before opening.
Treated materials have
been analyzed for
residual ETO with gas
chromatography.
Monitoring data were
not reported.
32
IIt ETO
881 Freon®
Vacuimi puop
exhaust through
room.
-------
TABLE C-2 (CONTINUED)
Steriliration/Fuoigation Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
Ster ilant
Used
Gas Removal
System
Total
Number of
Operators3^
Potential
Exposure Situations'5
Equipment
Design
Workplace
Des igtib »c
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETO'3
Sice C
1100
121 ETO
88 Z Freon®
Vented to
outside
atmosphere.
1-4
(Operators
load and un-
load chamber,
monitor cy-
cle , and
retrieve
biological
indicator
samples from
load).
Operators must enter
chamber to retrieve
treated materials.
Treated materials are
manually pushed on
rollers to front of
chamber.
Workers do not wear
protective clothing
when unloading
chamber.
Two post-vacuums
and 1 air wash
drawn.
Site reports that
chamber is a self-
contained unit and
that complete
aeration occurs
prior to removal
of treated mate-
rial from chamber.
Sterilization
conducted in
general work area
(100' x 50' x
40').
Passive area
ventilation.
Direction of air-
flow is both to
and from ETO
work area.
There is limited employee
traffic in sterilizer area.
At end of cycle, chamber
door is opened 6 inches for
approximately 15 minutes.
After this period, door is
completely opened and
treated materials are
retrieved,
Lift truck used to transport
treated material to storage
area.
Workers are trained on all
procedures to be utilized
in sterilization process and
are informed of potential
medical problems that result
from ETO exposure.
Inspection and maintenance
program is outlined in a
formal procedure. Monthly
checks and maintenance are
performed on door bearings
and gasket, recorder pens,
vacuum pump seals, and blow
down strainers. Semi-annual
checks and maintenance per-
formed on sterilant filters,
humidity sensors, valves,
internal paint, circulating
pump, and air in-bleed
filter. Annual checks and
maintenance performed on
ball valves, sterilant
valves, relief valves, pump
motors and vacuum pump.
Monitoring has been
performed to determine
worker exposure to ETO
during normal steri-
lizer operation.
Levels below 10 ppm
were detected with gas
chromatography.
-------
TABLE C-2 (CONTINUED)
n
i
Facility
Scerllleation/Fucnlgation Equipment
Total
Number of
Operators
Potential
Exposure Situations*5
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0b
Size of
Sterilizer
(ft3)
Sterllant
Used
Gas Removal
Systea
Equipment
Design
Workplace
Designee
Uork
Practices1*
Site D
Not applicable.
1001 ETO
121 ETO
88% Freod®
II
Hot applicable
1-4
Employees Bust enter
aeration room (for
short periods of
tine) .
Sterljet system
used to treat
materials.
Sterijet^ equipped
vith built-in
cabinet exhaust
capable of main-
taining alnlJHm
operator exposure
(typically 5 ppm
or less).
Sterilization
conducted In work
area (13* * 71
* 7').
Mechanical area
ventilation.
Rate of air
movements Is
2000 cffl»-d
Direction of air-
flow is from aon-
ETO areas towards
ETO areas.
Aeration room
vented to outside
atmosphere.
Materials moved to aeration
roon on conveyor and then
stored in stacked cardboard
boxes.
Operator work practices
governed by written pro-
cedures in accordance
with Good Manufacturing
Practices recommended by
U.S. FDA. No formal class-
room worker training program
however, training is con-
ducted by supervisors on the
job and monitored by a
bacteriologist.
There is a regularly
scheduled program of equip-
ment inspection and
maintenance in compliance
vith FDA undated Good
Manufacturing Practices.
Written test procedures and
inspection and maintenance
requirements are monitored
by computer generated oper-
ation sheets. Sheets are
logged into computer when
inspection and maintenance
is completed. Audit proce-
dures assure review of com-
pleted operation sheets.
Mlran 101 Infrared
monitors are used
to confirm ETO levels
of employee exposure,
sources of ETO which
may be released into
the workspace, and
inprovenent in
facilities. Gas
chromatography also
used.
ETO concentration In
aeration room is
typically 50 ppm
(with employee ex-
posure less than 1
hour per day, about
2 to 3 days per week).
Over past several
years levels of vozfcer
exposure have been
reduced from more
than 100 pom on oc-
casion to typically
below 10 ppm.
-------
TABLE C-2 (CONHNUED)
0
1
Sterllizatlon/Fuaigatioo Equipment
Total
Number of
Operators3*1
Potential
Exposure Situations^
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO^
Facility
Size of
Sterilizer
(ft3)
Sterilant
Used
Gas Reaoval
Systea
Equipment
Design
Workplace
De«ignb»c
Work
Pract ices'5
Sice E
400
12X ETO
88% Freon®
Vented to
atmosphere;
vacuum to
water bath.
7
Workers mist enter
sterilizer to re-
trieve treated
materials.
All 3 sterilizers
exhaust to outside
Wilkes sensors.
«00 ft3 and 700 ft?
sterilizers equip-
ped with interlocks
to prevent opening
of chamber door
before completion
of cycle. Rear
exhaust in these
2 sterilizers is
approximately 1000
cfra-d
400 ft3 and 700
ft* sterilizers,
treatment is con-
ducted in room
(30* x 30')
equipped with A3
air changes per
hour.
1300 ft3 steri-
lizer, treatment
is conducted in a
separate room
(12* x 75*)
equipped with 30
air changes per
hour.
In each ETO area,
there is mechani-
cal area ventila-
tion and the
direction of air-
flow is from ETO
area negative to
surrounding area.
Floor ventilation
located directly
under chamber
doors.
Treated material!
stored in unoc-
cupied warehouse
area.
Access to ETO sterilization
areas is semirestricted.
At end of cycle, door is
opened 6 inches for 15 min-
utes, then fully opened for
another 15 minutes before
treated materials are
retrieved-
Workers retrieve materials
by pallet load with pallet
j3ck. Workers wear goggles
and gloves when changing
gas cylinders. Respirators
are available in event of
a spill.
Workers receive formal
training program which
includes manual and video
cassettes.
Formal written maintenance
program exists for daily,
weekly, monthly, and annual
preventive maintenance.
Sterilizer areas mon-
itored 24 hours per
day using Wilk.s 1/
point IR unit. Em-
ployee air samples are
taken every 6 months
at breathing zone usinj
air pumps. Facility
reports that levels
are <10 ppm except for
chamber entry, which
is 25—45 ppm.
Procedure and process
changes have been made
in past 2 years in re-
sponse to data
obtained from mon-
itoring. Latest
changes include in-
terior ventilation
during unloading
process and post con-
ditioning chambers.
700
12\ ETO
881 Freon®
Vented to
atmosphere;
vacuum to
water bath.
1300
12* ETO
88Z Freor.®
100Z ETO
Pulsing stean
ejector to
outside
atmosphere.
-------
TABLE C-2 (CONTINUED)
n
I
Ln
Sterilizatioa/Fumigatioa Equipment
Total
Number of
Operator****
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO^
Facility
Size of
Sterilizer
(ft3)
Sterilsnt
U«ed
Cat Removal
System
Potential
Exposure Situation^3
Equipment
Design
Workplace
Designee
Work
Practices^
Site F
195
121 ETO
88Z Freon®
Vacuus system
to water
system.
1-4
Operator mist enter
chamber to remove
product load.
External exhaust
located at front
and rear of chas-
ter; exhausted to
outside atnosphere.
Internal exhaust
system at rear
of sterilizer*
Sterilizer equip-
ped with vacuus
system connected
to recirculation
water system.
1
155 ft3 steri-
lizer is located
in a separate
room (14' x 36' x
2Cf) with air ex-
change of 1200
cfm^.
540 ft3 steri-
lizer Is located
in a separate
room (32* x 27' x
14') with a rate
of air exchange
of 1200 cfm.d
In both ETO work
areas there is
aechanlcal area
ventilation (cir-
culation fan) aiu!
the direction of
airflow is from
FTJ work *rea to
non-ETO work
area.
Access to ETO work areas is
restricted to authorized per-
sonnel.
At end of cycle, a check is
made to ensure that all ex-
haust systems are turned on
and operating. Then ster-
ilizer door is opened 12
Inches and a minimum wait
period of 5 minutes is util-
ized before the door is fully
opened to unload the treated
materials.
Operators wear respirators
when unloading chambers (and
changing gas cylinders).
Treated loads are immediately
placed in aeration room-
Worker training includes com-
plete training for compliance
to good manufacturing
processes and safety,
training films, on the job
training, and safety films.
Equipment inspection and
maintenance includes checks
of respirator before each
use, of recirculation pump
every 6 months, of vacuum
pump every 6 months, of door
gasket on opening chamber
door, and of humidity sensor!
every 3 months and replaced
every 6 months (4 sensors
rotated for use); and change
oi bacterial air filter every
6 months and of gas filters
every 2 nonths*
Environmental mon-
itoring data is
collected using Miran
103 Vapor Analyzer
(Miran 1A Analyzer is
on order for addi-
tional monitoring).
In response to data
obtained from past
monitoring, exhaust
and ventilation have
been Improved for
sterilization chanber
and aeration room.
With additional
ventilation capacity
and procedural
changes, monitoring
has indicated a re-
duced level of
exposure to ETO.
540
121 ETO
88Z Freon
Vacuum/rear
water system
to outside
cooling
tovar.
Bear 10"
¦echanical
exhaust vent
to outside
atmosphere.
-------
TABLE C-2 (CONTINUED)
n
i
ON
Sterilization/Fumigation Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
SterLlanc
l)«*d
Gas Removal
Sy steai
Total
Number of
Operators8-1
Potential
Exposure Situations'5
Equipment
Design
Workplace
Design*5'0
Work
Pract ice^
Monitoring of
Workplace for Residual
Levels of ETO^
Site C
696
121 ETO
882 Freon®
Water sealed
vacuum pump
exhaust through
water separa-
tor, vented to
sewer.
3
(responsible
for complete
sterilizer
operations,
including
loading,
operation
and moni-
tor ing of
cycle, and
uiloading
treated
material
from
chamber).
Operators must enter
cliamber to retrieve
treated materials.
Multiple post-vacu-
ums (2 are being
drawn at present).
Jacketed chamber
with recirculating
blower system.
Water effluent to
sewer drain lo-
cated next to
chamber.
Vapor exhaust
to outside
atmosphere.
Rectangular hori-
zontal sliding
chamber door is
gasket-sealed.
Sterilization
conducted in 1088
ft2 area located
within restricted
warehouse aer-
ation area.
Ventilated hy use
of 2000 cfmd
mechanical ex-
haust system.
Rate of air ex-
change in ster-
ilizer area is
4.6 air changes
per hour.
Direction of air
flow is from ETO
to non-ETO area.
Warehouse-type
aeration area is
ventilated by
mechanical and
passive airflow
exhausted to
atmosphere.
Access to ETO work area is
restricted to authorized per-
sonnel.
At end of cycle, front and
rear sterilizer doors are
opened and exhaust fan is
activated for 20 minutes
prior to removal of material.
Forklifts are utilized to
place pallets on racks for
10-day aeration period.
Operators provided with
Wilson air-line respirators
and gloves.
Circulated periodicals and
scripts pertaining to safe
handling of ETO and ster-
ilization techniques are
routed to and read by all
operators. Formalized ETO
training procedure is being
implemented.
Procedures are followed prior
to each cycle which include
inspection of critical areas
Preventive maintenance sched-
ules are enforced and
recorded-
Monitoring is in
progress at present
(August 1980) using
charcoal tube analysis
by gas chromatography,
Draeger gas detector
tubes, and 1ST 6ensor.
Site reports that
although data are not
available at present,
ventilation is being
improved and training
increased.
-------
TABLE C-2 (CONTINUED)
n
I
Facility
Steril Izatlon/Fualgatioti Equipment
Total
Number of
Operators^**
Control Measures Implemented
Monitoring
-------
TABLE C-2 (CONTINUED)
1'ac i1i t y
S'.erilizatIon/Fumigation Equipment
Tot* 1
Nuaber of
Operators®^
Potential
Exposure Situations**
Control Measures Implemented
Sizf of
Sterilizer
0
]2Z ETO
8B2 Freoi^
Vented via pipe
lo outside
atmosphere.
1-4
Workers oay have to
enter sterili2er when
treated product ex-
pands and cannot be
removed through nor-
mal procedures.
Sterilization and
ventilation areas are
not restricted, but
only personnel asso-
ciated with sterili-
zation are in that
area.
One post-vacuum.
Each sterilizer
equipped with
gasket seal.
For first 750 ft3
sterilizer, treat
ment conducted in
warehouse (200* x
100' x 18'), for
(2) 140, 250, and
J000 ft* steri-
lizers in ware-
house (460' x
10V x 17'); and
for other 730 ft3
sterilizer In
(140' x 84* x
13') general
work area.
All 3 ETO work
areas have me-
chanical area
ventilation and
the direction of
airflow is from
ETO work area to
non-ETO work
area.
Room vents ex-
haust to out-
aide atmosphere.
\t end of cvcle, iharaber is
allowed to aerate /or mini-
mum of 15 minutes before
removal of treated material.
Treated material is skidded
and transferre'd frv hand
pallet truck.
Workers receive on-the-job
training.
Sterilization equioment
periodically checked b\ ln-
house personnel (and manu-
facturers if required).
Moni t - r i i »>nductiM
bv out i J< < otisul-
tar, f . (,sc i 1 11 v
revit-wln^ in-lmusc
c*-M ir.y. .
Monitoring datd not
avallable.
(J) UU
iouo
122 ETO
882 Freotr*
Vented via pipe
to out.slde
atmosphere•
7b0
122 ETO
882 rreon'S'
Vented via pipe
to outside
atmosphere.
-------
TABLE C-2 (C0N1INUED)
Srer1liiation/Fumigation Equipment
Facllity
Size of
Sterilizer
c
Work
PractIces*5
Monitoring of
Workplace for Residual
Levels of ETO^
12Z ETC
88Z FreorP
Exhausted to
enclosed sewer
drain and ex-
haust fan and
stack.
Exhausted to
enclosed sever
drain.
1-4
(Operators
required Co
stage pro-
duct, com-
plete doc-
umentation ,
check con-
dition of
sterilizer,
and verify
that all
adjustable
mechanisms
are set to
sped fled
parameters,
Access to ETO steri-
lization area in not
restricted to the 1-4
operators. An ad-
ditional 5-8 employees
(Including micro-
biologists, main-
tenance mechanics,
supervisors, quality
control inspectors,
and engineers) may
come into indirect.
Inconsistent, or
peripheral contact.
Operators must enter
steriliser for short
period of time to
manually unload
treated lots.
Chamber manufac-
tured by Beverly
Pacific.
Two post-vacuums.
Chamber door
equipped with
interlocks and Is
hydraulically
tightened.
Chamber equipped
with le«ib alarm.
Chamber manufac-
tured by Vacudyne
Altalr.
One post-vacuum.
Door equipped with
leak alarm*.
Door equipped with
leak alarm*.
Sterilization
conducted in new
warehouse facil-
ity which has
central fan sys-
tem, a rate of
air exchange of
20 air changes
per hour, and
direction of air
flow la vertical-
Guard fence
around Vacudyne
chamber, primar-
ily for equip-
ment protection.
Aeration areas
(designated as
sterilized
product-only
area) located
near sterilizer.
At end of Beverly Pacific
1000 ft3 chamber cycle, doors
are automatically cracked
(following double-vacuum
alrvash) and double recir-
ulatlng blowers are acti-
vated for 1 hour before
ated materials are removed
froa chamber.
At end of Vacudyne Altalr
430 ft* chamber cycle, dooru
are manually cracked 6-8
Inches (following air wash)
for mlnlmm of 20 minutes
before treated materials are
removed .
Treated materials are trans-
ported on pallets by battery
operated fork truck and hand
trucks.
Operators are required co
wear protective goggles while
hanging 12/88 cylinders.
Operators receive personal
lnatruction from supervisors
only, including written mate-
rials on function and theory,
component systems, drawings,
safetv, copy of nrocedures,
required documentation, and
written aad oral testing.
There is specific
Standard Operating
Procedure which ad-
dresses Vapor Envi-
ronmental Monitoring
for each sterilizer
located in Its
respective sterl-
1izatlon area.
Wilks-Mlran 101 -CT0
Vapor Analyser was
used for analysis.
All readings accumu-
lated since monitoring
began have fallen
under maximum allowable
OSHA limits set for
ETO vapors.
Changes have been made
by Installing venti-
lation system and
imp 1even ting training
program for proper
procedural handling
and associated work
practices for dealing
with use of ETO gas
for sterilization of
product.
Subsequent ETO vapor
analysis after imple-
mentation of changes
mentioned above-
-------
TABLE C-2 (CONTINUED)
0
1
00
o
Sterilization/Fuaigatioo Equipment
Total
Number of
Operators*^
Potential
Exposure Situations^
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETc£
Facility
Size of
Sterilizer
-------
TABLE C-2 (CONTINUED)
Sterilization/Fumigation Equipment
Control Measurea Implemented
Facility
Sire of
Sterilizer
(ft3)
Sterilant
Vted
Gas Removal
Syttea
Total
Number of
Operators^!
Potential
Exposure Situations
Equipment
Design
Workplace
Designee
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETC*5
Site K
528
634
1280
121 ETO
882 Freod®
Vented to
storm sewer
and outside
atmosphere.
3
Operators must enter
chamber to retrieve
Created materials.
Multiple post-
vacuums to storm
sewer plus water
separator for ex-
hausting into
atmosphere at
height of approxi-
mately 45 feet
above ground
level.
Sterilizers
equipped with
vacuum puaro which
draws ambient air
into chamber to
vent/dilute
sterilant gas
still in chamber.
Upon opening of
door, 2200 cfmd
exhaust blower
(which is con-
nected to grate-
covered pit in
front of steri-
lizer) exhausts
sterilant gas
which nay be
emitted from the
chamber.
Lxhaust outlets
ere above and awaj
from any factory/
office air intake
source.
Sterilization
conducted in
warehouse (200' x
200' x 37').
Warehouse fitted
with 3 turbine
roof ventilation
fans 200 cfm^
each which cap
vent stacks on
roof of ware-
house and with 4
ceiling fans (1)
9000 cf».d (2)
26,500 ct»,d (1)
18,000 c£**d
Bate of air ex-
change is 10 air
changes per
hour.
Direction of
airflow is
towards ETO work
area and away
from non-ETO
areas.
Sterilization area is re-
stricted to ETO workers and
maintenance personnel.
At end of cycle operator
opens door 6 inches.
Operator presses cycle start
button which starts vacuum
pump (see equipment design).
At the end of these actions,
operator leaves ETO area for
10 minutes. At the end of
this time period the oper-
ator returns, opens the
door completely, and again
leaves Che area for 10
minutes.
In moving material from
chamber to sterility-hold
area, operator operates fork
lift from front end so that
any remaining gas in product
will trail behind operator.
Workers provided with com-
pany-purchased clothing.
Meetings are held periodi-
cally for experienced worker!
by Production General Fore-
man to discuss both old and
new procedures. New workers
are indoctrinated and
trained by experienced op-
erators. As new procedures
Samples of ETO vapors
have been collected by
drawing ambient area
air through Qazi and
Ketchum tubes. Char-
coal tubes of system
were attached to em-
ployee near breathing
zone. Pumps were
calibrated prior to
any tests us'tag bub-
ble meters C*0.01 L/
Mlo.) Samples col-
lected were analyzed
at A.I.K.A. accredited
lab (National Loss
Control Service Corp.)
using NI0SH procedure
S286. Additional
data was not reported.
-------
TABLE C-2 (CONTINUED)
Facility
S'erillraCion/Fumigation Equipment
Total
Nuaber of
Operators3"'5
Potential
Exposure Situation^
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOb
Size of
Sterilizer
(it3)
Sterilanc
I'sed
das Removal
System
Equipment
Design
Workplace
Design^'0
Work
Practiced
Sid- K
(Concluded)
Treated materials
are on wooden
pallets which
roll on ball-
bearing rollers,
making them easily
movable. Ease of
movement allows
for minimum workei
exposure to resi-
dual gas.
During removal of
treated materials,
vacuum pump is
operating and
continues to ex-
haust gas from
bottom of
chamber.
Chamber door cart
not be accidently
closed because
"self-operating"
stop prevents
door closure.
Also available
to operator in-
side chamber are
pull cords to
shut off all pow-
er, to open vent
valves, and to
activate alarms.
and/or good manufacturing
practices are developed, they
are posted on bulletin board
at sterilizer units.
Preventive maintenance (P.M.)
program is established
through use of addressngraph
plate system. Plates are
automatically fed monthly
into sorting system which
designates P.M.'s for any
specific month; plates are
then put into printing unit
which stamps out work order.
On daily basis, plant engi-
neer reviews process chart
of each unit and then
visually inspects controls
and process parameters of
each unit.
-------
TABLE C-2 (CONTINUED)
Facility
S'.er 11 iiat ion/Fumigation Equipment
Total
Number of
0perator*a£
Potential
Exposure Situatlonsb
Control Measures Implemented
Size of
Sterilizer
(ft3)
Sterilant
Used
Cas Reaoval
Systea
Equipment
Des Ign
Workplace
Designee
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETO^
Site L
1500
12 X ETO
881 Freod®
1001 ETO
Vented to out-
side atmosphere
5-8
5
Workers must enter
the chanter to re-
trieve treated
materials.
Materials are aerated
in an open space of
warehouse with no
special ventilation.
Multiple post-
vacuums •
Chamber equipped
with water sealed
vacuus pimp, with
vater recycled
through outdoor
coollag tower.
Sterilizer can be
programed to per-
form up to 5 post-
vacuums •
400 cfmd of air is
purged through the
second and third
sterilisers and
discharged
outdoors•
Chamber sealed
with 6 manual
clamps and rubber
gasket.
Chamber equipped
with roller
conveyors.
One 1500 ft3
sterilizer locata
la a separate rocn
(76' x 11'6" x
22') that has me-
chanical area
ventilation; a
rate or air move-
ment of 1400 cfv^
and in which the
direction of air-
flow is from the
ETO work area to
outside atmosphere.
For second steri-
lizer, treatment
Is conducted la
general work area
(801 x 13' x 18*)
vlth passive area
ventilation.
For third steri-
lizer ETO work
area dimensions
were not reported
however, the area
has mechanical
ventilation, a
rate of air mover-
Kent of 1200 cfm/J
and the direction
of airflow is fran
ETO work area to
the outside
atmosphere.
Additional ven-
tilation will be
added In work ares
and aeration area.
Access is limited to ster-
ilization workers and
material handlers.
At the end of cycle, chamber
door is left open for 15
minutes before treated ma-
terials are removed.
Sterilized items are reooved
by fork lift truck and
transferred to warehouse-
Operators wear face shield
and gloves when handling gas
containers.
Operators receive Instruction
mi the operation of ster-
ilizer, safe handling of
gases, and emergency pro-
cedures .
Regular maintenance is per-
formed, which includes
maintenance of components,
leak testing, and cali-
bration of controls-
Monitoring for en-
vironmental levels of
ETO using gas chrom-
atograph (NIOSH method
S286) has been con-
ducted Inside the
sterilization and the
aeration area.
Monitoring data were
not made available.
1500
121 ETO
88Z Preon®
Vented to out-
side atmosphere
1500
12Z ETO
882 Freon®
Vented to out-
side ataosphere
-------
TABLE C-2 (CONTINUED)
n
i
oo
Sceriliration/Fumigation
Equipment
Control Measures Implemented
Pacility
Size of
Sterilizer
(ft3)
Sterilant
Used
Gas Removal
System
Total
Number of
Operator*^
Potential
Exposure Situations13
Equipment
Design
Workplace
Design^
Work
Practices1*
Monitoring of
Workplace for Residual
Levels of ET0b
Site M
810
12Z ETO
88Z Freon®
Pulsing vacuum
to outside of
building,
1-4
Not available.
Chamber manufac-
tured by Vacudyne
Altair.
ETO work, area is
(6* x 6' 22.5'),
located in large
warehouse equippec
with large ceiling
fans.
Three air wash
cvcles.
Access to sterilization and
quarantine areas restricted
to authorized personnel.
Recently instituted a 15-
minute time delay between
first opening of chamber
door and retrieval of ster-
ilized items.
Treated materials removed
with hydraulic hand truck anc
placed in quarantine area.
Operator pulls hard truck.
Operator wears gas mask and
gloves.
Operator given complete
written instructions for
operation of sterilizer and
receives training and guid-
ance from foreman.
Regularly scheduled program
of equipment inspection and
maintenance. Documentation
of program available at
sterilizer and in Master
Device Record.
Treated material aerated in
quarantine area for 10-14
days, and then may remain
in storage shelves for up
to 3 years.
None
-------
TABLE C-2 (CONTINUED)
0
1
CO
Ln
SeerllItatiou/Fumlgatioa Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
Sterilise
Used
GtJ Reaowal
Systea
Total
Number of
Operators^
PotMtijl
Expoaure Situations'1
Equipment
&esIgo
Workplace
Deilgnb'c
Work
Practices^0
Monitoring of
Workplace for Residual
Levels of ETC?5
Site N
1500
122 ETO
8BX Freon®
1002 ETO
Vented to
atmosphere.
2
Treated aaterlals Te-
Boved from chamber
Immediately at end of
cycle; no time delay
ac end of cycle.
Chamber manufac-
tured by Vacudyne
Altalr.
Two post-vacuums.
Valves allow cham-
ber recirculation
ays ten to purge
chamber.
Gas separated out
of recirculating
water system and
vented to roof.
Microcomputer pro-
grans chamber for
treatment cycle;
sounds buzzers if
problem occurs and
can abort cycle if
necessary.
Chaaber door
opens to ware-
house area;
however, chamber
is isolated by
explosion-proof
door and concrete
block vails (1
ft. thick).
12/83 and 1001
ETO tanks are
segregated from
each other and
from sterilizer.
Fan (A1 x 4') in
celling at end o]
warehouse op-
posite sterilise!
operates
continuously.
Treated materials are stored
in warehouse for 14-15 days.
Operators use propane-powered
forklift to load and unload
chaaber rapidly (taking ap-
proximately 15 minutes).
Operators wear gloves and
face shield when changing
cylinders; safety shower
located In equipment area;
oxygen supplied respirator
available In case of
emergency.
Warehouse doors near steri-
lizer left open while
sterilizer in operation.
Operator received 2 weeks of
training from Vacudyne.
Operator uses bronze wrenches
when changing ETO tanks to
prevent sparks.
Lover explosive limit
sensors (manufactured
by Mine Safety Ap-
pliance Company) in
area around chamber
and in tank storage
area.
Additional data
not available.
-------
TABLE C-2 (CONTINUED)
o
00
&
Sceriltlac ton/Fumigation Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
Sterilant
Used
Gas Reaovai
Systea
Total
Number of
Operator#®*13
Potential
Exposure Situation^
Equipment
Design
Workplace
Design V:
Work
Pract ice^5
Monitoring of
Workplace for Residual
Levels of ETO
Site 0
1023
12X ETO
881 Freon®
Vented to out-
side atmosphere
2
Access to ETO work
area is not restricted
to ETO sterilization
workers.
Sterilizer located
near general walk
way; therefore, other
workers may be ex-
posed to ETO.
Four air washes
performed (each
lasting 15 min-
utes) at end of
exposur* cycle.
Sterilizer manu-
factured by
Vacudyne/A1tair.
Sterilization
conducted in large
warehouse.
rwo large fans rur
continuously at
opposite ends of
warehouse.
At end of cycle, chamber door
is opened for 3 to 4 hours
or* overnight before treated
materials are removed.
Treated materials are placed
in fenced quarantine area
for 14 days.
Operator received training at
previous job experience.
Site has service contract
with private firm, but
follows Vacudyne schedule for
parts replacement. Ster-
ilizer Is checked every 2
weeks for leaks around gas-
kets, piping, and area
around ETO cylinders.
None
-------
TABLE C-2 (COHTINUED)
n
i
00
Srerlliratlon/Fuailgation Equipment
Size of
Steriliser
(ft3)
Sterilant
Used
Cas Removal
Systeas
Total
Number of
Operators*^
Potential
Exposure Situations^
Control Measures Implemented
Equipment
Design
Workplace
DeaigiAc
Work
Practices^
Monitoring of
Workplace for Residual
Levels of ETQb
(2) 675
122 ETO
881 Freon
Vented Co
ataosphere.
Not
avallable.
Sot available.
Chaaber equipped
with pulsing vac-
uum and multiple
air washes, which
are vented to 10
feet above highest
roof elevation; 3
water seal vacuum
cycles; and gasket
seals.
Soof vents located
acre than AO feet
from nearest KVAC
unit-
Sterilization
conducted In
room measuring
60' k 30' x 24'.
Mechanical area
ventilation.
Air movements
controlled by
fan with dual
speeds of 3240
cfmd and 5388
efm.^
Direction of air-
flow is towards
ETO work area
from nor-ETO
work areas.
Access to ETO work area is
restricted to tethered^
personnel.
At end of cycle, operators
enter chamber wearing pro-
tective equipment.
Treated aaterial aerated
in chamber room for mini-
mum of 24 hours.
Protective equipment worn
by operators include 3M
hardcap tether which is de-
signed to provide Crade D
breathing air® (air compres-
sor source, carbon monoxide
monitor, filter, oil filter,
and compressor high temp-
erature shut down) and
gloves.
ETO workers follow written
procedures on sterilization
process.
Preventative maintenance is
performed on all sterilizer
equipment, including air
compressors and breathing
apparatus. Monitoring
equipment is calibrated-
Monitoring Is being
conducted with Uilks
Miran and HNu equip-
ment to determine
aeration efficiency.
Site reports that grab
samples (charcoal) Jnd
TWA measurements have
been performed.
In response to moni-
toring data, ventila-
tion has been in-
creased, surveys have
been conducted of air
and water exhausts,
and personal protec-
tive equipment
tilized.
Sit* reports that ex-
posure has been re-
duced and that further
tests are being con-
ducted to determine
total gain.
-------
TABLE C-2 (CONTINUED)
Steri1Itatlon/Fualgatioo Equipment
Control Measures I
&pl enented
Facility
Size of
Sterilizer
(it5)
Sterllant
I! sad
Systea
Total
Nuaber of
Operator#*^
Potential
Exposure Situational
Equipment
Dealgn
Workplace
Dea lgt£ ,c
Work
Practices6
Moni toring of
Workplace for Reslduil
Levels of ETO6
Site Q
8.8
12Z ETO _
881 Freoo
Vented to
•t*osphere,
1-4
Not available.
Chamber equipped
with dual vacuus
and f11tered air
cycles for evac-
uation of gas.
Aerator vented
to outside
ataoaphere.
ETO work area
aeaaureb 29'8"
x 10'fe" * 8' 10".
Area ventilation
by HVAf unit.
Rate of air ex-
c han ge 1 s 6 a 1 r
changes per
¦inute.
Direction of air-
flow Ik nega 11ve .
Access to ETO work area la
United to 1-4 ETO operators,
Quality Control labeling
technicians artd tticro-lab
per*onne1 •
At *nd of cycle, chuaber door
Is opened 3 inches, the roon
In evacuated and locked for
*> minutes. At the end of
this period the operators
re-enter the rooai, unload
the baskets containing
treated materials and place
thea slde-bv-fcide on a table-
top for 10 alnutes. Lent,
pouches are trsnsferred to
»aall baskets and plated
Into an aeration cabinet.
Workers do not enter either
i»terlll*er or aerator. Hie
roots lb opened and poHt-
sterilization inupe*tIon
con t inut-tt'
Operators wear head rovers,
lab l oaltt, and capt Ivr
shoes.
Each steriliser operator
undergoes thorough training
program based upon HI MA
suggested guidelines nod-
Ifled to fit company's
special aspects. Program
requires approximately 2
weeks of full tlae
involvement. At the end of
Monitoring has been
conducted. Levelh
of ETO were fotaid to
be acceptable-
Add 11 li.nrt 1 data not
avallablr¦
-------
TABLE 0-2 (CONTINUED)
Facility
Sterlll*atlon/Fumigatl«m Equipment
Potential
Exposure Situations*1
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ET0b
Site of
Sterilizer
(ft'>
Stcrllant
Us*d
Gat Reaoval
Syat«a
Total
Nuabcr of
Operatora*J
Equipment
Design
Workplace
Design1^
Work
Practiced
Site Q
(Concluded)
program, a test 16 given to
operator to docuaent his
prof icieftcy.
Regular schedule of equip-
ment inspection and
ulntenanc« including Monthly
mechanlcel/eleccrleal pre-
ventive maintenance checks,
quarterly calibration of all
lnatriAents (In compliance
with CMP), and seal-annual
*>nitorlng for ETO level».
-------
TAM t C-2 (CONTINUED)
SieriliuCloa/FualgaCioQ Equipment
Total
Nuaber of
Operators**
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETC^
Facility
Size of
Sterillter
(ft3)
Sterilant
Used
Gas Removal
Systea
Potential
Exposure Situations^
Equipment
Design
Workplace
Design**0
Work
Pract ices'5
Site R
3(900)
1000
12X ETO A
88Z Freoo
All charters
vented co out-
side atmosphere
9
Access to ETO work
area Is not restricted
to ETO operators.
(4) Continuous
purge systea.
(4) Compressed
air flush.
(1) High voliae
blower flush.
The ETO work
area for each
set of steri-
lizers is located
in a general work
area that is part
of a warehouse.
Is each warehouse
there is
¦echanical area
ventilation.
The volume and
rate of air
movement for
each warehouse
for each set of
sterilizers (as
represented by
groupings Id
column 2) are
1.23 million ft3
(160* x 256' *
30') and 20,000
cfad (provided by
6 units), 2.4
million ft3 and
8700 cfad (pro-
vided by 8 units
units), and 0.23
ailllon ft3 and
4300 cfm^ (pro-
vided by 2 units),
respectively.
ETO operators fully respon-
sible for ETO sterilization
work which Includes moving
materials in and out of area,
loading and unloading ster-
ilizers, and monitoring cy-
cles as they progress.
At end of cycle, chamber
door is opened approximately
6 Inches. Then there is
a 1 hour tlM delay before
operator can enter chamber-
Worker uses electric fork-
lift truck to remove treated
materials from chamber.
Operators are required to
wear goggles and charcoal-
filtered masks when unloading
sterilizers and to wear
gloves (in addition to gog-
gles and masks) when
changing gas cylinders*
Workers are trained by
operations personnel ac-
cording to existing proto-
cols as Co their
responsibilities•
Yearly maintenance schedule
is set up for all hardware,
pisips, blowers and filters
and quarterly calibration
Inspection done to controls.
Monitoring was per-
formed using Centurv
Systems Corporation
model OVA-118.
Additional data not
available.
900
900
1150
12Z ETO
86Z Preori®
(2) Continuous
purge systea.
(1) Compressed
air flush.
(1) High voliae
blower flush.
(1) Continuous
purge system-
10Z ETO
90Z C02
121 ETO
88Z Freoa®
-------
TABLE C-2 (COHTIWJED)
0
1
vO
FaciliCy
Sterilized
on/Fumigation Equipment
Total
Number of
Operator*®'*1
Potential
Exposure Situation**1
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO5
Site of
Sterilizer
(ft3)
Sterilant
I1* ed
Gas Removal
Systex
Equipment
Deaiga
Workplace
D««Igo^
Work
Practiced
Site Sh
Location 1
121 ETO
881 Freori®
In all
sterilizers
>16
Hot available.
Mechanical area
ventilation in
all ETO work
area.
Access to sterilization and
aeration areas limited to
authorized personnel.
At completion of the ster-
ilization cycle, sterilizers
equipped with vacuum capa-
bilities draw an additional
vacuum. The door is then
opened approximately one
inch and air Is drawn into
sterilizer by the vacuum
pump system. Local exhaust
ventilation is used at the
lower edge of the sterilizer
door on the open side. Doori
remain in this position for
30 minutes before product
is renoved. For larger pal-
letized product, sterilizers
equipped with rear vent ex-
haust through the ster-
ilizer for 30 minutes before
the door is fully opened and
the product is removed. Ex-
haust through the rear vent
remains on throughout the
unloading process.
For sterilizers equipped
with rear vent exhaust
systems (to draw air
through the sterilizer away
from the operator) pallets
are removed using a
General air samples
and personnel samples
have been monitorc-d
at all 4 locations
using the Qazi-
Ketcham charcoal tube
method and Wilks-
Mlran-101 instruments.
In response to data
obtained from such
monitoring, various
changes have been
made with both the
equipment and proce-
dures which have re-
duced ETO levels both
in the sterilizer
areas and in the
general work area.
Changes in equipment
include longer aera-
tion following ster-
ilization cycles and
installation of rear
vent exhaust systems
to exhaust sterilizer;
directly to the at-
mosphere during the
unloading. Hoods
have been installed
over sterilizer doors
where this type of
installation provided
adequate control of
ETO emissions. Iso-
lated areas for
1.68
2615
2345
Vented to
atmosphere.
Canopy hood lo-
cated above
sterilizer.
Sterilization
conducted in
work area (76'6"
x 29' x 9'6") ;
10 air changes
per hour.
Both vented to
atmosphere.
Rupture disc in
ETO supply line
venting to ex-
haust duct If
pressure problem
appears; chamber
doors are vell-
gasketed.
Sterilization
conducted in
40' x 27' x 12 *
work room.
Normal exchange
with ceiling
diffvsers. 8-
hour exhaust
through chambers
when venting.
24
Vented to
ataosphere.
Vented to
sewer drain.
Ifeiitlple air
flushes at end of
sterilization
cycle.
Sterilization
conducted In
24' x 11' x 12'
room.
144
Sterilizer is
double ended and
opens into two
rooms; water-
sealed vacuum
pump evacuates
Sterilization
rooms are
32' x 16* x 12'
and 40* x 25* x
12*.
-------
tartr C-2 (CONTINUED)
0
1
vo
NJ
Sterilizatlon/Fwlgatioo Equipment
Control Measures Implemented
Pacillty
Size of
Sterilizer
(ft3)
Sterilant
Uied
Gas Removal
Systea
Total
Nuabei of
Operators*1*
Potential
Exposure 51tuationsb
Equipment
Design
Horfcplace
DealgnNc
Work
Practices^
Monitoring of
Workplace for Residual
Levels of ET(£
Site Sh
Location 1
(Continued)
chamber 3 tiaes at
end of cycle;
canopy hood lo-
cated over each
door.
hand-operated pallet truck.
Entry into sterilizers not
equipped with a rear vent
system is not permitted. The
pallets are pulled on rollers
to the sterilizer door and
then removed by either a
fork lift truck or a hand-
operated palle: truck. To
enter these sterilizers
(either to remove pallets or
spilled material) sterilizer
operators must wear either
air-supplied respiratory
protection or self-contained
breathing protection.
Freshly sterilized products
are removed to isolated
areas, such as warehouse
or storage space, where they
aerate for at j.east 24 hours.
Personnel are not permitted
aeration of product
following sterili-
zation have also been
set up where neces-
sary. Work procedures
and practices have
been modified to re-
duce exposures to the
lowest possible level.
Personnel exposed to
ETO are trained in
these procedures and
in emergency proce-
dures. Procedures
and practices are mod-
ified when industrial
hygiene Information
indicates ETO expo-
sures are higher than
desirable.
Industrial hygiene
surveys are per-
formed periodically
98
148.5
Both vented to
ataosphere.
Both sterilizers
manufactured by
AMSCO. Large
charter is double-
ended.
Sterilization
rooas aeasure
20* x 13'6" x 10*
for saall chamber
and 22* % 14' z
9* and 33' x 8'6"
* 9' for large
chamber.
ETC cylinders and
controls located
in separate ma-
chine room
(which has an ETO
alarm). Exhaust
fan located above
cylinders.
209
Vented to
atBosphere.
Vacuia puap to
drain.
Sterilization
room Measures
65' x 18' x 10';
20 air changes
per hour; ETO
tanks located
in separate room.
in these areas during this
period—except for placement
of freshly sterilized product
or reaoval of finished pro-
duct. Exhaust fans in the
celling and in the side wallt
are used to reuove ETO vapor*
directly to the outside
atmosphere.
Workers wear protective
gloves, splash-proof cheaica^
goggles, or fun face shield
using both personnel
samples and general
area measurements to
confirm that proce-
dures and equipment
are operating satis-
factorily and to
evaluate changes in
procedures and equip-
ment. Lower 8-hour
Time Weighted Average
readings were obtained
at two different loca-
tions after changes
-------
TABLE C-2 (CONTMJED)
0
1
vO
LO
Steriliiation/Fualgatioo Equipment
Control Measure* Impleaented
Facility
Size of
Sterilizer
(ft3)
Sterilant
Used
Gil ReaOVll
Systea
Total
Nuabec of
Operators3**
Potential
Exposure Situational
Equipment
Design
Workplace
De«ignb,c
Work
Practices^
Monitoring of
Workplace for Residual
Levels of ET0b
Site Sh
(Continued)
Location 2
65
Vented to
atsesphere (gas,
and to drain
(condensate).
Double-ended;
Liquid/gas sep-
arator; Multiple
post-vacuuas.
Preparation Rooa
(load side of
sterilizer) is
42' x 12' x 9'
with air aove-
aent rate of
2500 cfm; air
exhausted througt
ceiling vents
directly above
sterilizer doors
Corridor at dis-
charge side of
sterilizer is
36' x 8' x 9'
with air aove-
aent rate of
1600 cfn;d air
exhausted at
floor level.
during hook-up and break-
down of ETO lines to cylin-
ders and storage tanks.
Respirators are required
whenever entry into a ster-
ilizer containing ETO is
required or during an eaer-
gency if a leak should occur.
Personnel working with
ethylene oxide sterilization
processing are trained in
the hazards of ETO and ETO/
freotil® mixtures, the syaptoms
that nay occur froa an expo-
sure or overexposure; nonaal
operating procedures for the
sterilizers which they oper-
ate, procedures which reduce
the potential for exposure
to ETO to a minimum, and
training in emergency
procedures.
Inspection and maintenance
requlreaents vary at this
flrn's four locations. Con-
tract maintenance and inspec*
tion services are utilized
at sone locations, while at
larger locations in-house
maintenance personnel per-
form periodic inspections of
the sterilizers and the op-
erating equipment.
(unspecified) were
aade in operating
procedures and
equipment.*
Gas Tech monitor model
1565, with 4 pick-up
points (load side, un-
load side, sterilizer
service area, and ETO
tank manifold), dual
alarm levels (20 ppa
and 50 ppa), and
audio-visual alarms
are to be Installed
in area around 65 ft^
sterilizer.
Location 3
(6)1000
Vented to
drain.
Sterilisation
rooa is 104' x
31' x 20'.
Bear exhaust
vent and low
level vent at
bottoa front
corner of one
chaaber, and low
level vent at
bottoa front of
another chaaber.
Both added by
facility.
-------
TABLE C-2 (CONTINUED)
n
i
\o
Ster i 1 izacton/Fuatgacioa Equlpaenc
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
Sterilant
Used
Gas Removal
Systea
'Total
Nuaber of
Operators'^*
Potential
Exposure Situations^
Equipment
Design
Workplace
Desigtr ,c
Work
Practices**
Monitoring of
Workplace for Residual
Levels of ETOb
Site Sh
(Continued)
Locatloo 4
(4)858
(4)1000
Vented to
atmosphere.
«) 858 ft3 ster-
illzers located
in 2 toons (25* *
29' x 2i' each).
(4) 1000 ft3
sterilizers lo-
cated in 58' x 99
x 115' rooa.
Exhaust ventila-
tion fan and dust
in top of 1000
ft3 sterilizer
rated 1800 cf.-d
Mechanical area
ventilation of
ET0 cylinder man-
ifold rooa.
-------
TABLE C-2 (COHTDfUED)
0
1
>sO
Ln
Sterilization/Fumigation Equipment
Control Measures lAplesented
Facility
Sire of
Steriliser
(fts)
Sterilant
Used
Gas Removal
System
Total
Nuaber of
Operators^
Potential
Exposure Situational
EquLpaent
Design
Workplace
De«igi^-C
Work
Practices^
Monitoring of
Workplace for Residual
Levels of ETO
Site T
1953
12Z ETO
881 Freoi.®
Vented to roof-
top vent to
ataosphere.
1-4
Access to ETO steri-
lization area is not
limited to ETO steri-
lizer operators;
sterilizer and test
area located adjacent
Co access way used by
other personnel.
Operators Bust enter
chamber to unload
treated Materials.
Operators must open
cases containing
treated materials to
remove biological
indicators and then
reseal case almost
immediately after
treated materials
are removed froa the
chaaber.
No less than 2
vacuum/air ex-
changes at end of
cycle.
Chaaber equipped
with liquid ring
vacuus ptn^3 for
evacuation.
Service water
puaped to open
floor drain.
Sterilization
conducted in
open, L-shaped
warehouse that
¦easures 10,000'
on long leg and
5,000* on short
leg, with steri-
lizer located
at their juncture
(total warehouse
measures approxi-
mately 90,000
ft2).
Passive area
ventilation.
Facility reports
rate of air ex-
change is nominal
and that there is
free movement of
air.
At end of cycle, operator
opens door, then leaves area
for not less than 5 minutes.
Upon return, he nonitors ETO
concentration at open door-
way with Wilks-Hiran 101
specific vapor analyzer to
determine if ETO concentra-
tion is no more than 50 ppm
(typical values range fron
10 to 40 ppm).
Operator then enters chamber
to nove pallets to doorway,
which are then retrieved by
forklift and transferred to
open "on-test" area 20* fron
sterilizer.
Operators receive supervisory
instruction and detailed
written procedures.
Sterilizer is inspected and
lubricated weekly and
monthly; overhaul of puaps
and fans performed quarterly
and seal-annually.
Refer to Work Prac-
tices co 1 umn .
-------
TABLE C-2 (CONTINUED)
0
1
vO
Sterilisation/Fumigation Equipment
Control Measures Implemented
Facility
Site of
Steriliser
(ft3)
Sterilant
Used
Gm Removal
Syttea
Total
Huaber of
Operators4^
Potential
Exposure Situation#15
EquIpment
Design
Workplace
Des Igif,c
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETO
Site U
1700
12Z ETO
881 Freon®
Gas exhausted
by pulsing
vacuum to
outside
ataosphere.
5-8
Access to steriliser
and quarantine area
is not restricted to
sterilizer operators.
Operators aust enter
chamber to imload
treated materials.
CKaaber equipped
trlth two air
washed.
Sterilization
conducted in
general work area
measuring
1,500,000 ft3.
Mechanical area
ventilation (fans]
with air exchange
ranging froa 0 to
24,000 cftrf1 de-
pending on out-
side environment.
Quarantine area
¦easures 840 ft2
(within 100,000
ft2 warehouse).
Door seals are loosened
during second air wash vacu-
us. As second air in-bleed
occurs, operator opens both
chaober doors. There is
usually a 5 minute delay be-
tween the opening of the
sterilizer door and retrieval
of the treated materials.
Operators transfer individual
pallets (containing ET0-
treated material) with fork-
lift from chamber to
quarantine area for approxi—
macely 14 days.
Operators trained in steri-
lization procedures, safety,
and ETO handling.
Preventative maintenance is
performed on major equipment,
such as puaps. Vessel and
monitoring equipment are
calibrated monthly.
Monitoring is per-
formed using gas
chromatograph. Ad-
ditional data were
not reported.
-------
TABLE C-2 (CONTINUED)
o
vo
SteriliiatloQ/Fumigatloo Equipment
Control Measures Implemented
Facility
Sire of
Sterilizer
(ft3)
Sterilant
Used
Cat Reaoval
System
total
Number of
Operators*1*
Potential
Exposure Situational
Equipment
Dea ign
Workplace
Desigi£»c
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETO
Sice V
384
12Z ETO
88Z Freon®
Vented to
atmosphere.
1-4
None
Chamber equipped
with two air
washes and two
post-vacuums.
Chamber equipped
with exhaust
system that oper-
ates while cham-
ber door open is
after completion
of sterilization
cycle.
Sterilization
conducted in
Hospital Dis-
posables Manu-
facturing Area,
which measures
30' x 16' x 10'.
Two ventilation
systems used:
(1) heating/
ventilating roof-
mounted air
handler which
provides a rate
of air exchange
of 34.25 air
changes per hour
and (2) slotted
pick—up at bot-
tom of door and
at floor drain
ventilation
(grille) which
provides a rata
of air exchange
of 1400 cfo.d
The direction of
air flow is down
from the ceiling
to the floor with
both systems.
Access to ETO sterilization
area is restricted to au-
thorized personnel.
Following air washes and
vacuums at end of cycle,
steriliser door is opened
approximately 16 hours be-
fore treated materials are
retrieved.
Operator transfers treated
product with hand-lift from
sterilizer to quarantine are*
In warehouse.
Operator wears protective
clothing (chalcal goggles,
respirator, full face shield,
gloves, and protective suit)
when changing ETO tanks or
when monitoring systen in-
dicates a gas leak in the
sterilizer area.
Operator training in ETO
procedures includes facil-
ity's written standard
operating procedures and on-
the-job training.
Maintenance department in-
spects each section of the
sterilizer on a periodic
basis.
Tank storage area and
sterilizer room are
continuously Moni-
tored with Miran-101-
ETO Vapor Analyzer,
(2) Eamet ETO Gas
Monitors, and Foxboro
Gas Chrooatograph.
On March 24, 1980,
North Carolina De-
partment of Human
Resources, Occupa-
tional Health Branch,
conducted ETO survey
of sterilizer area
and of employees in-
volved with steri-
lization. Survey in-
dicated that there
was no hazardous ex-
posure to operators
while unloading steri-
lizer. No de-
tectable aaounts of
ETO were found in
samples taken and
only "trace" aaounts
of Freon-12 were
found during venting
and vacuum portions
of sterilization
cycle.
On July 17, 1980,
four employees that
were directly and
Indirectlv in contact
-------
TABLE C-Z (GOKTUKIED)
S ter i lint lon/Fu»lg«t ion
Equipment
Control Measures Implemented
Facility
Size of
Steriliser
(ft3)
Sterilant
Used
Gas Reaoval
Systea
Total
Nuabcr of
Operator*3^
Potential
Exposure Situation^
Equipment
Design
Workplace
Deaigii>»c
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETQb
Site V
(Continued)
with the sterilizer
area were tested for
chromosomal abnor-
malities. Result?
were well within
"normal limits".
Facility reports that
these tests will form
a baseline for moni-
toring its anployees
with potential ex-
posure to ethylene
oxide.
In response to data
obtained from moni-
toring, the following
changes were made:
the sterilizer oper-
ator's desk was re-
moved froo the
sterilizer rocm to
decrease significantly
exposed time to the
sterilizer; exit
areas and evacuation
routes have been es-
tablished in case of
an emergency; a
"closet-like" area was
built for the tanks
in use; new gas lines
have been installed;
gas vendors were
changed for higher
quality of gas and
cylinders used in the
tanks; and checks of
-------
TABLE C-2 (CONTINUED)
n
I
vO
v£>
S*erlliutlon/Fimlgatioa EqxtpaienC
Control Measurea Implemented
Facl1i ty
Size nf
Sterilizer
(ft3)
Sccrilsac
Used
Gas Resoval
Systesi
Total
Number of
Operators^®*
Potential
Exposure Situations*1
Equipment
Design
Workplace
Deslgnb*c
Work
Practices'3
Monitoring of
Workplace for Residual
levels of tT(P
S1C« V
(ConcludedJ
the entire sterilizer
operation are being
conducted by the
maintenance department
or a periodic basis
for gas leaks.
-------
TABLE C-2 (CONTINUED)
0
1
h-1
O
o
Sterilization/Fumigation Equipment
Control Measures Implemented
Facility
Site of
Sterilizer
(ft3)
Sterilant
U led
Gas Removal
Systea
Total
Nuaber of
Operator^1
Potential
Exposure Situational)
Equipment
Design
Workplace
Designee
Work
Practices^
Monitoring of
Workplace for Residual
Levels of ETO h
Site V
86
121 ETO _
882 Freon®
Vented to
outside
atmosphere.
1-4
Access to ETO steri-
lization area is
not restricted; how-
ever , warning signs
are posted In steri-
lization area (Fa-
cility reports that
area is soon to be
separated froa other
work areas Co rein-
force access
restrictions.)
Treated materials
are transferred man-
ually fron sterilizer
area to staging area.
Treated aaterial is
not formally aerated.
Sterilizer manu-
factured by AMSCO.
Chamber equipped
to drav three air
purges.
Chamber equipped
with diaphragm
locking mechanism
which locks door
when chamber is in
operation.
Sterilization
area is open to
other areas from
the top (no
ceiling), is lo-
cated in a cannot
area with
shipping and
receiving depart-
ments, and
measures 40* x
16'.
Mechanical area
ventilation
(ducting) with
one air change
every 72 minutes
(approximately).
Direction of air-
flow is positive
(from sterilizer
area to outside).
At the end of the cycle* the
operator opens the steri-
lizer door 6 inches, then
leaves the area for at least
15 minutes before removing
treated material frcm the
chamber.
Treated material is pulled
out of sterilizer on a
"rollout" cart; therefore
operator does not have to
alter chamber.
Operators wear lab cost and
latex gloves when changing
ETO tanks and when proces-
sing material (either before
or after decontamination).
Operators receive on-the-job
training.
Facility contracts with
AMSCO for bimonthly pre-
ventive maintenance. This
includes cycling of machine,
checking valves, changing
filters, inspecting door
seals, and other measures.
Monitoring of en-
vironmental levels
has been performed
using Wilks-Miran 1-A
infrared spectro-
photometer, gas
chromatography, and
Draeger indicator
tubes. Additional
data were not
reported.
-------
TABLE C-2 (COHTDIUED)
n
i
Sterlliratlon/Fumigstioo Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft3)
Scerllsnt
D»ed
Gas Removal
Syste*
Total
Nuaber of
Operators®'^
Potential
Exposure Situation^*
Equipment
Design
Workplace
Design1^
Uork
Practices^5
Monitoring of
Workplace for Residual
Levels of ETO^
Site X
770
880
(3)1650
IOOZ ETO
Vented to at-
mosphere and to
sewer.
9-12
Operators oust enter
chamber Co unload
treated materials.
Tvo post-vacums.
Sterilisation
conducted In
separate roan
which measures
3,026 ft2.
Mechanical area
ventilation with
4 air changes
per hour.
Direction of
airflow is
towards ETO work
area fron non-
ETO areas.
Half of the
aeration area Is
vented to the
outside atmos-
phere, while in
the other half
the air is
recirculated.
Access to ETO work area is
United to authorized
personnel.
10 minutes before end of
sterilization cycle door
hinges are loosened.
At end of cycle, chamber
door opened for 15 minutes
before treated materials are
renoved from the chamber.
Treated materials are removed
frca chanber with a forklift.
High residual products moved
to aeration room and low
residual products moved to
warehouse quarantine racks.
Facility reports that oper-
ators receive "regular"
testing and schooling in
ETO sterilization procedures.
Preventive maintenance coo-
ducted daily and documented.
Hourly investigations and
documentation of process
control equipment. Corporate
calibration program provided
on scheduled basis for pro-
cess control equipment.
None (as of 8/80).
Facility intends to
purchase Wllks-Miran
101 for routine moni-
toring (by 9/80).
-------
TABLE C-2 (CONTIMDED)
0
1
o
N5
Sterilization/Fumigation Equipment
Control Measures Implemented
Faci1ity
Size of
Sterilizer
(ft3)
Sterilaat
Used
Gas Removal
System
Total
Nuaber of
Operator^*
Potential
Exposure Situations*1
Equipment
Design
Uorkplace
Detlgn^»c
Work
Practices15
Monitoring of
Workplace for Residual
Levels of ETO^
Site Y
567
1200
1700
121 ETO
88Z Freot.®
Vented to
atmosphere.
5-8
Nooe
Three air washes
are performed.
Sterilization
conducted in
building (84' *
56r x 20') ventec
by roof blower
and side fan.
Direction of air
flow is towards
the ceiling and
from the side.
Warehouse used
for aeration is
vented at its
celling with (10)
18" diameter
natural draft
ventilators.
Floor area is
vented by power
fan which sup-
plies air at a
rate of 6,000
cfm. Two suppl)
fans within
swamp coolers is
celling area
(together) supply
air at a rate of
4,000 cfa.d
Access to ETO sterilization
area is restricted to au-
thorized personnel.
At the end of the third air
wash, sterilizer doors are
opened approximately 6 inches
for 5 «inutes (while floor
level wall exhaust fans
operate). After 5 minutes,
operator returns to open
doors vide; then after an-
other 5 minutes, the treated
materials are removed frost
the chamber.
A pole and hood are used to
pull the skids out of the
sterilizer and a forklift is
used to move the skids to a
warehouse for aeration.
Operators wear goggles when
changing ETO cylinders.
Operator training is con-
ducted by Sterilization Lead
Operator and Sterilization
Supervisor, and evaluated by
Sterilization supervisor.
ETO sterilization equipment
is Inspected weekly. Main-
tenance is performed only
upon equipment malfunction.
Monitoring is con-
ducted periodically
by Corporate Safety
Engineer. Type of
equipment used and
results obtained were
not reported; however,
in response to data
obtained from moni-
toring one change has
been made in oper-
ating procedures (a
time delay of 15 min-
utes between opening
of chamber door and
unloading of treated
materials).
-------
TABLE C-2 (CONTINUED)
n
i
»—•
o
OJ
Facility
Seerillzation/Fualgation Equipment
Total
Number of
Operators*
Potential
Exposure Situations'3
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOh
Size of
Scerilizer
(ft3)
Sterilant
Used
Gas Removal
Systea
Equipment
Design^
Workplace
De»ignc
Work
Pract ices'3
Sice Z
121 ETO
881 Freon®
In all
sterilizers
Chambers are
equipped with door
Interlocks (6),
local exhaust ven-
tilation (6), one
post-vacuum (4),
30 minute air wash
after conpletion
of cycle (4), and
automatic door
opening (1).
In addition, ETO
tank storage areas
vented (6), check
valves in ETO gas
lines (5), and
air displacement
bleed outside (2).
Aeration chambers
vented to outside
ataosphere.
Mechanical area
ventilation in
all ETO work
areas.
Access to all ETO work areas
is restricted to authorized
personnel.
At completion of the steri-
lization cycle, the steri-
lizer door is opened for 10-
13 minutes before treated
materials are unloaded (4);
the sterilizer door is
opened and the operator
leaves the sterilizer room
for a minimus of 15 minutes;
the sterilizer door is
opened automatically and the
operator leaves the steri-
lizer room for a minimum of
15 minutes (1).
Operators do not enter cham-
ber to remove treated
materials.
Operators wear gloves while
transferring treated mate-
rials from sterilizer to
aerator; respirators are
available to operators at
three ETO work areas in the
event of major spills or
leaks; and a face shield is
worn when changing ETO tanks
In two ETO work areas.
All sterilizer operators are
required to attend operator
certification classes.
There is a regularly
scheduled program of equip-
ment Inspection and
maintenance.
ETO work areas moni-
tored with Wilks-
Miran 1A gas analyzer.
Levels were found to
exceed 100-200 ppm
when the chamber door
was opened and while
changing tanks (gas
line bleeding).
In response to these
data, local exhaust
vents were installed
over the chamber door,
at the drain, and over
the tanks. Monitoring
performed subsequent
to this installation
detected ETO levels
below 5 ppo (8 hour
time weighted
average). Facility
also reported that
peaks rarely reach
15 ppm.
4.5
Vented to
sewer drain.
1-4
Sterilization
conducted in
separate room
(6' x 10' * 8'),
6.75
Vented to out-
side atmosphere
1-6
Sterilization
conducted Id
general work
area (8' x 15' i
r).
9.3
Vented to
sewer drain.
1-4
Sterilization
conducted
Microbiology
Lab (26* x 35' r.
12').
25
Vented to
sewer drain.
1-4
Sterilization
conducted in
production area
(601 x 90' x 8').
JO
Vented to
sewer drain.
1-4
Sterilization
conducted in
separate room
(13* x 22* x 9').
70.9
Vented to out-
side atmosphere.
1-4
Sterilisation
conducted in
separate room
<19* x 16* x
12').
-------
TABLE C-2 (CONCLUDED)
aIndicates a range of the total number of persons authorized to operate ETO sterilization
equipment at this facility, unless otherwise indicated.
^Data in this column apply to all ETO sterilizers, ETO work areas, or ETO sterilizer operators
at this facility, unless otherwise indicated.
CWhere indicated, the dimensions of ETO work areas or ventilation/aeration areas represent
length x width x height.
^This represents cubic feet per minute (cfm).
^his represents pounds per square'inch gauge. A gauge pressure is the difference between a
given pressure and that of the atmosphere (Perry 1950).
^Tethered personnel refers to those personnel wearing air-line respirators. Air-line respirators
consist of a facepiece or head-covering helmet or hood to which air is supplied from a source
of compressed air (Sax 1979).
^Grade D breathing air is an OSHA requirement for air quality and is described in Commodity
Specification G-7.1-1966 of the Compressed Gas Association.
^o present an orderly sequence of the operating procedures followed at this medical products
firm, and due to the general nature of some of the data reported by this firm, complete data
on work practices and partial data on equipment design are presented under the Work Practices
column.
^The results of these changes for the two locations are:
Before After
Bulk Product Sterilization (8 Hr. TWA) (8 Hr. TWA)
A. Sterilizer Operators 25 2.2
Quality Control Personnel 23 1.6
Packaging Personnel 29 2.4
B. Sterilizer Operators 12 8
-------
TABLE C-3
PRACTICES RELATIVE TO WORKER EXPOSURE AT
SELECTED LIBRARY SITES
Facility/
Locat ion
Srerllitatloo/FualgatioQ Equipment*
Total
Number of
Operators^
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Siz« (ft3}/
Age (vean)
Scerilaot
Used
Cat Removal
System
Equipment
Design0
Workplace
Design
Work
Practices
Lhicjtfi)
Historical
Society
Chicago,
1L.
Vacudyne/
18/3
12Z ETO
88Z fTtotP
Exhausted via
hose through a
window pane to
the outside
atmosphere.
One at a
time but
total number
unknown.
No regular inspectior
or maintenance pro-
graa which may result
In undetected leakage
Fumigation conducted
in unrestricted area.
Limited air ventila-
tion and circulation
in area.
Treated material left
in closed chamber for
1-24 hours after con-
clusion of cycled
No time delay between
opening of door and
unloading the chamber.
Aerated in storage
area-
No operator training
program.
No protective gear
worn while operating
chamber.
One post-vacuum.
None
None
None
SOURCE: Brubaker, 1978; 1980.
-------
TABLE 03 (.CONTINUED)
Sterilization/Fumigation Equipment*
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Sire (ft3!/
Age (yeara)
Sterilant
Used
Gas Removal
System
Total
Number of
Operators*5
Potential
Exposure Situations
Equipment
Design0
Workplace
Design
Work
Practices
Monitoring of
Workplace for ftesidual
Levels of ETO
Harvard
Jnlversity
5ambridge,
4A.
Vacudyne/
18/2
12Z ETO
88Z Freon®
Exhausted via
a pipe Co out-
side sCmosphss-
2
No tegular inspection
and maintenance pro-
graa which may result
in undetected leakage*
Treated material left
in closed chamber 1 tc
48 hours after com-
pletion of cycle/*
No time delay between
opening the door and
unloading Che chamber'
No aeration facility;
treated material
shelved or sent to
Preservation Section.
No protective clothing
worn while operating
chamber.
One post-vacuum.
Fumigation con-
ducted in re-
stricted area.
In-house operator training.
None
SOUKCE: Preitag, 1980.
-------
TABLE C-3 (CONTINUED)
0
1
M
O
Sterilisation/Fumigation Equipment*
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Site (ft3)/
Age (year#)
Starllaoe
Used
Gas Removal
System
Total
Number of
Operators*1
Potential
Exposure Situations
Equipment
Deslgnc
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
ierbert Hoover
Institute
Stanford,
:a.
Vacudyne/
100/2
12Z ETO
881 Preon®
Exhausted via
pipe to outside
atmosphere.
1
Mo regular inspection
and maintenance pro-
gram which nay result
In undetected leakage.
Limited rooa
ventilation.
Aerated in storage
area.
Mo protective gear
worn while operating
chamber.
Two succesive post-
vacuums .
Fumigation con-
ducted in re-
stricted area.
Operator trained by
manufacturer.
Occasional checks for leakage
by the Stanford University
Bealth Officer.
Time delay between opening
of door and unloading of
chamber.
None
SOURCE: Pal*, 1978; 1980.
-------
TABLE C-3 (CONTINUED)
0
1
o
00
Sterilization/Fumigation Equipment*
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Siie (ft3)/
Age (years)
Sterilant
Used
Gaa Removal
System
Total
Nuaber of
Operatora^
Potential
Exposure Situation*
Equipment
Design0
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ET0
Library of
Congress
Washington.
D.C.
Devine/
420/22
101 ET0
901 C02
Exhausted via
a Metal pipe
Co outside
atmosphere.
Two at a
tlae, total
of four.
Mo aeration facility;
treated Materials
left in hallway until
shelved.
Two to three suc-
cessive post-
vacuums.
Air exchange
every 20 minutes.
Fresh air inlet
above chamber,
exhaust system
behind chamber
and on the wall
to the left of
chamber.
Fuaigatlon con-
ducted in re-
stricted area.
Periodic ln-house inspection.
Soap solution used for leak
testing.
Time delay of 1 to 24 hours
between first opening of door
and unloading of treated
items.
In-house operator training.
Gloves and coats worn while
operating chamber.
Most recent monitoring
was about 4 years ago.
Charcoal tube used to
monitor ET0 levels in
the air.
Very low levels (0.5
ppo) detected.
SOCBCE: HcComb, 1980.
-------
TABLE C-3 (CONTINUED)
0
1
o
VQ
Facility/
Location
Sterilizatlon/FuMigation Equipaent*
Total
Niaber of
Operators1*
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Gas Reaoval
Syitesi
Equipment
Des ignc
Workplace
Design
Work
Practices
Maine State
Archives
Augusta,
ME.
Vacudyne/
90/10
101 BTO
90Z C02
Spent gas
passed through
a water wash
before ex-
hausted to out-
side atmphere.
2
No regular inspection
and Maintenance pro-
gram say result is un-
detected leakage.
No ventilation in
chamber too*.
Fualgation conducted
in unrestricted area.
No protective gear
vora while operating
the chaaber.
No aeration facility.
Two to three suc-
cessive post-
vacuuma.
None
Operator trained by
manufacturer.
Chamber room equipped with
eaergency breathing gear.
Tine delay of 6-24 hours
between opening of door and
unloading chaaber.
None
SOURCE: Clark, 1978; 1979; 1980.
-------
TABLE C-3 (COHTINDED)
0
1
Sterilitatioa/Fiaigatioa Equipment*
Control Measures Implemented
Facility/
Location
Equipment
Manufscturer/
Sire (ft3)/
Age (years)
SterLlaat ¦
Used
Gas Rcsovil
System
Total
Number of
Operators^
Potential
Exposure Situations
Equipment
Designc
Workplace
Design
Work
Practice*
Monitoring of
Workplace for Residual
Levels of ETO
Massachusetts
Historical
Society
Boston,
MA.
Vacudyne/
18/8
12Z BTO
881 Freon®
Exhausted
to outside
•Cwtpbere.
2
Fumigation conducted
in unrestricted area.
Tlae delay of 24 hours
between opening of
door and unloading of
chober. Operator
work stations located
in same room as
sterilizer.
No protective clothing
worn while operating
the chsaber.
No aeration facility.
No operator training
program.
One poat-vacuum.
Area is air-
conditioned.
Fuse hood in-
stalled 2' above
the chamber door.
A fan Installed
across from
chamber.
Equipment serviced once per
year.
Gasket replaced twice a year.
None
SOUICS: Bantley, 1978; 1979;-1980.
-------
TAU.Z C-3 (CONTINUED)
Facility/
Locat ion
Steri1lea t ton, F umigat ioQ Equipment3
Total
Number of
Operators^1
Potent Lai
Exposure Situations
Control Measures Imp ietcented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Sire (ft3)/
Age ''years)
St er ilant
Used
Gas Removal
System
Equipment
Des ignc
Workplace
Des ign
Work
Pract ices
National
Archives
Washington,
!>.C.
f;udrditec'
300/43
10* ETO
90% CO2
Exhausted via
metal pipe
to outside
atmosphere.
1
Fuioi^at ion conducted
in unrestricted area.
No ventilation in
furtigation room.
No regular inspection
and maintenance pro-
gram may result in
undetected leakages-
Treated material left
in closed chambers for
several hours after
completion of cycle-**
No time delay between
opening of door and
unloading the chamber.
No protective clothing
worn while operating
chamber.
No aeration facility.
One post-vacuum.
Area equipped
with sprinklers
in case of f ire.
One floor tan installed for
use in the sunmer months.
In-bouse operator training.
None
SOURCE: Gear, 19 78; 1980.
-------
TABLE C-3 (COFrmOED)
0
1
K>
Sterillzation/Fimlgation Equipment*
Control Measures Iapleaented
Facility/
Location
Equipment
Manufacturer/
Site (EC3)/
Age (years)
SteriUnc
Used
Gas Removal
Systea
Total
Huaber of
Operators'*
Potential
Exposure Situations
Equipment
Designc
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Mew England
DOCUMBt
Conservation
Center
Adorer,
Vacudyne/
100/5
121 ETO
88Z Freon®
Exhausted via
pipe to outside
ataosphere*
1
Ho regular Inspection
and maintenance pro*-
gran wtoicfa may result
in undetectable*
leakage.
Mo protective clotbli^
worn while operating
chaster.
Ho tiae delay between
opening of door and
unloading chasber.
Ho aeration facility.
One post-vacuu.
Custoa designed
truck Mounted
chaaber.
Three large doors
opened during the
operation of
chaaber*
In-house operator training
prograa.
Hone
SOURCE: Ogden, 1979; 1980.
-------
TABLE C-3 (CONTINUED)
0
1
u>
Sterilization/Fumigation Equipment3
Control Measures implemented
Facility/
Location
Equipment
Manufacturer/
Size (ft3)/
Age (years)
Sterilaat
Used
Ga-s Removal
System
Total
Number of
Operators
Potential
Exposure Situations
Equipment
Des ign c
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
North
Carolina
Archives and
Record
Section
Raleigh,
NC.
Vacudvne/
300/11
102 ETO
90Z C02
Exhausted
to outside
atmosphere.
2
Fumigation conducted
in unrestricted area.
No regular inspection
and maintenance pro-
gram which may result
in undetectable
leakage.
Limited chamber room
ventilation.
Mo protective clothing
worn while operating
chamber*
Treated material
aerated in storage
area.
Equipment fitted
with an Internal
exhaust system
which is operated
for 12 hours after
conclusion of
cycle.
One post-vacuua.
None
Operators trained by
manufacturer.
Time delay of several hours
between opening of door and
unloading of chamber.
None
SOURCE: Hoffman, 1978; 1979; 1980.
-------
TABLE C-3 (COWTOBJB))
0
1
Sterlllzatlo«/?mig«tioa Equipment*
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Sice (ft3)/
Age (years)
Sterilant
Used
Cu Imoval
Systsa
Total
Muaber of
Operators**
Potential
Exposure Situations
Equipment
Design^
Workplace
Design
Work
Practices
Moaitorlng of
Workplace for Residual
Levels of STO
Pennsylvania
State
Archives
Harrisburg,
PA.
Vacudyne/
270/13
12Z ETO
88Z Ft eon®
Exhausted
to outside
atmosphere-
3
No regular inspection
and Maintenance pro-
gram which uy result
In undetectable
leakage.
Liaited chanber rooa
ventilation'
Fuaigatlon conducted
in unrestricted area.
No protective clothing
worn while operating
clmber.
Treated arterial
aerated in storage
area.
Three successive
post-vacuuas.
None
Tine delay of several hours
between opening of door and
unloading the chamber.
Operators Initially trained
by chober Manufacturer.
State approved breathing
apparatus readily available
in case of emergencies-
None
SOURCE: Sbelley. 1978; 1979; 1980.
-------
TABLE C-3 (OOBTIHUSD)
0
1
in
Sterilization/Fumigation Equipment*
Control Measures Implemented
facility/
Location
Equipment J
Manufacturer/ [
Size (ft3)/
Aga (year*)
Sterilant
Used
Gm Removal
System
Total
Nuaber of
Operators?*
Potential
Exposure Situations
Equipment
&esignc
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Pciui«7lv«oli
State
University
Pattee
Library
University
Park,
tA.
Vacudyne/
18/6
12X ETO
88Z Freon®
Exhausted via
pipe to outside
atmosphere.
One at a
tlme-
Total nuaber
unknown.
Mo regular inspection
and maintenance pro-
gram may result in
undetectable leakage.
Limited chamber room
ventilation.
Fumigation conducted
In unrestricted area.
Treated material left
in closed chamber for
several hours after
completion of cycled
Ho time delay between
opening of door and
unloading chamber.
Mo aeration facility.
Ho protective gear
worn while operating
chaaber.
No operator training
program.
One post-vacuum.
Hone
Hone
None
SOURCE; Felllpelli, 1980.
-------
TABLE C-3 (CONTINUED)
0
1
ON
Surilltatlu/Fualgatioa Equlpmat'
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterllant
Used
Gas Reswval
System
Total
Number of
Operators1*
Potential
Exposure Situations
Equipment
Deslgnc
Workplace
Des igfl
(fork
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Wisconsin
State
Historical
Society
Madison,
WI.
Vacudyne/
300/10
12X ETO _
86Z Freon®
Exhausted
to outside
atmosphere.
1
Mo regular inspection
and maintenance pro-
gran say result in
undetectable leaJcage.
Limited ctunber rooa
ventilation.
Treated material left
in closed cbraber for
several hours after
completion of cycle.^
No time delay between
opening of door and
unloading the chamber.
Treated material
aerated in storage
area*
Mo protective gear
worn while operating
chamber.
One post-vacuum.
Fumigation con-
ducted In re-
stricted area.
Operator trained by chamber
•manufacturer.
Hone
SOURCE: Hohler, 1980.
-------
TABLE C-3 (CONCLUDED)
I
fumigation cycle operated at negative pressure unless otherwise noted.
Refers to the total number of persons authorized to operate ETO fumigation equipment.
°Fumigation and air-wash cycles manually operated unless otherwise noted.
^Continued offgassing during this period may result in elevated ETO concentrations
in the chamber. Operators unloading the chamber may be exposed to these concentrations.
-------
TABLE C-4
PRACTICES RELATIVE TO WORKER EXPOSURE AT
SELECTED MUSjJDM SITES
SteriliEation/Pumlgatiou
Equipment*
Control Measures Implemented
facility/
Location
Equipment
McnufacCurer/
Sl« (ft3)/
Age (years)
Sterilant
Used
Gas Removal
System
Total
Number of
Operators**
Potential
Exposure Situation*
Equipment
Design6
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Lincoln
Mesorial
University
Barrogate,
TN.
Vacudyne/
64/3
m ETO
88Z Freoo®
Exhausted via
duct to
ataaosphere.
I
Mo regular inspection
or maintenance pro-
gram which say result
in undetected leakage.
Fimigation conducted
in unrestricted area.
Limited rooai
ventilation.
Treated material left
in closed chamber up
to 48 hours after coo-
elusion of cycle.^
Mo time delay between
first opening of door
and unloading of
treated material.
Chamber unloaded
manually.
No aeration of treats
material.
A "back-flow meter*
fitted into gas
vent hose to moni-
tor any backups
during exhaust
process.
One post-vacuum.
None
Protective mask, gloves and
lab coat worn while operating
chamber.
la-house training program.
Ocassional test for leakage
by (1) checking gas gauge at
beginning and end of cycle
for loss of pressure and (2)
using soap solution around
seals and fittings*
None
SOURCE: Archer, 1978; 1979; 1980.
-------
TABLE C-4 (continued)
S te rlIieatiMi/PuaigaCioo
Equipment*
Control Measures Implemented
Facility/
Locat ion
Equipment
Manufacturer/
SUe (ft3!/
Age (years)
Sterllant
Used
Gas Removal
Systea
Total
Humber o£
Operators
Potential
Exposure Situations
gqulpment
Design
Workplace
DesIga
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Lovie
Museum of
Aothr^polosy
Berkeley,
CA.
Vacudyne/
486/4
in BTTO ~
Ml Freotf5
Exhausted via
water-sealed
vacuum pomp to
sever.
i
8o protection gear
worn while operating
chamber.
Chamber unloaded
manually-
Ho aeration oC
treated material.
Op to 5 successive
vacuums say be
drawn at the con-
clusion of the
cycle.
Chsaber counted
in a 21' standard
highway seal-
trailer vehicle-
Trailer equipped
with 4 vents
a fan-
Routine in-house Inspection
o£ equipment -
Equipment checked period!-
cally by pest control officer.
Hallde detectors used to
detect leakage.e
Tine delay of 1-4 hours be-
tween first opening of door
and removal of treated
material.
In-house training prograa.
Fumigation equipment and
procedures periodically
checked by University Envi-
ronmental Safety and Health
Dept.
Monitored when equip-
Kent initially
installed.
Monitoring equipment
available froa
California OSHA Dept.
SOURCE: Brown, 1979; 1980.
-------
TABLE C-4 (CONTINUED)
r>
i
i-*
N»
O
Sterilisation/Fumigation Equipment®
Control Measures Implemented
facility/
Location
Equipment
Manufacturer/
Sire (ft3)/
Age (years)
Sterilant
Used
Gas Removal
System
Total
Number o^
Operators
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Muaeimi of
History and
Techoology
Washington,
D.C.
AHSCO1/
50/5
12X ETO
88% Treon
Exhausted via
a "condenser"
where spent gas
is mixed with
running cap
water, which ia
then conducted
to sewer drain.
3-4
Ho aeration of
treated material.
Equipment modified
to automatically
draw up to 5
successive post-
vacuums.
Ftmilgation con-
ducted in re-
stricted area.
Alarm on chasiber
room door which
alerts guards
whenever it is
opened*
Guards warned by
telephone when
authorized en-
trance is to be
made*
Illuminated safe/
unsafe warning
signs placed
above entrance
door activated b;
a switch in duct
detecting airflow.
Chamber room ven-
tilated with un-
conditioned air
at the rate of 1(
changes per hour.
Room vented at
floor level near
the point where
gas mixture
emerges to the
air, at nld-
height, and near
the ceiling.
Room air ex-
hausted to the
atmosphere*
Equipment serviced by manu-
facturer semi-annually.
"Kaltde detectors" used
around seals and gaskets to
monitor for leakage.e
Gauges monitored for any
drop in pressure during fumi-
gation cycle.
Protective gas mask worn
while operating chamber.
Polypropylene gloves worn
when handling gas cylinders.
Material loaded in a cart
which is wheeled into
chamber.
time delay of 30 minutes be-
tween first opening of door
and removal of treated
material.
In-house operator training
program.
Initial training by the
manufacturer.
Monitoring conducted
in 1978 using Wilks-
Miran 1R gaa analy-
zer. ETO concentra-
tion recorded in ex-
cess of 250 ppm upon
door opening.
Equipment and proce-
dures modified as a
result of the moni-
toring data. No
follow-up studies
have been conducted.
SOincn: CalaKao, 1979; 1980; Organ, 1979; 1980.
-------
THH c-4 (COKTIMUED)
0
1
ro
Seeriliaetlon/Timigatloa Bqulpwsnt*
Control Measures Inpleaented
Facility/
Location
Equipment
Manufacturer/
Site (ft1)/
Age (years)
Sterilant
u»«a
Gas Reaoval
Systes
Total
Huaber of^
Operators
Potential
Exposure Situations
Equipment
Design0
Workplace
Design
Work
Practice*
Monitoring of
Workplace for Residual
Levels of ETO
Museim of
Natural
History
Washington,
D.C.
4HSCO*/
100/25
101 ET0
901 CO]
Exhausted via
pipe to
itsoiphtre.
Ho regular inapectloo
or Maintenance pro-
gram which m»j result
la undetected leakage.
Restricted access but
potential passive ex-
posure to es^loyees
in loading area ad-
joining chamber row
due to a window sice
opening near chaaber
room door.
Llaited roaa
ventilation.
Ho protective gear
worn while operating
chaaber.
Ho operator training
program.
One post-vacuua.
Hone
Tine delay of several hours
between first opening of
door and removal of treated
Material.
Treated material transferred
frosi chaaber roaa to other
area with 8 to 10 air changes
per hour.
Noae
SODtCE: Pierce, 1980; Ruuell, 1980.
-------
TATU-K c-4 (OONTIHISD)
0
1
K>
to
Sterilization/fumigation Equipment*
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Dted
Gaa Removal
System
Total
Rusher of
Operator**3
Potential
Exposure Situations
Equipment
Deaignc
Workplace
Design
Work
Practice*
Monitoring of
Workplace for Residual
Levels of ETO
Museum of
Our National
Heritage
Lexington,
MA.
Vacudyne/
24/4
m STO
SSZ Freo^
Exhausted to
atmosphere.
4
Mo regular Inspection
or Maintenance pro-
graft which may result
in undetected leakage.
fumigation conducted
in unrestricted area.
Limited roam
ventilation.
Treated Material left
In closed cheaper foe
several hours after
conclusion of cycle.d
Ho time delay between
first opening of door
and unloading of
treated materials.
(To protective gear
worn while operating
chamber.
One post-vacuum.
Hone
Operators trained by
manufacturer.
None
SOURCE: Osborne, 1979; 1980.
-------
TABLE C-4 (COCfTHTOKD)
0
1
M
N>
Facility/
Location
Sterilixation/Fiaigatioa Equipment*
Total
Ruaber of
Operators^
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Sire (ft3)/
Age (years)
Sterilant
Used
Gas Removal
Sjrscw
Equipment
Design6
Workplace
Design
Work
Practices
Did Sturbrldgt
Village
Sturbridge,
UK.
•»
Kewaunee/
192/11
12Z ETO
SSZ Freon®
Exhausted to
atmosphere.
5-6
No regular inspection
or maintenance pro-
gram vhich may result
in undetected leakage
Fumigation conducted
in unrestricted area*
Limited roaa
ventilation*
Chamber unloaded
Manually.
Ho time delay between
first opening of door
and rooval of
¦aterlal.
Ko aeration of created
¦aterlal.
No operator training
progrm.
Three hour alr-
vash cycle run at
end of fiaalgation
cycle.
Exhaust fans in-
stalled in cham-
ber rooa for use
in the naner
months.
Hone
None
SOURCE: Curtis, 1979; 1980.
-------
TABLE C-4 (CONTINUED)
0
1
I-1
ro
4>
Facility/
Location
Sterilisation/Fumigation Equipment*
Total
Humber of
Operatorsb
Potential
Exposure Situation#
Control Measures Implemented
Monitoring of
Workplace for Kesldual
Levels of ETO
Equlptnt
Manufacturer/
SUe (ft3)/
Age (years)
Sterilant
Used
Gu ftemoval
System
Equipment
Design0
Workplace
Design
Work
Practices
tflnterthur
Museimi
Winterthur,
DE.
Unknown/
640/11
122 ETO
88Z Freon®
Exhausted to
Ataosphere.
I
Limited room
ventilation.
Bo protective gear
worn while operating
chamber.
Chamber unloaded
Mutually depending on
the type of material
being treated.
Ho tine delay between
first opening of door
and removal of
material.
No aeration of
treated material.
Twenty-four hour
air-wash cycle
performed at end
of fmlgation
cycle.
Fumigation con-
ducted in re-
stricted area.
Equipment serviced twice a
year.
Operator certified by the
State of Delaware.
Leakage tested via gas
chromatography.
Additional data not
available.
SOURCE: lcillr. 19"; 1480.
-------
TABLE C-4 (CONCLUDED)
Fumigation cycle operated at negative pressure unless otherwise noted.
^Refers to the total number of persons authorized to operate fumigation equipment.
CFumigation and air-wash cycles manually operated unless otherwise noted.
^Continued offgassing during this period may result in elevated ETO concentrations in the chamber.
Operators unloading the chamber may be exposed to these concentrations.
^alide detectors detect the presence of Freon® by a change in the flame color.
^Fumigation cycle operated at positive pressure.
-------
TABLE C-5
PRACTICES RELATIVE TO WORKER EXPOSURE AT
SELECTED RESEARCH LABORATORIES
Facility/
Location
Sterilisation/Fumigation Equipment
Total
Nuaber of
Operators^
Potential
Expoaure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Osed
Gaa Removal
Syatw
Equ ipment
Design0
Workplace
Design
Work
Practices
Charles River
Associates
Jilmlngton,
4A.
(1) Consolidated^
30/4-23
20Z ETO
802 COj
Spent gas.
16
Limited ventilation
In sterilisation area.
Treated material left
In closed chamber for
several hours after
completion of cycle A
No time delay between
opening of door and
unloading chamber.
Treated material
aerated in a holding
area.
Two successive
post-vacuums.
Chambers placed
between a sterile
and non-sterile
area.
Exhaust system
ttas been in-
stalled near the
chambers.
Protective gear worn while
operating chamber in sterile
area.
In-house operator training
prograa•
Regular Inspection and main-
tenance program.
4 Freon®detector is used to
detect leaks around fittings
and valves of the chambers .e
Continuous monitoring
of sterilization area.
Alarm is set off if
ETO concentration
levels exceed 50 ppo.
Save not registered
such levels yet.
(2) AMSCO/
80/4-23
(2) Hodges/
225/4-23
SOURCE: Fitch, 1980; Slater. 1979.
-------
TABLE C-5 (COHTIBUED)
0
1
M
hO
^s|
Facility/
LocatIon
Sterllitatloa/Fuaigatlon Equipment*
Total
Nuabef of
Operators^
Potential
Exposure Situation*
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Maaufecturer/
SUe (ft3)/
Age (years)
Sterllant
Used
Caa lauvtl
Syatsa
Equipment
Deslgnc
Workplace
Design
Work
Practices
Frederick
Cancer
Research
Center
(Aaiaal
Production
Facility)
Frederick,
MD.
(2) Castle/
36/26
12Z BTO
88X Freoe®
Spat gu ilza
vlth water and
disposed of as
ethylene glycol
to sewer.
1
Ho protective gear
worn while operating
chaaber.
Treated Material left
In closed chamber for
several hours after
coapletlon of cycle.*'
Ho tine delay between
opening of door and
unloading of chaaber.
Treated Material
aerated In the
chaaber room*
Multiple post-
vacuuaa.
Sterilization
conducted In
restricted area.
Rate of air
changes are 6-10
per hour Id the
chaaber rooa
area.
Exhaust systea
has been in-
stalled near the
chambers.
Eye goggles are worn while
changing gas cylinders.
Regular im-house Inspection
and maintenance prograa.
A Freon®detector Is used to
detect leaks around fittings
and valves of the chambers.6
In-house operator training
prograa.
Sterilization procedures
checked by the safety
department.
Continuous monitoring
of sterilisation area
with Wllks-Mlran 101
specific vapor
analyzer.
Alan is set off if
ETO concentration
levels exceed 50 ppa-
Have not registered
such levels yet.
In 1979 monitoring
was conducted using
charcoal tubes.
Samples of aahient air
were while
operator was operating
chaaber, unloading
chaaber and changing
gas cylinders.
Detected "very low"
levels of ETO in air.
SOORCB: Davis, 1980.
-------
TABLE C-5 (OUMTIHUKD)
0
1
00
Facility/
Location
Steril luttoa/F«lfttioa Bqalyemt'
Total
Mb«r of
Operators**
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Horkplace for Residual
Levels of ETO
KqnlfMBt
Manufacturer/
SUe (ft3)/
Age (year*)
Sterilant
D»ed
Cat Rwawl
Sjsts
Equipwmt
Design0
Workplace
Design
Work
Practice*
Frederick
Cancer
Research
(bnrlroB-
¦ental
Control ad
Research
Lab)
Frederick,
m.
(2) Castle/
12/2-26
(3) AMSCO/
20/2-26
(1) AMSCO/
45/2-26
12Z ETO
88Z Freoo*
Three units
vetted to the
outside ataos-
phere and 3 to
9
Ho protective clothlig
worn while operating
choker.
Ho operator training
program.
Ho tlae delay between
opening of door and
unloading of chanber.
Three successive
poet-vacuaas fol-
lowed by a 30
¦lnote alr-«ash
cycle.
Sterilization
conducted In
restricted area.
Rate of air
changes Is 6-10
per hoar In the
ih—her rooa
area.
Regular in-house Inspection
and maintenance progra.
Hone
SOOICE: Ul, 1980; Hanel. 1979; I960.
-------
TABLE C-5 (COHTIKUED)
n
I
M
NJ
VO
Facility/
Location
Sterillsatien/Fuitlgetioo Equlpitnt*
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Slit lit1)/
Age (years)
Sterilant
Ussd
Gaa icaoval
Systea
Total
Ruaber of
Operators^
tqnipaent
Besignc
Workplace
Design
Work
Practices
Jackson
Laboratory
Bar Harbour,
HE.
Castle/
30/7-18
122 STO
88Z Jreod*
Exhausted to
•afoaphere.
2
Sterilisation coo-
ducted In unrestricted
area.
Ro protective gear
worn while operating
charter.
Traatad Material left
la doted chamber for
several hours after
completion of cycle.d
Ho tiat delay between
opening of door and
unloading of chaaber.
One poat-vacuua.
Fimigatlon area
ventilated and
equipped vith an
exhaust fan.
Operator trained by
manufacturer.
In 1979 aonltorlag
was conducted using
Oraeger tubes.
ETO concentrations
between 20 to 50 ppa
were detected at the
breathing zone level
after chamber door was
opened at the end of
the cycle•
Veraleron/
4/7-18
SOUICE: Mirers, 1979; 1980.
-------
TABLE C-5 (COHTDDED)
raciurr/
Location
SttrlllMtlOB/ywlgitlwi Bqalpeat'
Total
¦oabar of
Operators*
Control Measures Tafil rnrnrnf
Monitoring of
Workplace for Residual
Level* of ETO
BqftlfMSt
Mwiifictarer/
Sice (ft3)/
Age (years)
Sterllant
Osd
Gas iMOnl
Sjstoi
Potential
bpcfgre SitMtloaa
Kqniyaent
Designc
Workplace
Design
liork
Practices
lationtl
Institutes
of Health
illaslcfl
•ad Infec-
tions
DiiCMf
Betbesda,
m.
3H/
2/3-4
10QZ DO
Exhausted via
copper robing
the
vail to the
atBocfhcre-
*-10
SteriH Mtiflo con-
ducted ia unrestrictet
area.
Limited ventilation
in sterilisation atea.
Mo portectlve gear
aorn while operating
chanber.
Treated material left
ia doeed chari>er for
several boors after
co^letion of cjclft.d
¦o tlae delay Imlia t ii
opening of door and
unloading of chanber.
Ho operator training
progm.
Aerator treats into
the workplace.
One post—vacuua.
Hone
Hone
lone
*/
2/3-4
SOOKX: Jms, 1979; 1980.
-------
TABLE C-5 (COKTDHJED)
0
1
OJ
Facility/
Location
Stcrilization/Fuelgation Equipment*
Total
Hin&er of
Operators'*
Potential
Exposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
SUe (ft3)/
Age (years)
Sterllant
Used
Gas Reaoval
Systca
Equipment
Deslgnc
Workplace
Design
(fork
Practices
Rational
Institutes
of Health,
Veterinary
Resources
Branch
tethesda,
!©.
Castle/
200/2
12Z ETO
88Z Freon®
Spent gas nixec
with water and
disposed of as
ethylene glycol
to sewer.
1
Sterilization con-
ducted In unrestricted
area.
Limited ventilation
In sterilisation area.
Treated material left
In closed chaaber for
a period of tiae after
completion of cycle.d
Mo regular inspection
sad aaintenance pro-
graa which nay result
in undetectable
leakage.
No operator training
program.
So protective gear
worn while operating
chaaber.
One post-vacuua.
Automatic door.
Treated material
unloaded into
"clean area"
where the rate
of air changes
Is 13 per hour.
Time delay between opening
of door and unloading of
chaaber.
None
SOURCE: Bolce. 1980.
-------
TABLE C-5 (CONCLUDED)
Sterilization cycle operated at negative pressure unless otherwise noted.
^Refers to the total number of persons authorized to operate sterilization equipment.
Sterilization and air-wash cycles manually operated unless otherwise noted.
(J i
Continued offgassing during this period may result in elevated ETO concentrations in
the chamber. Operators unloading the chamber may be exposed to these concentrations.
eHalide detectors detect the presence of Freon®by a change in the flame color.
-------
TABLE C-6
PRACTICES RELATIVE TO VOSKBt EXPOSURE AT
SELECTED TRANSPORTATION SITES
Steriliratlon/Pumigatlon Equipment
Control Measures Iaplesented
Facility/
Location
gqalf snt
Manufacturer/
Site (ft3)/
Age (years)
Sterilant
Used
Gas Rcaoval
SyiCai
Total
Rubber of
Operators
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
AMTRAK
UashiiigcoD,
D.C.
a
Mot applicable.
10Z ETO
90Z CO}
Hot applicable.
Bone
Hot applicable.
Cars to be fumi-
gated are aoved
to a separate
track.
Funigation procedures con-
tracted to a professional
extermination fin*
Protective gear, i.e., gas
Bask, is worn by the operator.
All openings except for exit
door sealed with gun tape-
Warning signs place around
the car during the fumiga-
tion process.
Car ventilated to open air
at the completion of fialga-
tioo process.
tester klts^ employed
to monitor Interior
of cars after aeration
to detemlne ETO levelf
("safe" levels must be
obtained before cars
returned to service).
*The procedure for fuslgation of passenger cars entails release of ETO in the ear awl does not entail use of equipment such as a fialgatlon ehanber.
^Gas Detector Kit, Model Hiaber SG 4010 and Dectector Tubes, Model Kurter SG 4100-163 are manufactured by Liquid Industrial Gases, Chicago, Illinois.
SOOKCE: McKenzie, 1979; Paloko, 1979.
-------
TABLE C-7
PRACTICES RELATIVE TO WORKER EXPOSURE AT
sinjtmm MRtnnPfwrr SITES
0
1
i-1
U>
¦C-
Sterilisation/Fumigation Eqalpaent
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
SUe (ft3)/
Age (years)
Sterilant
Deed
Gas Removal
System
Total
Ihnber of
Operators'
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Alabama***
Modified AMSCO
Chamber/
32/10
10Z ETO
9QX COs
Vented above
chamber via 8
ft. long pipe.
4
Treated material hand
carried'
Two successive
post-vacuums.
Fumigation and
aeration con-
ducted outdoors.
Chamber door left open for 3D
minutes before unloading.
Regular maintenance program.
None
California*1 **
Miskoe/
49/1
10Z ETO
901 CO3
Vented through
a 50 ft- hose.
Not available.
Hone
Two successive
post-vacuums.
Fumigation and
aeration con-
ducted outdoors.
Chamber door left open for 10
minutes before unloading.
Rubber work gloves worn when
handling material.
Pallet used in loading and
unloading chamber.
Operators trained by
California Dept. of
Agriculture.
Regular maintenance program.
Initially conducted
by Calif. Dept. of
Worker Health and
Safety; ao data
available.
SOOftCE: *kandall, 1980 and OSM, 1978; **Saith, 1980 and Vanderpool. 1980.
-------
TABLE C-7 (CONTINUED)
0
1
H»
OJ
Ln
Sterllizatlon/Fuaigaeion Equipment
Control Measures Implemented
Facility/
Location
Equipaent
Manufacturer/
Sice (ft3)/
Age (years)
Sterilant
Used
Gaa Removal
Systca
Total
¦uabcr of
Operators'
Potential
Exposure Situation*
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
birf
Connecticut
HoMMde/
64/4
100Z BTO
(chamber ii
Initially
flushed
with 002 to
air)
Ataospherlc
chaaber, no
evacuation
system.
Vented by re-
moving 4* s 4"
chaaber door.
Dpon rraii irial of door
at conclusion of
treataent period.
Hone
Fialgatlon and
aeration con-
ducted outdoors.
Chamber door left open 12
hours before half the load
is removed; remainder removee
after additional 12 hours.
Regular aaintenance program.
None
Delaware****
Modified AMSCO
Chaaber/
12/10
101 ET0
901 Cl>3
Vented 71a pipe
through roof to
ataospbere.
1
Hone
Pour successive
pos t-vacuums.
Double door chaa-
ber vith interior
fan which operates
after chaaber doox
opened to dissi-
pate BIO.
Puadgation and
aeration con-
ducted in garage
with restricted
access
Vent fan operate
during fualgatld
and aeration.
Chaaber doors left open vith
fan operating for 20 minutes
before unloading.
Regular aaintenance program.
None
SOURCE: *Paraer, 1980 and Kevtoa, 1980; MIomu, 1980.
-------
TABLE C-7 (CQHTIMDED)
Sterilisation/Fumigation Eqolpaat
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Site (ft3)/
Age (year*)
Sterilsnt
Used
Gas Bemoval
System
Total
Humber of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Maryland^
Miskoe/
49/4
10s ETO
90Z 002
Vented via
40 ft. long hose
Chumber unloaded la-
med lately after
opening.
Treated materials are
haod-carried-
One post-vacuum.
Fumigation con-
ducted outdoors;
aeration con-
ducted outdoors
or in shed.
Regular cleaning and
maintenance program.
None
MaryLand°**
(Bioeovi-
rotmeata2
See
Laboratory)
AKSCO (hospital
mattress
disinfeetor)/
86/13
I2Z ETO
881 Freon®
Vented to
outside of
greenhouse,
Treated materials
occasionally are
band-carried.
One post-vacuum.
Fumigation con-
ducted in
greenhouse-
Chamber door generally left
open for 24 hours before un-
loading; on occasion, cart
is pulled out immediately.
Regular cleaning and
maintenance program.
Hone
SOURCE: *Vaodea Posehe, 1980; **Kdox, 1980; ShimanuJcl, 1980 and USDAt 1978.
-------
TABLE C-7 (CCKTDIDED)
Sterilisation/Fumigation Equipment
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Sl«e (ft3)/
Age {years)
Sterllant
Used
Gas Removal
System
Total
Niaber of
Operators'
Potential
Exposure Situation*
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Mississippi0*
Miskoe/
49/4
10Z ETO
901 CO}
Vested through
SO ft- long bose-
3
Chamber unloaded im-
mediately after open-
ing chaaber door.
Treated materials
hand-carried.
One post-vacuum.
Ptnigation con-
ducted outdoors;
aeration conductei
outdoors or in
shed.
Treated materials not used
for 24 hours after fumigation
Regular cleaning and
maintenance program.
None
New .
Hampshire1*'*1
Miskoe/
49/5
10Z ETO
90Z C02
7a ted through
50 ft. long hose
Leading to out-
side of garage-
1
Treated materials
hand-carried•
One post-vacuum.
Vacuum pimp
operates for a 20
minute period
after chamber
door is opened.
Fxalgation con-
ducted In three-
sided garage.
Garage ventilated
through hole in
open vail.
Chamber door left open for 20
minutes before unloading.
Use hooked pole to pull pal-
let out of chamber.
Regular cleaning and
maintenance program.
Treated material aerated in
garage for a minimum of 24
hours.
Chamber operators are certi-
fied pesticide applicators.
None
SOURCE: Fulton, 1980; **Keating, 1980 and USDA, 1978.
-------
TABLE C-7 (CONTIMUED)
0
1
to
oo
Sterilisation/Fumigation Equipment
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Size (ft3)/
Age (years)
Sterilant
Used
C, aa Removal
Systa
Total
Number of
Operator**
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
New Jersey*"*
AMSCO (experi-
mental model)/
126/9
102 ETO
902 (X>2
Vented to roof
of building.
3
Limited room
ventilation.
Treated material is
aerated 15-20 ft.
from chamber in
warehouse.
Treated Material
hand-carried.
One door of cham-
ber located on
inside of ware-
house; the other
door opens out*
aide of warehouse.
Two successive
pos t-vacuuma.
High-ceilings in
warehouse.
In summer, both chamber
doors are opened; in winter,
only door in warehouse is
opened.
Chamber door left open for
30 minutes before unloading
chamber. \
Regular cleaning and
maintenance program.
None
New Jersey*-*
Hlskoe/
49/1
102 ETO
902 CO2
Vented through
dump valve im-
mediately out-
side chsmber.
Several,
although
only oper-
ator per
load.
Treated Material
hand-carried.
Two successive
post-vacuums.
Fimigation con-
ducted outdoors.
Chamber door left open for
30 mioutes before unloading
chamber.
Regular cleaning and
maintenance program.
None
SOURCE: ^Catthenious, 1980.
-------
TABLE C-7 (CONTINUED)
0
1
vO
Srerilisation/FumlgatLoa Equipment
Control Measure* lap lenient ed
Facility/
Locj t ion
Equipment
Manufacturer/
Sin- (ft3>/
Age (year*)
Sterilant
Used
Gat Removal
System
Total
Nuaber of
Operator*8
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Yofkh*
Homemade/
30/5
12Z ETO
88Z Freon®
Vented through
1 ft.long pipe
directly above
chamber.
4
Treated materials
hand-carried*
None
Fualgatlon con-
ducted outdoors;
aeration con-
ducted outdoors
or in shed -
Chamber door left open for
20 minutes before unloading.
Hooked pole used to pull
pallet out of chanber.
Regular cleaning and
maintenance program.
Treated material aerated for
a minimus of 6 hours•
None
North
Carolina^**
Miskoe/
49/Not available
10Z ETO
90Z CO?
Vented through
a SO ft. long
hose.
1
Treated material
hand-carried.
Two successive
post-vacuums.
Fumigation con-
ducted outdoors.
Aeration con-
ducted outdoors
er in shed.
Operators wear rubberized
gloves.
Chamber stands vlth dump
valve open for 24 hours
before unloading •
Regular cleaning and
maintenance program.
Treated material aerated for
a minimal of 24 hours-
None
SOURCE: *Stevens, 1980; **Chiotakis* 1980 and Green, 19&0.
-------
TA&LE C-7 (CONTINUED)
Sterilization/Fumigation Equipment
Control Meaaurea Implemented
Facility/
Location
Equipment
Kanufacturer/
Sire (ft3)/
Age (years)
SCerilaat
Used
Ci« Reaoval
Syita
Total
Nuatoer of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practlcea
Monitoring of
Workplace for Residual
Levels of ETO
b, A.
Oregon ^
Miskoe/
45/2
10Z ETO
90Z 002
Vented through
10 ft long pipe
straight above
chamber.
2
Treated Material
hand-carried.
Two successive
post-vacuums.
Fumigation con-
ducted outdoors.
Aeration coo-
ducted in poly-
ethylene-coated
structure*
Chamber door left open for
30-45 minutes before unload-
ing clumber.
Operators use self-contained
breathing apparatus or gas
masks snd wear overalls and
polyethylene gloves.
Regular cleaning and
Maintenance program.
Treated material aerated for
a minimum of 24 hours.
None
Tennessee^**
Miskoe/
49/2
10X ETO
90Z COj
Vented through
hose to outside
of building*
1
No ventilation in
fumigation room.
Treated material
hand•carried.
Treated material
aerated In same room
as chamber (for a
minimum of 24 hours).
One post-vacuum.
None
Chamber door left open for
30 minutes before unloading
chamber.
Regular cleaning program.
None
SOURCE: *Port, 1980 and Turner, 1980; **Hart, 1980.
-------
TABLE C-7
-------
TABLE C-7 (COMTiKIJED)
St«riUtatioa/FwltatiM Equipment
Control Measures Implemented
Facility/
toe*ttoo
EqutpMQt
Manufacturer/
Sice (ft3)/
Age (years)
Seer ilaat
Died
Gas Removal
Systea
Total
Humber of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
West c
Virginia
Hiskoe/
49/Hot available
10X ETO
90Z 002
Vented through
damp valve im-
mediately out-
side chamber.
0»
Treated materials
band-carried.
One post-vacuum.
Fumigation con-
ducted outdoors.
Chamber door left open for
15-20 minutes before unload-
ing chamber.
Regular cleaning and main-
tenance when unit is in
operation.
None
sooacz: Cole, 1900.
-------
TABLE C-7 (CONCLUDED)
defers to the total number of qualified ETO operators at the facility, unless otherwise indicated.
^State which has an experimental use permit, as described in Section 5 (c) of FIFRA.
State in which ETO fumigation is restricted under the control of the state regulatory agency
responsible for apiary inspection, under the procedures described in Section 24 (c) of FIFRA.
^Chamber is operated privately, not under the supervision of Federal or state officials.
0
Chamber is state operated.
^Facility does not employ ETO chamber operator at present; therefore, fumigation program is not
currently being conducted.
-------
TABLE C-8
PRACTICES RELATIVE TO WORKER EXPOSURE AT
SELECTED HIGH CCVTAINKBNT RESEARCH LABORATORIES IH AGRICULTURE
Sterilisation/Fumigation Equipment
Control Measures Iuplesented
Pacllity/
Location
Equipment
Manufac turar/
Sl«e (ft3)/
Age {years)
Sterilant
Used
Gas Removal
System
Total
Number of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Naclonal
Animal
Disease
Ceoter
Ames,
IA.
(4) Homemade/
0.3; 3.3; 5.3;
30/10
12X ETO
88X Freoa®
Negative ex-
haust directly
into building
exhaust ducts*
3
Mo time delay between
conclusion of steri-
lisation cycle and
removal of treated
material fro* chambcs
Two successive
post-vactma.
General work
area is 4588.5
cubic feet.
Mechanical area
ventilation sys-
tem with 10 air
changes per hour.
Direction of air-
flow is to ex-
haust plena.
Safety unit personnel who
work with ETO are trained by
their supervisor.
Chamber valves and electrical
components checked annually.
Workers do not enter chamber:
to retrieve materials'
Certain treated rubber mate-
rials, such as boots, are
aerated.
None
SOURCE: Sullivan, 1980.
-------
TABLE C-8 (COKTMOED)
n
I
(-»
JN
Ln
Scerilizaeloo/Foiigation Equipment
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Sice (ft3)/
Age (years)
Sterllint
Used
Cas Removal
System
Total
Rusher of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Plant Disease
Research
Laboratory
Frederick,
MD.
(5) Wllmot
Castle/
3, 24. 30, 144,
220/25-30
12Z ETO
SK Freoi^
Steam ejector
•vacuators.
Exhausted
through vent
pipes to roof.
1-2
Workers may, on
occasion, enter the
two largest ch—hers,
Workers do not wear
protective clothing*
No regularly sched-
uled program of
equipment Inspection
and maintenance.
All chsnbers have
double doors.
Chaaber doors ere
automatically
locked when In-
ternal pressure li
greater than
2 lbs.
Mechanical area
ventilation
system.
Supply sir is
Introduced then
exhausted through
HEM. filters.
Air Is changed li
all rooma at the
rate of 5 times
per hour.
Direction of
general airflow
is from ETO work
area to nom-EIO
work area.
After gas Is vented and In-
terval pressure reaches zero,
wheel-lock mechanism is
operated to release door sea]
to permit residual gas to
bleed froi chamber.
During this period, operator
Is away from chamber door
sad In the path of fresh in-
coming air.
After a period of time*
chsber door Is opened and.
In most Instances, the rham-
ber is left to air out over-
night before the treated
materials are removed.
Chiber operator trained by
person in charge of building.
Chambers were recently
checked with detection
devices that were
sensitive to leaks at
a rate of 10~' cc/sec.
Additional data not
svailable.
SOOSCE: Irish. 1980.
-------
TABLE C-S (COHIMOED)
n
I
t—'
->
Sterllisation/Ftmigetioa Equipment
Control Measures Implemented
Facility/
Location
Equipment
Manufacturer/
Sice (ft3)/
Age (years)
Sterilsnt
Deed
Gee KomviI
Systoi
Totel
ftab«r of
Operators*
Potential
Exposure Situations
Equipaent
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
PliA Island
lalul Disease
Center
Greenport,
NT.
AMSGO/
26/8
12Z ETO
ggZ Fraon®
Vented to e*-
haust gystm.
1-2
Equipaent repaired by
engineering staff not
trained in ETO use
and dangers.
Two successive
poet-vacuuas.
Chaaber opened
fron building
exterior.
Aeration con-
ducted outdoors.
Single-passage
airflow systea.
Fifteen air
changes per hour.
Air in building
is filtered
through deep-bed
or BEPA filter
systas and dis-
charged through
stacks located
on roof.
911b on lab safety regula-
tions shown to all new
employees.
Sterilisation area restricted
to those employees who work
only in antes I supply.
Employees trained to check if
equipment functioning
properly.
Operators are safety
technicians.
Operators wear respirators
and rubber gloves.
Hone
AMSCO/
4/20
90DKCB: tldaad, 1980.
-------
TABLE C-8 (CONCLUDED)
defers to the total number of persons authorized to operate ETO sterilization equipment.
-------
TABLE 0-9
PRACTICES RELATIVE TO WORKER EXPOSURE AT
SELECTED PORTS OF EHTKT
o
I—*
^s
00
SterllitatiOft/FiMlgetion Equipment
Control Measures lapleaeated
Facility/
Location
Equipment
Manufacturer/
Sice (ft3)/
Age (years)
Sterilant
Used
Gas Rcaw>val
Systea
Total
Uuaber of
Operator**
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
Baltimore
Port*
Baltimore,
MD.
Hot applicable
10Z ETO
90Z C02
Mot applicable.
4-5
Not available.
Polyethylene
tarpaulin, which
varies in size and
say be reused 26
tiaes before it is
destroyed.
Tarpaulin, when la
use, is secured
with sand snakes
Fwlgation and
aeration con-
ducted outdoors.
Treated naterial handled by
forklift.
Warning placards and guard
posted during fualgation.
Gaa Basks available, but not
worn.
None
Dover Air
Force Ease**
Dover,
DE.
Not applicable
10Z ETO
90Z 002
Rot applicable.
4
Not available.
Polyethylene
tarpaulin
(40* x 100*).
Fimigation con-
ducted in hanger
Aeration con-
ducted In hangar
or outdoors (1/2
of hangar used
for fumigation;
other half used
for equipment
storage).
Gas Bask worn while cutting
and reserving tarpaulin.
Hew tarpaulin used for each
fumigation.
Treated material handled by
forklift.
Treated Material aerated for
a ainimua of 24 hours.
None
SOURCE: *Tllley, 1980; **Jemigan, 1980.
-------
TABLE C-9 (CONTINUED)
0
1
M
¦>
VO
Scerllieatlon/FuBigatioa Equlpnent
Control Measures Iapleaented
Facility/
Location
Equipment
Manufaccurer/
SUe (ft3)/
Age (year*)
Sterilant
U»ed
Gas Rcaoval
Systca
Total
Huaber of
Operators*
Potential
Exposure Situations
Equipment
Design
Workplace
Design
Work.
Practices
Monitoring of
Workplace for Residual
Levels of ETO
McGuire Air
Force Base*
Ricetown,
HJ.
Hot applicable.
101 ETO
90Z C02
Fan posi-
tioned under
tarpaulin.
3-4
Rot available.
Polyethylene
tarpaulin used
for fusigation.
Fuaigatlon con-
ducted in aain-
teaance garage
(with floor to
celling doors).
Aeration con-
ducted in garage
or outdoors.
Mew tarpaulin used for each
funigatlon.
Tarpaulin glued to floor
during fumigation.
Self-contained breathing ap-
paratus worn while cutting
and raovlng tarpaulin.
ETO evacuated by fans located
under tarpaulin.
Treated.Material aerated for
24 hours.
Treated Material transported
by forkllft.
Juadscope used to
¦onltor concentration
of ETO in garage after
reaoval of tarpaulin.
New Orleans
Port**
New Orleans,
LA.
Rot applicable.
10Z ETO
901 CO2
Fans.
4-5
Mot available.
Polyethylene
tarpaulin used
for fuaigation.
Fusigation and
aeration con-
ducted outdoors.
Tarpaulin may be used for up
to 4 fumigations.
At end of cycle, wet sand is
reserved froa borders of tar-
paulin (starting froa down-
vind side) and tarpaulin is
lifted. Fans are operated
for approxiaately 3 hours
before cargo is soved,
3as —ska worn during removal
af tarpaulin.
rreated Material transported
by forkllft.
None
SOURCE: •Ocrvssonl, 1980; **Bourgeois, 1980.
-------
TABLE C-9 (C0MT1NUED)
0
1
U1
o
Facility/
Location
Sterilisation/Fumigation Equipment
Total
Bumber of
Operators*
Potential
gsposure Situations
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETO
Equipment
Manufacturer/
Size (ft3)/
Age (years)
Steriiaat
Used
Gas Removal
Systea
Equipment
Design
Workplace
Design
Work
Practices
Nev Orleans
Port*
Nev Orleans,
LA.
Not applicable*
10Z ETO
90Z C02
Fans.
4-5
Hot available.
Polyethylene
tarpaulin used for
fisalgatioa.
Fuaigation and
aeration con-
ducted outdoors'
Tarpaulin used for up to 2
fumigations.
Warning placards and guards
posted during fumigation.
Gas Basks made available to
operators.
At conclusion of cycle, the
downwind corner of tarpaulin
is lifted, 6 to 8 fans ven-
tilate the load under the
tarp for 15 minutes, and tbes
the tarpaulin is removed.
Treated material transported
by forklift*
None
Men Orleans
Port**
Sen Orleans,
LA.
Not applicable*
101 ETO
90Z a>i
Not applicable.
4-5
Mot available.
Polyethylene or
double-ply, lain"
ated polyethylene
tarpaulin used•
Fumigation and
aeration con-
ducted outdoors.
Polyethylene tarp used for
up to 2 fumigations'
Double-ply laminated poly-
ethylene tarpaulin used for
up to 5 fligations*
Treated material transported
by forklift.
Gas TMffkfi made available to
operatorn.
One downwind corner of tar-
paulin lifted for 30 minute
period. Then other downwind
corner lifted for another 30
minutes. Finally, tarpaulin
is removed.
None
SOURCE: *I»blll, 1980; "Wilson, 1980.
-------
TABLE C-9 {CONTINUED)
0
1
U1
Facility/
Location
Sterllltatl
on/Fumigation Equipment
Potential
Exposure Situations
Control Measures Xapleaented
Equipment
Manufacturer/
Sire /
Age (years)
Sterilant
Used
Gas Removal
System
Total
Number of
Operators*
Equipment
Design
Workplace
Design
Work
Practices
Monitoring of
Workplace for Residual
Levels of ETO
New York
Port*
New York,
NY.
Not applicable-
101 ETO
902 C02
Wan*'
4-5
Not available.
Polyethylene
tarpaulin-
Fumigation and
aeration per-
formed outdoors
ot in abandoned
warehouse.
New tarpaulin used for each
fumigation*
Self-contained breathing ap-
paratus available to workers.
Warning placards and guards
posted during fumigation.
Treated material transported
by forklift.
One of two methods used Co
evacuate gas and aerate
material:
Fan attached to hose lead-
ing out of warehouse. When
reading of sero received on
fumlscope, tarpaulin
removed.
Opposite ends of tarpaulin
are lifted and fans, blow-
ing in the same direction,
are placed at each end.
This creates a draft which
continues for 15 minute*.
Then the tarpaulin is
removed.
None
Hew York
Port**
Hew York,
NY.
Hot applicable*
10Z ETO
9QZ CO}
Hoc applicable.
lot available
Not available.
Polyethylene
tarpaulin- '
Fumigation per-
formed in empty
warehouse.
Mot available.
Not available.
SOOUX: »irch, 1980 md Arch. 1980a; "lolbe. 1984.
-------
TABLE C-9 (CONCLUDED)
defers to the total number of persons authorized to operate ETO fumigation equipment.
-------
TAftLE C-10
PRACTICES RELATIVE TO WORKER EXPOSURE AT
SPICE ZMDOSTCT SITES
Ci
I
Ln
LO
Facility
Sterilization/Fumigation Equipment
Total
Number of
Operator*'
potential
Exposure Situations*
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOa
Sice of
Steriliser
(ft3)
Sterilant
Used
Gas Renewal
Systea
Equipment
Design
Workplace
Design*-*
Work
Practices*
Site A
384
1001 STO
Vented to
sever.
2
Operators tmloaH
steriliser immedi-
ately upon opening
of chamber door.
Treated materials
not aerated In
aerator or specially
designed aeration
rooa.
Two post-vacuums.
Steriliser
located in sepa-
rate room (12* *
30* x 15') with
1400 cfm mechan-
ical area venti-
lation (fans).
Access to ETC work area is
restricted to ET0 steriliza-
tion workers.
Pallets containing fumigated
materials are removed from
chamber by lift truck.
Vacuum pumps and process
cycle controller Inspected
dally.
In 1970,personnel from
division of industrial
safety and the Orange
County Division of
Environmental Health
performed tests to
check ET0 levels in
and about the chamber.
Additional data were
not available.
-------
TABLE C-10 (CONTINUED)
n
i
M
Ul
-O
Sterllixatioe/Fuaigation Equipment
Control Measures Implemented
Facility
Size of
Steriliser
(ft3)
Sterilant
Used
Gu FiBinyl
Syitai
Total
ttumber of
Operator^*1
Potential
Exposure Situations
Equipment
Design
Workplace
De»ign*"C
Work
Practices*
Monitoring of
Workplace for Residual
Levels of ETO
Site B
(2) 255
12X BTO A
88Z Fr eon®
Vented to seaer
drain and to
atmosphere.
1
Operator anst eater
chamber to
treated Material.
Treated materisle
(in containers) are
¦anually unloaded
from chamber to a
pallet.
(fcie poat-vacvua.
Vacuum pisp draws
ETO to water
scrubber. ETO
solution drained
to sewer and in-
ert gas vented to
ataao sphere.
Steriliser lo-
cated in open
space (401 x AO*)
away fro* general
work area (with
natural, open-
space ventila-
tion) .
ETO cylinders are
isolated from
steriliser.
Sterilised pro-
duct stored in
open air staging
area for short
period of time
prior to
delivery.
Access to ETO work area is
restricted to authorized
personnel.
A.t completion of sterilisa-
tion cycle, chaaber door is
left opened for 1 hour before
treated materials are re—
aoved*
Pallets containing ETO-
treated stater ials transferred
to open air staging area by
forfcllft.
Operator receives four weeks
of actual in-plant training
regarding safety, handling and
use of ETO cylinders, and
operation of sterilisation
chambers.
Chaaber door, ETO Isolation
valves, sir purging, and
exhaust system are inspected
daily.
Hone
-------
TABLE C-10 (COKTDIUED)
0
1
l~»
Ui
U!
Sterillsatlon/Faalgatloa Equipment
Control Measures Implemented
Facility
Size of
Steriliser
-------
TABLE C-10 (CtWtXUUED)
n
M
Ln
Ov
Facility
Sterillsatloa/Faalgatioa Equlpaent
Total
Huaber of
Operators4*
Potential
Exposure Situations*
Control Measure* Implemented
Monitoring of
Workplace for Residual
Levels of ETOa
Sice of
Steriliser
(ft3)
Sterilant
Used
6«* Reaoval
Systca
Equipment
design
Workplace
Design*»c
Work
Practices8
Site D
666
1002 ETO
Vented Co
sever drain.
1-4
Operators must enter
chaaber to unload
treated materials.
Quarantine area for
treated asterlals not
equipped with ven-
tilation system.
None specified
Steriliser loca-
ted in vork area
(eO'xZS'xl? 1/4*)
with mpchanfcal
area ventilation
and rate of air
exchange of 4333
cfm.d
Direction of air
flow is froa nott-
ETO area to ETO
work area to out'
side ataosphere.
Treated Material*
are stored in
designated quar-
antine area of
general ware-
house for 5
days.
At coapletion of cycle, cham-
ber door is cracked open for
IS alnutes (with vacuus pump
operating). Treated mate-
rials are not raoved until an
additional 30 minute period
has passed.
Operators receive an 8 to
12 week Initial training
program and periodic review
in quarterly training ses-
sions . These sessions are
held biweekly on standard
operating procedures, good
Manufacturing processes, and
safety.
Instruments are checked and
calibrated quarterly by
outside firm. Checked monthly
by internal plant engineer.
Monitoring being con-
ducted at present
(September 1980)
using Mine Safety
Appliance Co. Person-
nel Portable pump
and tfllks-Miran-101
Vapor Analyser.
Additional data were
not available.
1329
100Z ETO
Vented to
sever drain.
-------
TABLE C-10 (CONTINUED)
0
1
I—»
Ln
Sterilifcatioa/Fuaigation Egalpaent
Control Measures Iapleaented
Facility
Size of
Sterilizer
(ft3)
Sterllant
Used
Cu teaovil
Systea
Total
Nuaber of
Operators**'
Potential
Exposure Situation**
Equipment
Design
Workplace
Designa*c
Work
Practice*9
Monitoring of
Workplace for Residual
Levels of ET0a
Site E
533
12Z ETO
S8Z Ftcoh
Vented to
ataosphere
and to drain.
2
Access to ETO work
area is not
restricted.
Treated Materials
are moved froa
chaaber iaaediately
after opening of
"hnh-r door.
Treated spice
products are stored
In iiw area as the
steriliser.
One post vacuim.
Three air-washes.
Liquid/gas
separator.
Steriliser loca-
ted in general
storage area
(I20'xl20'xl2')
with aechonlcaJ
area ventilation
systea and rate
of air exchange
of 3100 cfa.d
Direction of air-
flow is through
storage area
to outside
ataosphere.
Operators have received
specific instructions on
operation of the steriliser
and hasards associated with
its use. Sterilizer opera-
tors report any deviations
froa noraal operating pro-
cedures to supervisor.
Monthly inspection and
maintenance prograa per-
formed, including inspection
of door gasket, door
securing handles, vacuus
puap seals, and other
parts.
Monitoring performed
using Ml ran 103 gas
analyzer on spot-
check basis. Facil-
ity reports that ETO
levels are "well
below" OSHA standard
of SO ppa.
-------
TABLE C-10 (CGWTIHDED)
Facility
Sterlllsatloa/Fualgatioa Eqalftnt
Total
Roriier of
Operator^**1
Potential
Exposure Situations*
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of Eltf
Size of
Steriliser
(ft9)
Sterilant
Used
Cas fteaoval
Systsm
Equipment
Design
Workplace
Design a'c
Work
Practices8
Site ?
533
12Z ETO
86Z PreoiP
Vented to
outside
ataospbere.
1
Access to ETO work
area is unrestricted.
TWo post VACUUMS.
Chamber equipped
with electrical
interlocks to
prevent opening
of cbaaber door
prior to coatple-
tion of cycle.
ETO work, area (20
z 30') located
In 72,000 ft3
warehouse with
mechanical area
ventilation sys-
tea with rate
of air exchange
of 28,000 cfa.d
At completion of steriliza-
tion cycle, cbaaber door Is
opened for 4S minutes be-
fore treated materials are
removed.
Treated Materials are
retrieved froa cbaaber
using a hook and chain sys-
tem over roller conveyors.
Treated materials are
transported to aeration
area using a forfclift.
Operators and other workers
attend training sessions on
ETO sterilisation followed
by periodic review and up-
date of safety and handling
procedures.
Current inspection and
Maintenance includes
weekly equipment inspection
and daily check procedures.
Maintenance is also sche-
duled based on check
required.
Monitoring of environ-
mental levels has
not been performed;
however, residual
ETO in products
sterilized is
monitored.
-------
TABT.E c-10 (CONTINUED)
0
1
U1
VO
Sterlllsatlea/?t*igAtlon Equipment
Control Measures Implemented
Facility
Size of
Sterilizer
(ft*)
Sterllant
tfsed
Cas Reaovsl
Systea
Total
Huaber of
Operators***
Potential
Exposure Situations8
Equipment
Design
Workplace
Design a,c
Work
Practices8
Monitoring of
Workplace for Residual
Levels of ET0a
Site G
560
1002 ETO
Vented to
sever drain.
2
There is no tiae
delay be twees open-
ing of chaaber door
and retrieval of
treated aaterials.
Two air purges.
Wben chamber
doors are
locked* mechani-
cal fan is auto-
matically placed
into operation
(location of
fan vas not
specified).
Sterilizer
located in
separate rooa
(32** 20* x 25*3
with aechanical
area ventila-
tion systea
and air ex-
change rate of
1,500 cfM.1
Aeration area
covered by cur-
tain doors lead-
ing to loading
dock (vieb
natural ares
ventilation).
Access to ETO sterilization
rooa is United to super-
visor of sterilization op-
erations, chaaber operator,
and other authorized super-
visory personnel.
Treated aaterials loaded
onto pallets.
At coapletion of cycle,
treated aaterials on pallets
are rolled out of chaaber
and transferred (using
forklift) to area near
loading dock.
Operators receive thorough
indoctrination on health
and fire hazards of ETO.
Operators are instructed
that in the event of chaaber
malfunction, treatment is
to be discontinued and aan-
ageaent is to be notified
Ijamediately*
Cursory onsite inspection
every tiae the chaaber is
to be operated. Continuous
Monitoring of control
panel recorder.
Monitoring of envi-
ronmental levels has
not been perforaed;
however, residual ETO
in products steri-
lised is aonitored.
-------
TAfcfK C-10 (COHTIOTED)
Sterillsatioa/Fialgatioa Equipagnt
Control Measures Iapleaented
Facility
Size of
Steriliser
(ft3)
Sterilant
Used
Cm Reaoval
Systea
Total
Muaber of
Operators**'
Potential
Exposure Situation*9
Equipment
Design
Workpls.ce
Designa»c
Work.
Practices3
Monitoring of
Workplace for Residual
Levels of ETO a
Site H
330
12Z ETC
881 Freoo®
Vested to
outside
ataosphere.
1-4
Sot Available.
One air flush.
Steriliser lo-
cated in work
area (22' x 20* x
16*) in plant
with mechanical
area ventila-
tion systea and
10 air changes
per hour.
Access to ETO work area is
United to ETO steriliza-
tion workers.
Treated material removed
froa chaaber using a fork-
lift and transferred to
designated (and ventilated)
aeration area.
Operators wear goggles and
respirators in ETO work
area.
Operators receive 3 aonth
training, and written
sterilization procedures
are posted on wall near
sterilizer.
Chaaber is checked on a
regular schedule for equip—
aent malfunction.
None
-------
TABLE C-10 (COMmUED)
n
I
(J*
Facility
Sterllisatl
oo/Fumigation Equipment
Potential
Exposure Situations
Control Measures Implemented
Size of
Sterilizer
(ft3)
Sterilsat
Osed
Gas Removal
System
Total
Nuaber of
Operators®^
Equipment
Design
Workplace
De«lgn*»c
(fork
Practices
Monitoring of
Workplace for Residual
Levels of ETOa
Site I
(2)800
100Z ETO
Vented to
sever.
2-4
Hot specified.
Three air purges.
Chamber equipped
with alarm moni-
toring system
(additional data
not reported) and
Interlocks to
prevent opening of
door prior to
coapletloo of
cycle.
Sterilisers lo-
cated In areas
that measure
30* x 24' x 15',
40' x 30' x 24*,
40* x 30* x 20',
and 40* x 30* x
18',respectively.
ETO work area foi
first 4 chambers
have mechanical
area ventilation
system with air
exchange rate of
5000 cfm;d other
ETO area has
passive area
ventilation.
Direction of air
flow is from ETO
area to non-ETO
areas at all 4
ETO work areas.
Access to ETO work area is
restricted to authorised
persoonel.
At co^>letloo of cycle,
chamber door is opened for
10 minutes prior to un-
loading treated goods.
Pallets moved to front of
chaaber using cables and
transferred to open area for
aeration using fork truck.
Protective clothing is
available for the workers.
Formalised training program
using posted procedures.
Sterilisation equipment in-
spected weekly by main-
tenance personnel.
Monitoring has been
conducted. Additional
data were not
available.
1400
100Z ETO
Vented to
sewer.
1600
100* ETO
Vented to
sewer.
ilOO
1001 ETO
Vol ted to
sewer.
-------
TABLE C-10 {CONTINUED)
n
ON
Ni
Surlllueioa/Fialgatioii EqulpMnt
Control Measures Implemented
Facility
Size of
Sterilizer
Sterilant
Used
Gas Kenoval
System
Total
Number of
Operators*^
Potential
Exposure Situations*
Equipment
Design
Workplace
Design*»c
Work
Practices*
Monitoring of
Workplace for Residual
Levels of ETO*
Site J
280
12Z BTO
881 Preon"
Vented to
atmosphere.
1-4
Hot available.
Two air washes.
Sterilizer lo-
cated In ware-
house (90* x 18'
x 50*) equipped
with Mechanical
area ventilation
system (exhaust
fan) and rate of
air exchange of
100 cf..d
Direction of air-
flow Is from non-
ETQ work area
towards ETD area
Exhaust vents
located beneath
chamber door.
Aeration room
ventilated with
exhaust fan.
Access to ETC sterilization
area is restricted to au-
thorized personnel.
At end of cycle, chamber
door is opened for 20
minutes (with exhaust fan
operating) before treated
materials are removed.
Operators vear cloth work
gloves or vinyl disposable
gloves.
Each worker is trained in
proper sterilization pro-
cedures* Facility has writ-
ten procedures manual.
Entire chamber mechanism
(gaskets, seals, joints,
exhaust, etc.) is periodi-
cally checked for defects.
None
-------
TABLE C-10 (COHTnrUEI)
0
1
I-1
ON
U)
Sterllizatloe/Fualgatioa
Equipment
Control Measures Implemented
Facility
Size of
Steriliser
(ft3)
Sterilaat
Used
Ge« Removal
Systca
Total
Nuaber of
Operator#8*11
Potential
Exposure Situations*
Equipment
Design
Workplace
Design* »c
Work
Practices*
Monitoring of
Workplace for Residual
Levels of ETC®
Site K
263
12Z ETO _
881 Freoa
Vented to
sewer drain.
2
Workers aust enter
chaaber to qiload
treated Materials.
Multiple post-
vacuuMS.
air washes.
Steriliser loca-
ted in shipping
rooa (90* x 70*
x 11') with pas-
sive area venti-
lation (cross
ventilation fro*
dock door and
windows near
chaaber area).
Direction of
airflow is from
noo-ETO work
area towards
ETO area.
Access to ETO area is
restricted to authorized
personnel.
At coapletlon of cycle,
chaaber door is opened for
20 Minutes prior to un-
loading of treated Materials.
Operators supplied with
cloth work gloves or vinyl
disposable gloves.
Operators trained in proper
sterilization procedures
and follow procedure aanual.
Begularly scheduled program
of equipment Maintenance
is per fonaed.
None
-------
TABLE C-10 (COMTXHUED)
O
I
M
o>
¦P-
Sterilisation/Fumigation Equipment
Control Meainres Iapleaeated
Facility
Sise of
Steriliser
(ft3)
Sterilant
Used
Cm Removal
System
Total
Huaber of
Opera tors**1
Potential
Exposure Situations*
Equipaent
Besi-gn
Workplace
De»igu*»c
Work
Practices'
Monitoring of
Workplace for Residual
Levels of ET0a
Sice L
921
12Z ETO
an rreoa®
Vented to out-
side atmos-
phere end
sewer drain.
1-4
Access to steriliser
and storage warehouse
areas is not to KTO
steriliser operators;
however, there Is a
"ainiaoa" of employee
traffic in steri-
lizer area.
Lift truck operator
aust enter chasfcer
to retrieve treated
aaterlals.
Three air washes.
Sterilizer loca-
ted In warehouse
(200* x 50* x
40*) with me-
chanical area
ventilation sys-
tems (exhaust
fans) and two
air changes per
hour.
Oirectioo of air
flow Is froa ETO
work area to mxr
ETO work areas.
Exhaust fan in
roof of aeration
area which oper-
ates continu-
ously, drawing
air froa this
area and exhaust
ing it to outside
atmosphere.
At coapletlon of cycle,
chaaber door is opened ap-
proximately 1 foot for 30
nlnutes.
Treated materials are trans-
ferred fron steriliser to
designated area adjacent to
steriliser (for a 48 hour
quarantine period) using a
lift truck.
Self-contained portable air-
pack is available to opera-
tor for emergency situations.
Steriliser operators are
trained by Quality Control
Department on proper steri-
lisation procedures and
monitoring techniques.
Quality Control Manager and
Plant Sanitarian are li-
censed by state in fuadga-
tion techniques.
Sterilizer is aooitored
daily by operators; aal-
functions are reported in-
wed lately to Bagineering
and Maintenance Departments.
Sterilization charts are
monitored by Quality Control
Department on dally basis
for proper gassing, ster-
ilization time,and chamber
evacuation.
ETO levels were moni-
tored immediately
after opening door and
four minutes after
door opened. Sasples
were collected using
Bendix BDX-44 sai-
ling pimp and charcoal
collection tubes and
analysed on gas chro-
ma tograph (following
MIOSH Procedure S286).
Chafer is monitored
dally to assure com-
pliance with OSHA
standards for occupa-
tional exposure to
ETO.
In response to data
obtained froa moni-
toring, delay of
hour between opening
of chamber door and
unloading charter
was instituted in
procedures.
Booeywell Gas/Vapor
Detector for Freon 12,
equipped with visual
and audible alarm
aystea and located
adjacent to chaaber,
used for continuous
monitoring of gas le-
wis in the workslace.
-------
TABLE C-10 (CONTINUED)
0
1
M
O
Ui
Facility
Sterllieati
on/Fuaigatioa Equipment
Potential
Exposure Situations
Control Measures laplaseated
Size of
Sterilizer
(ft3)
Sterllaot
Used
Cu ImomI
$y«tea
Total
Nuaber of
Operator#®*
Equipment
Design
Workplace
Designa»c
Work
Practices8
Monitoring of
Workplace for Residual
Levels of ETO5
Site M
650
12Z ETO
88: Freod9
Vented to
sewer drain
and outside
ataosphere.
1-4
Access to sterilizer
and aeration area is
not restricted to
steriliser operators;
however, sterilizer
located in an area
vhere there is a
"¦inlaw" of eaployee
traffic.
Operator aust enter
chaaber to retrieve
treated Materials.
Three air washes.
Door operating
switch is reaote-
controlled.
Sterilizer loca-
ted Id Warehouse
(14* * 28* x 25»)
with aechanlcal
area ventilation
(wall exhaust far
located behind
chaaber continu-
ously draws air
away froa chaabes
and to outside
ataosphere) with
1 air change per
hour.
Direction of air-
flow is towards
ETO area froa
non-ETO area.
At end of cycle, chaaber
door is opened Mechanically
by reaote-control (operator
is not at doorway when
chaaber door is opened).
Treated aaterial is
transferred froa sterilizer
to designated quarantine
area uslag lift truck.
Organic vapor respirators
are provided to operators.
Quality Assurance Manager
instructs operating person-
nel and foreasn In steri-
lization procedures.
Coaplete operating instruc-
tions are posted on chaaber
near control panel.
Plant aalntenance personnel
perform aonthly preventive
Maintenance check of all
aechanlcal cosponents.
ETO levels were moni-
tored isnediately
after opening of
chaaber door. Samples
were collected using
Bendix BDX-44 sampling
puap and charcoal col-
lection tubes and
analyzed on gas chrom-
atograph (following
NIOSB Procedure S286).
Survey of steriliza-
tion operation, equip-
ment and storage areas
was made using
Infrared gas analyzer.
Two aonitorings re-
ported that ETO con-
centrations were in
compliance with OSHA
standards for occu-
pational exposure
to ETO (over an 8 hour
TWA).
In response to data
obtained froa moni-
toring, 15 ainute
post-sterilization air
wash with chaaber door
open was Incorporated
into autoaatic steri-
lization cycle.
Facility reported that
Inclusion of air wash
has "assured" alnlana
-------
IABL8 C-10 (CCBTIWBD)
0
1
M
OH
Facility
St«riliutUM/Pail|fttiM Egiifftnt
toul
Saaber of
Operator^
Potential
lipowrc Sitnitloua
Control Measure* Implemented
Monitoring of
Workplace for Residual
Levels of ETO*
Size of
Sterilizer
Sterileat
Died
Get Kenvil
Systen
Equlpeent
Bealga
Workplace
Desigi^*c
Work
Practiced
Site M
(Concluded)
gas exposure levels,
bat did not provide
additional data.
Honeywell Caa/Vapor
Detector for Freon 12,
equipped with visual
and audible al&ra sys-
tem and located adja-
cent to duui>er, used
for continuous eool-
toring of gas levels
in the workplace.
-------
TABLE C-10 (CONTINUED)
0
1
FaciUty
Sterlllzatlon/Fialgation Equipment
Total
Number of
Operators4*1'
Potential
Exposure Situations'
Control Measures Implemented
Monitoring of
Workplace for Residual
Level# of ETOa
Si*e of
Steriliser
(ft3)
Sterilant
Used
Gas Removal
System
Equipment
Design
tforkplace
De»igna»c
Work
Practices9
Site M
281
12Z EXO
88Z FreonP
Vented to
outside
atmosphere.
1
Operator must enter
chamber for 2-3 min-
utes to retrieve
treated materials.
Two air washes.
Sterilizer loca-
ted in storage
room (60' x 40*
x 15') with me-
chanical area
ventilation
(fans) with air
movements of
1,000 cf*.11
Direction of air-
flow is from non-
ETO area towards
ETD area.
Access to ET0 work area is
restricted to sterilizer
operator.
At end of cycle, chamber
door is opened for 20 min-
utes before unloading
chamber.
Operator wears work gloves
or vinyl disposable gloves.
Operators trained in steri-
lization procedures.
Written procedure manual
available.
Door seal check and over-
all maintenance check are
performed periodically.
Hone
-------
TABLE C-10 (aWTMOTB)
0
1
cr>
oo
Facility
Sterilisati
oo/Fuaigation Equip*oat
Total
Kuaber of
Operators^*
Potential
Exposure Situation*8
Control Measures Implemented
Size of
Sterilizer
(ft3>
Sterilant
Used
6w Removal
System
Equipment
Design
Workplace
Design®*0
Work
Practices3
Monitoring of
Workplace for Residual
Levels of ETC^
Site 0
395
IOOZ ETO
Vented to
sewer drain.
2
Hot available.
Two post-vacuuas.
Automatic shut-
off of ETO injec-
tioD if chafer
pressure is too
high.
Sterilizer loca-
ted in area (30'
x 12* x 22') with
mechanical ares
ventilation with
30 air changes
per hour.
Direction of air-
flow is towards
ETO area froi
noo-ETO area.
Storage (aera-
tion) area -ventei
to outside
ataosphere.
Access to ETO work area is
restricted to two sterilizer
operators.
At end of cycle, chamber doox
is opened for 10 minutes
prior to wloading of
chamber.
Treated aaterials are trans-
ported to storage area for
aeration.
Operators receive intensive
verbal training and written
procedures.
ETO volatilizer and evacu-
ation system are checked
routinely and maintenance is
performed regularly.
Monitoring has been
performed using
portable Linde ETO
analyzer.
Facility reported
that corrective ac-
tions have been taken
in response to data
obtained froa moni-
toring and that ETO
levels have been re-
duced to "veil below"
0SHA standard for
occupational exposure
to ETO.
-------
TABLE C-10 (CONTINUED)
n
\
f—1
ON
v£>
Facility
Sterilization/Fumigation Equipment
Total
Huabei of
Operators*1*
Potential
Exposure Situations3
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETC?
Size of
Sterilizer
(ft3)
Sterilant
Used
Gas Removal
Systea
Equipnent
Design
Workplace
Desigi#,c
Work
Practices3
Site P
249
12Z ETO
88Z FreocJ®
Not reported.
3
Access to steriliser
room is not restric-
ted; however, facil-
ity reports that
access is limited due
to its separation
from other operationa
Workers oust enter
chamber to hook tow
chain to palleted
goods.
Three post-vacuums
Sterilizer loca-
ted in separate
rooa (52 * 6" x
36*6° x 22') with
Mechanical area
ventilation
(rotoclone ex-
haust fan) with
air movements of
6500 cfm.d
Particle respirator worn in
ETO sterilization area.
Operators receive on-the-job
training from a previously
trained operator. Training
audited by Quality Control
and Engineering Departments.
Recorder charts for all
cycles are examined by
Quality Control to determine
if abnormalities have
occurred during treatment
process. Complete records
and recorder charts are
maintained by Manufacturing
Department and filled by
Quality Control Department.
Employee exposure to
ETO monitored fol-
lowing NIOSH analyti-
cal method S286.
Eight hour THA for
sterilizer operator
was recorded at 1.6
ppm. Additional data
were not available.
-------
t*BU c-io (carromro)
0
1
(-'
Nl
o
Sterlllzatlon/Fuelgatioa Equipment
Control Meaaures Implemented
Facility
Slse of
Steriliser
(ft»)
Sterilant
Used
Gas Rwnwl
Systca
Total
Huaber of
Operator***
Potential
Exposure Situations*
Equipment
Design
Workplace
Design^
Work
Practiced
Monitoring of
Workplace for Residual
Levels of ETO*
Sice Q
120
121 no
88Z Freoo®
Vented to
outside
ataospfcere.
1
Sot available.
three f nnt-irnrrw
Sterilizer loca-
ted in warehouse
storage area
(40* x 22' z 27')
with passive
area ventilation.
Access to ETO work area re-
stricted to operator.
Treated Materials are reaoved
from sterilizer by fork truck.
Supervisor instructs operator
according to standard written
operating procedures.
Regular Maintenance on vacuu*
p«ep.
Eaployee exposure to
ETO aoaitored fol-
lowing H10SH analy-
tical Method S286.
Eight hour TUA. for
sterilizer operator
was recorded at 0.29
ppn. Additional data
were not available.
-------
TABLE C-10 (CONTINUED)
o
t
Sterilisation/Fumigation Equipment
Control Measures Implemented
Facility
Size of
Steriliser
(ft»)
Sterilant
Used
Gu Removal
System
Total
Huabei of
Operators^
Potential
Exposure Situation^
Equipsent
Design
Workplace
De«igna»c
Work
Practices4
Monitoring of
Workplace for Residual
Levels of EHJ8
Sice K.
1*00®
100Z ETO
Vented to
sever drain.
2
Fork truck (and oper-
ator) Hist enter
chaaber to reaove
treated aeterials.
Three air purges.
Chafer area aea-
sures 40' x 30* i
24* and has me-
i area
ventilation with
air aoveaents of
5,000 cfa.<*
Direction of air-
flow ia froa non-
ETO area to ETO
work area.
Exhaust vent lo-
cated above
chaaber.
Alara aooitoriag
system; addi-
tional data not
provided.
Access to ETO work area is
restricted to ETO ftad.gation
workers.
At completion of cycle,
chaaber door is opened for
10 ainutes before chafer
is mloaded.
Treated materials transferred
froa steriliser to open aera-
tion area using fork truck.
Operators wear respirators
when opening chaaber door.
Operators undergo formalized
training program using
posted procedures.
Maintenance Department
inspects chafer weekly.
Monitoring has been
perforaed. Additions!
data were not
available.
-------
TABLE C-10 (COHTDTOED)
0
1
f—1
ro
Sterilisation/Fumigation Equipment
Control Measures lapleaented
Facility
Size of
Steriliser
(ft3)
Sterilant
Used
Gas Reaovjil
System
Total
Number of
Operator®*"1
Potential
Exposure Situations®
Equipment
Design
Workplace
De8tgna,c
Work
Practices3
Monitoring of
Workplace for Residual
Levels of ETC^
Site S
1600®
1002 ETO
Vented to
sewer and
outside
atmosphere.
2
Mot available.
Three air purges.
Interlocks.
Chaaber room Mea-
sures 40* x 30* x
20* ami has Mech-
anical area
ventilation with
air movements of
5,000 cfm.d
Direction of air-
flow is from noo-
ET0 area to ETO
area.
Alarm aonit.oring
systea; addi-
tional data not
provided.
Exhaust vent lo-
cated above
chafer.
Dislocated con-
trols; additions]
data not
available.
Access to ETO chaaber area is
restricted authorized
personnel.
At coapletion of cycle,
chaaber door is opened for
10 minutes before chaaber
is unloaded.
Cables used to drag pallets
to front of sterilizer;
pallets are then transferred
to open aeration area using
forklift.
Operators wear respirators
when chaaber door opened.
Operators vaidergo formalized
training program using
posted procedures.
Maintenance personnel in-
spect chaaber weekly.
Monitoring has been
performed. Addi-
tional data were not
available.
-------
TABLE C-10 (OOHTDDBD)
0
1
M
U>
FacUity
Sterilization/Fumigation Equipment
¦Potential
Exposure Situations*
Control Measures Implemented
Monitoring of
Workplace for Residual
Levels of ETOa
Size of
Sterilizer
(ft3)
Sterilaac
Used
Gas Removal
Syste*
Total
Number of
Operators*,!
EquLpawaC
Design
Workplace
DMlgn*'0
Work
Practices*
Site T
1100e
1001 ETO
Vented to sever
drain and
to outside
atmosphere.
2
Not available.
Three air purges
Interlocks.
Chamber area mea-
sures 40' x 30* x
18* and has pas-
sive area venti-
lation (outside).
Direction of air-
flow is from noo-
ETO area to ETO
area.
Alarm monitoring
system; addi-
tional data not
provided.
Exhaust vent
located above
chamber.
Dislocated con-
trols; additional
data not
available.
Access to ETO vork area
restricted to authorized
personnel.
At completion of cycle, chaft-
ber door is opened for 10
alnutes prior to unloading of
chamber.
Cables used to drag pallets
to front of sterilizer; pal-
lets are transferred to open
aeration area using forklift.
Operators wear respirators
when chamber door is opened.
Goggles and gloves are avail-
able for use at discretion of
operator.
Operators undergo formalized
training program using posted
procedures.
Maintenance personnel inspect
chambeT weekly.
Monitoring has been
performed. Additional
data were not
available.
-------
TAftl K C-10 (OOBIIIDBD)
0
1
t-1
JN
Sterilisation/Fumigation Equipment
Control Measures Implemented
Facility
Site of
Steriliser
(ft3)
Sterilant
Used
Gu Removal
System
Total
Hurter of
Operator®**
Potential
Exposure Situations*
Equipment
Design
Workplace
ScslgBV
Work
Practices3
Monitoring of
Workplace for Residual
Levels of ETO*
Site U
(2)750
1320
1001 ETQ
Vented to
sewer drain.
2
Hot available.
One post-vacuum.
Chamber room (42'
* 32' * 10*)
equipped with
¦echanical area
ventilation with
4 air changes per
iour.
Direction of air-
flow is from noC»-
B10 w>rk areas to
ETO work area.
Exhaust system In
storage (aeration)
area.
Access to ETO fumigation area
is restricted to authorized
personnel.
At completion of cycle, cham-
ber door Is partially opened
for 30 minutes before chamber
is unloaded.
Pallets in rear of chamber
pulled forward using tow bar.
Treated materials are trans-
ferred from charter room to
storage area using a fork
truck.
Operators wear partial face
respirators during removal
of pallets from charter if
entry into chamber is
required.
Operators trained by depart-
ment supervisor using written
procedures document during
on-the-job instruction
(covering safety and steri-
lization procedures). Super-
visor makes final check of
system before every steri-
lization cycle.
Equipment inspected monthly
by company in accordance with
written plant procedure. In
addition, company's insurance
carrier inspects equipment 4
times annually.
Chamber room and
aeration area moni-
tored using WiIks-
Mi ran 101 analyser.
First aonitoring test
were performed using
Linde Atmospheric
Monitor.
In response to data
obtained from moni-
toring, ventilation
was increased, 30
minute delay between
opening and unloading
of chamber was insti-
tuted, and use of
respirator if worker
must enter chamber
was required.
Facility reported
that changes did de-
crease ETO levels in
plant and that em-
ployee exposure to
ETO (as an 8 hour
TWA) has been re-
corded at 12.6 ppm
and 17.4 ppm.
-------
TABLE C-10 (CONCLUDED)
^ata in this column apply to all ETO sterilizers, sterilizer operators, or ETO work areas at
this facility.
^Refers to the total number of persons authorized to operate ETO sterilization equipment at
this facility.
°Where indicated, the dimensions of ETO work areas represent length x width x height,
defers to cubic feet per minute.
eSize of sterilizer is measured in square feet (ft2).
-------
TABLE C-ll
PRACTICES RELATIVE TO WORKER EXPOSURE AT
COSMETICS XHDUSTKY SITES4
0
1
ON
Facility/
Location
Sterillsation/Pualgatlou Equipment
Size of
Sterilizer
(ft3>
Sterilant
0i«4b
Gu ReaovaL
Systsab
Total
Number of
Operatorsc
Potential
Exposure Situations'5
Control Measures Implemented
Equipment
Design*1
Workplace
Designb,d
Work
Practices11
Monicoriog of
Workplace for Residual
Levels of ETO*5
4icro-Biotrol
Bound Brook.
KJ.
Chicago,
IL.
Levittown,
PA.
Los Angeles,
CA.
Sayrna,
CA.
258
275
442
509
659
662
663
259
(3) 280
360
(2) 660
66*
(3) 660
259
(2) 260
638
664
717
736
(3) 436
443
Via vacuum
pumps to water
separator and
thence to sewei
Separator also
vented through
roof stack'
11
Operators oust enter
chamber to retrieve
treated aaterlals.
One or more post-
vacuuas drawn to
evacuate ET0 froa
free space of
chaaber. One
vacuus is typi-
cally employed;
however, a second
full vacuus is
drawn prior to
opening of chamber
if one hour or
aore has elapsed
since conclusion
of cycle.
Circulation syste
to facilitate even
distribution of
heated ETO/alr
gas mixture
throughout chaa-
ber (particularly
In rear of chaaber
where air circula-
tion aay normally
be limited) is
built into chaa-
ber and operated
during unloading.
Mechanical area
ventilation
(fans).
Direction of air-
flow Is towards
ETO area from
non-ETO area.
Fans located
above chambers
which direct air-
flow away froa
worker and
facilitate dis-
persion of ETO
once it has
escaped froa
chamber.
Storage room
(ventilation/
areatlon area)
equipped with
air circulation
systems in which
fresh air is in-
troduced at ceil-
ing level and
vented at floor
level.
Access to ETO sterilization
area restricted to authorized
personnel.
At end of cycle operators
loosen hand wheels on chaaber
door; There is a tlae delay
of at least five ninutes
while operator brings over
end puts in place raap,
readies identification stasp,
and then stamps stickers with
lot nuaber.
Materials are removed from
chamber by using construc-
tion battery powered trans-
ports or hand pallet mover.
Pallets are then stored in
specially designated ware-
bouse area.
Operators spend 8 hours per
shift on ETO gas treatment
and are responsible for gas
processing of materials.
Three aonth in-house training
prograa for new eaployees on
ETO procedures, including
instruction in hazard identi-
fication and procedures to be
followed in case of asergency
Equipment serviced by la-house
personnel twice annually.
Have Instituted systea of
record-keeping for Inspec-
tion and maintenance.
Monitoring has been
performed using gas
chromatography and
Wilks-Miran 101 Gas
Analyzer. Based on
this aonitoring,
Micro-Biotrol reports
that workers at its
facilities are exposed
to less than 50 ppa as
an 8 hour tlae weighted
average. Additional
data not made
avallable.
-------
TABLE C-ll (CONCLUDED)
^icro-Biotrol, a contract sterilizer, fumigates 80 to 84 percent of the cosmetic raw materials and
100 percent of the hardware items used by the cosmetics industry. In addition to cosmetics,
Micro-Biotrol sterilizes spices, medical products, and dairy packaging products.
^Data in this column applies to each of the five sites listed.
cRefers to the total number of persons authorized to operate ETO sterilization/fumigation equip-
ment at this facility.
^The dimensions (length x width x height) of the ETO work area and the rate of air exchanges or
movements at the five Micro-Biotrol facilities are:
Bound Brook: 87' x 45' x 21', 5000 cubic feet per minute (cfm);
Chicago: 70' x 32' x 11V and 52' x 28' x 13', 6500 cfm in 70' long room and 3000 cfm in 52'
long room
Levittown: 40' x 40' x 20', 3500 cfm;
Los Angeles: 78V x 51^' x 20', 9 air changes per hour;
Smyrna: 38' x 27' x 28', 3500 cfm.
SOURCE: Alguire, 1979; 1980; Yeung, 1980.
-------
. / ,v ^ / ) "/
):
Department Approval
MITRE Project Approval:.
------- |