Standard Operating Procedure for Monitoring Environmental Parameters of Incubators, Refrigerators, Freezers, Laboratories and Sample Storage Rooms SOP Number: QC-05-10


US Environmental Protection Agency
Office of Pesticide Programs
Office of Pesticide Programs
Mic ro bio lo gy La bo ra to ry
Environmental Science Center, Ft. Meade, MD
Standard Operating Procedure for
Monitoring Environmental Parameters of Incubators,
Refrigerators, Freezers, Laboratories and Sample
Storage Rooms
SOP Number: QC-05-10
Date Revised: 10-23-18

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SOP No. QC-05-10
Date Revised 10-23-18
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SOP Number
SOP Number: QC-05-10
Title
Monitoring Environmental Parameters of Incubators, Refrigerators,
Freezers, Laboratories and Sample Storage Rooms
Scope
Describes the operation and maintenance of the Environmental
Monitoring and Alarm System (EMAS) which is a computer-based
system designed to collect environmental data electronically for
incubators, refrigerators, freezers, laboratories and sample storage
rooms. Data are collected through a network of wireless
environmental monitoring devices that use radio frequency to
transmit and receive data about current environmental conditions.
Application
Describes how to archive data generated by the EMAS and the
procedure for the manual collection and recording of environmental
data in the event that the EMAS is malfunctioning.


Approval Date
SOP Developer:

Print Name:
SOP Reviewer

Print Name:
Quality Assurance Unit

Print Name:
Branch Chief

Print Name:
Date SOP issued:

Controlled copy
number:

Date SOP withdrawn:

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SOP No. QC-05-10
Date Revised 10-23-18
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TABLE OF CONTENTS
Contents	Page Number
1.
DEFINITIONS
3
2.
HEALTH AND SAFETY
3
3.
PERSONNEL QUALIFICATIONS AND TRAINING
3
4.
INSTRUMENT CALIBRATION
3
5.
SAMPLE HANDLING AND STORAGE
4
6.
QUALITY CONTROL
4
7.
INTERFERENCES
4
8. NON-CONFORMING DATA
4
9.
DATA MANAGEMENT
5
10.
CAUTIONS
5
11.
SPECIAL APPARATUS AND MATERIALS
5
12.
PROCEDURE AND ANALYSIS
6
13.
DATA ANALYSIS/CALCULATIONS
7
14.
FORMS AND DATA SHEETS
7
15.
REFERENCES
7

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SOP No. QC-05-10
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1. Definitions
1.	ASTM = American Society for Testing and Materials
2.	ISO 17025 = The main standard used by testing and calibration
laboratories, and issued by the International Organization for
Standardization (ISO). ISO 17025 is used to implement a quality
system aimed at improving the ability of a lab to consistently
produce valid results.
3.	Input # = EMAS number designation for probe which collects
environmental data.
5.	Unit # = Microbiology Laboratory Branch (MLB) number
designation for each piece of equipment (incubator, refrigerator or
freezer) for which environmental data are collected.
6.	Target Temperature = Temperature prescribed in Microbiology
Laboratory SOPs or research protocols for incubators, refrigerators,
freezers, laboratories and sample storage rooms.
7.	Period-End Alarm Limits = Exclusive range of environmental
measurement limits (e. g., temperatures, percent humidity, percent
CO2, etc.) which are set programmatically in the EMAS system
which define whether a probe is within the normal (acceptable)
range. If a probe is outside the normal range, it is in alarm status.
2. Health and
Safety
Not applicable
3. Personnel
Qualifications
and Training
1.	Lab personnel should be familiar with the operation of the EMAS.
Lab personnel should be knowledgeable about printing and reading
the EMAS Specified Period Averages Report (Highs, Lows, and
Averages Report for a specified time period, see example in
Attachment 1).
2.	Selected lab personnel are authorized to manage and retrieve data
for the EMAS.
4. Instrument
Calibration
1.	A reputable vendor calibrates the EMAS sensors yearly against ISO
17025 accredited instruments via service contract. The correction
factors for each sensor are entered into the system by the vendor's
technical staff. The calibration certificates are kept on file in room
B209 with the most recent Rees Calibration Protocol Report
notebook for the EMAS instruments.
2.	See SOP EQ-02, Calibration of Thermometers, for calibration and
accuracy point check requirements for thermometers specified in
section 11.4. Use these thermometers temporarily to monitor
temperatures when the EMAS system is not functioning properly

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SOP No. QC-05-10
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(see section 12.5). Use only units which have been calibrated or
point checked as per SOP EQ-02.
5. Sample
Handling and
Storage
Not applicable
6. Quality Control
1.	For quality control purposes, document the required information on
the appropriate forms.
2.	Maintain thermometer calibration certificates and point check
calibration records in a notebook and archive it in the laboratory's
file room D217.
7. Interferences
When an EMAS sensor or the entire EMAS is not functioning,
follow the procedures listed in Section 12.5.
8. Non-
conforming
Data
1.	Document any deviation from the standard procedures in the
Environmental Monitoring and Alarm System Incident Log (see
section 14) and investigate it. Determine the reasons for any
difficulties achieving and maintaining the target temperature. Note
the appropriate corrective action taken by the laboratory staff. If the
problem cannot be determined or corrected, call in a service
technician to evaluate the situation and to initiate the service on the
equipment.
2.	If the temperature or humidity of the sample storage room or area is
not within the target temperature or humidity range, contact building
authorities to initiate adjustments/repairs to the air supply system.
3.	If the temperature or humidity of the sample storage room or area
deviates significantly from target temperature or humidity ranges
for an extended period, contact the Office of Enforcement and
Compliance Assurance (OECA) for advice on sample
retention/di sposal.
4.	Disaster Recovery Plan: The EMAS monitoring devices use small,
low voltage batteries as back-up power and are unaffected by power
loss. The monitoring devices are supported by repeaters which help
transmit data from the probes back to the EMAS computer which
converts the data into information. The repeaters have a 24 hour
battery backup to prevent data loss in the event of a disaster. The
EMAS computer, which is on the Environmental Science Center's
(ESC) emergency back-up power, has a battery back-up that will
last a minimum of 6 hours and up to 24 hours. When the battery
back-up on the EMAS computer is engaged, a telephone alarm will
be triggered. In addition to the battery back-up, the EMAS daily

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SOP No. QC-05-10
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backs up all data and files needed for the EMAS to function to a
thumb drive plugged into the EMAS computer.
9. Data
Management
1.	File the EMAS Incident Log Form (see section 14) in a notebook
kept by the assigned analyst.
2.	File the Incubator, Refrigerator, Freezer Manual Temperature
Recording Form and Sample Storage Room Manual
Temperature/Humidity Recording Form (see section 14) for manual
recording (when an EMAS or the entire EMAS is not functioning)
in a notebook.
3.	Archive completed report forms, logs and temperature record on a
yearly basis in notebooks kept in secured file cabinets in room
D217. Archived data are subject to OPP's official retention
schedule contained in SOP ADM-03, Records and Archives.
4.	Maintain a list of MLB incubators, refrigerators and freezers
electronically. The list also contains the target temperature and
period-end alarm limits associated with each piece of monitored
equipment. File a hard copy (Attachment 3) of the updated list in the
front of the notebook containing the EMAS Specified Period
Averages Report.
10. Cautions
1.	It is permissible to widen the EMAS alarm ranges for inputs
associated with empty and unused equipment to prevent activation
of an EMAS alarm. This prevents activation of an EMAS alarm
when unused equipment is out of range.
2.	The alarm for laboratory room temperature and humidity sensors
(not including sample storage rooms) may be inhibited for a night,
weekend or other non-work day (holiday, snow day, etc.) because
recording temperature of these areas during non-work hours is not
critical.
11. Special
Apparatus and
Materials
1.	The EMAS is a computer-based system which monitors several
types of inputs, analyzes for outputs outside the established
acceptable range and ensures that the appropriate lab staff members
are notified by telephone when the measured parameter is outside of
its acceptable range. The EMAS is loaded on a stand-alone
computer (EMAS Computer) in Room B209 and is password
protected. The system is on the building's backup power system
and also has a six hour battery backup.
2.	The EMAS probes are placed in incubators, refrigerators, freezers,
laboratories and sample storage rooms managed by the
Microbiology Laboratory Branch with the exception of room D122.

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3.	See Attachment 3 for a list of monitored equipment and associated
target temperatures and period-end alarm limits.
4.	In the event when the EM AS or a sensor is not working:
a.	Use thermometers (see SOP EQ-02, Calibration of
Thermometers) to monitor temperatures of individual
incubators, refrigerators and freezers.
b.	Use humidity/temperature meters to monitor temperature and
humidity of rooms.
12. Procedure and
Analysis
1.	Print the EMAS Specified Period Averages Report (Highs, Lows, and
Averages Report for a specified time period; see example in
Attachment 1) for each calendar day. This report reflects the status of
the system from 8:00 a.m. of the previous day to 8:00 a.m. of the
current day.
a.	For weekends, holidays and days when the ESC is closed for any
reason, print the EMAS Specified Period Averages Report on the
next working day for each 24 hour period starting at 8:00 a.m.
and ending at 8:00 a.m. the next day.
b.	Print the Input Reading Graphs for a specific input for a current
day if there is a need to look at real-time data due to the critical
nature of a study. A report printed in this situation does not need
to be filed.
2.	To print the report, check the box marked "ALL AVG" for the
"Highs, Lows, and Averages Report." The report option window will
appear. Select "Average Over Specified Time Period," fill in date and
time, click "OK" and print the report (e.g., print two pages/sheet).
3.	Review the report, focusing on the Specified Period Averages Report
for laboratory inputs. See Attachments 1 and 3.
a. Any lows or highs underlined in the report were outside of the
alarm limits for more than four hours. Refer to the Input Reading
Graphs for the underlined input. If a value was outside of an
alarm limit for more than four hours for incubators, refrigerators
and freezers, note the occurrence in the Environmental
Monitoring and Alarm System Incident Log Form (see section
14), as well as any corrective action taken (temperature of unit
adjusted, door closed tightly, etc.). Initial, date, and file the
report.
4.	When an analyst is contacted by telephone that an input is out of
period-end alarm limit range, follow the instructions in Attachment 2

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SOP No. QC-05-10
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(EMAS: Instructions for Telephoned Alarms) to inhibit or reset the
input.
5. When an EMAS input or the entire EMAS is not functioning,
manually record the temperature of the affected instruments by
reading either thermometers or the humidity/temperature meters once
daily each working day, excluding holidays and days when the ESC is
closed for any reason.
a.	Record the data on the appropriate Incubator/Refrigerator/
Freezer Manual Temperature Recording Form (see section 14) or
Sample Storage Room Manual Temperature/Humidity Recording
Form (see section 14). See Sections 11.4 and 4.2.
b.	On weekends, holidays and days when the ESC is closed, note
the reason why the temperature was not recorded under
"Maintenance and Notes" on the form.
13. Data Analysis/
Calculations
None
14. Forms and Data
Sheets
1.	Attachment 1: Example of EMAS Specified Period Averages Report
2.	Attachment 2: EMAS: Instructions for Telephoned Alarms
3.	Attachment 3: List of MLB Incubators, Refrigerators, Freezers and
Sample Storage Rooms Covered by EMAS
4.	Test Sheets. Test sheets are stored separately from the SOP under the
following file names:
Environmental Monitoring and Alarm System QC-05-10 Fl.docx
Incident Log Form
Incubator/Refrigerator/Freezer Manual QC-05-10 F2.docx
Temperature Recording Form
Sample Storage Room Manual QC-05-10_F3.docx
Temperature/Humidity Recording Form
15. References
1.	Rees Scientific Centron Environmental Control and Monitoring
System User Manual located in room B209.
2.	Rees Scientific Centron Environmental Control and Monitoring
System Validation Protocol located in room B209.
3.	Rees Scientific Monitoring Instrumentation Access Control in room
B209.

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