US Environmental Protection Agency
Office of Pesticide Programs
Office of Pesticide Programs
Microbiology Laboratory
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-05-06
Date Revised: 07-06-11
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 1 of 12
EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD
Standard Operating Procedure
for
Monitoring Environmental Parameters of Incubators, Refrigerators, Freezers, Laboratories and
Sample Storage Rooms
SOP Number: QC-05-06
Date Revised: 07-06-11
Initiated By:
Technical Review:
QA Review:
Approved By:
Print Name:
Print Name:
Technical Staff
Print Name:
QA Officer
Print Name:
Branch Chief
Date:
Date:
Date: / /
Date: / /
Effective Date:
Controlled Copy No.
Withdrawn By:
Date:
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 2 of 12
TABLE OF CONTENTS
Contents
Page Number
1.0 SCOPE AND APPLICATION 3
2.0 DEFINITIONS 3
3.0 HEALTH AND SAFETY 4
4.0 CAUTIONS 4
5.0 INTERFERENCES 4
6.0 PERSONNEL QUALIFICATIONS 4
7.0 SPECIAL APPARATUS AND MATERIALS 4
8.0 INSTRUMENT OR METHOD CALIBRATION 5
9.0 SAMPLE HANDLING AND STORAGE 6
10.0 PROCEDURE AND ANALYSIS 6
11.0 DATA ANALYSIS/CALCULATIONS 7
12.0 DATA MANAGEMENT/RECORDS MANAGEMENT 7
13.0 QUALITY CONTROL 7
14.0 NONCONFORMANCE AND CORRECTIVE ACTION 8
15.0 REFERENCES 9
16.0 FORMS AND DATA SHEETS 9
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 3 of 12
1.0 SCOPE AND APPLICATION:
1.1 This SOP 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.
1.2 This SOP describes how to archive data generated by the EMAS.
1.3 This SOP also describes the procedure for the manual collection and recording of
environmental data in the event that the EMAS is malfunctioning.
2.0 DEFINITIONS:
2.1 ASTM = American Society for Testing and Materials
2.2 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.
2.3 ISO 17025 Acredited Verification Thermometer = A thermometer/hygrometer
that has been calibrated by a recognized ISO 17025 accredited vendor.
Calibration certificate must have stamp of accrediting body (e.g., A2LA) and
calibration vendor certificate number.
2.4 Input # = EMAS number designation for probe which collects environmental
data.
2.5 Unit # = Microbiology Laboratory Branch (MLB) number designation for each
piece of equipment (incubator, refrigerator or freezer) for which environmental
data are collected.
2.6 Target Temperature = Temperature prescribed in Microbiology Laboratory SOPs
or research protocols for incubators, refrigerators, freezers, laboratories and
sample storage rooms.
2.7 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
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 4 of 12
normal (acceptable) range. If a probe is outside the normal range, it is in alarm
status.
2.8 ESC = Environmental Science Center.
3.0 HEALTH AND SAFETY: Not applicable
4.0 CAUTIONS:
4.1 If an incubator, refrigerator or freezer is known to be empty or not used regularly,
the EMAS alarm may be inhibited or designated as "not in use".
4.2 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) since recording temperature of these areas during
non-work hours is not critical.
5.0 INTERFERENCES:
5.1 When an EMAS sensor or the entire EMAS is not functioning, follow the
procedures listed in Section 10.5.
6.0 PERSONNEL QUALIFICATIONS:
6.1 Lab personnel need to be familiar with the operation of the EMAS. Most
importantly, 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).
6.2 Selected lab personnel will be authorized to manage and retrieve data.
7.0 SPECIAL APPARATUS AND MATERIALS:
7.1 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.
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 5 of 12
7.2 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.
7.3 Incubators: The target temperature is consistent with the work being performed
and is set as follows:
• set temperature 30 ± 1°C with alarm limits between 28.9°C and
31.1°C;
• set temperature 36 ± 1°C with alarm limits between 34.9°C and
37.1°C;
• set temperature 42 ± 1°C with alarm limits between 40.9°C and
43.1°C;and
• set temperature between 55 ± 1°C with alarm limits between 53.9°C
and56.1°C.
7.4 Refrigerators: The target temperature will be between 2°C and 5°C with alarm
limits between 1°C and 6°C.
7.5 Freezers: The target temperatures and alarm limits are consistent with the work
being performed and are set as follows:
• set temperature between -20°C and -10°C;
• set temperature between -25°C and -15°C; and
• set temperature between -85°C and -75°C.
7.6 Laboratories and Sample Storage Rooms: The target temperatures will be
between 15°C and 25°C with alarm limits below 14°C and above 26°C, and the
target humidity will be the standard humidity ranges for this facility and alarm
limits will be below 10% and above 75%.
7.7 In the event when the EMAS or a sensor is not working:
7.7.1 Thermometers (see SOP EQ-02, Calibration of Thermometers) are used to
monitor temperatures of individual incubators, refrigerators and freezers.
7.7.2 Humidity/temperature meters are used to monitor temperature and
humidity of rooms.
8.0 INSTRUMENT OR METHOD CALIBRATION:
8.1 The EMAS sensors are calibrated yearly against ISO 17025 accredited
instruments through a service contract with a reputable vendor. The calibration
certificates are kept on file in room B209 with the most recent Rees Calibration
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 6 of 12
Protocol Report notebook for the EMAS instruments.
8.2 The accuracy point check of the thermometers specified in Section 7.7.1 is
performed according to SOP EQ-02, Calibration of Thermometers, when needed.
8.3 The ISO 17025 accredited verification thermometers and temperature/humidity
meters are calibrated annually by an ISO 17025 accredited vendor laboratory.
9.0 SAMPLE HANDLING AND STORAGE: Not applicable
10.0 PROCEDURE AND ANALYSIS:
10.1 The EMAS Specified Period Averages Report (Highs, Lows, and Averages
Report for a specified time period, see example in Attachment 1) will be printed
for each calendar day. This report will reflect the status of the system from 8:00
a.m. of the previous day to 8:00 a.m. of the current day. For weekends, holidays
and days when the ESC is closed for any reason, the EMAS Specified Period
Averages Report will be printed 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. The Input Reading
Graphs may also be printed 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.
10.2 Assigned analysts will review the report, focusing on the Specified Period
Averages Report for inputs 1 through 90 (some of the inputs in between are either
currently "not in use" or discontinued). Any lows and highs which are underlined
are outside of the period-end alarm limits and will be noted in the Environmental
Monitoring and Alarm System Incident Log Form (Form 16.1) and the corrective
action taken (temperature of unit adjusted, door closed tightly, etc.). The report
should be initialed and dated and filed in a notebook in B209.
10.3 When an analyst is contacted by telephone that a sensor is out of period-end alarm
limit range, follow the instructions in Attachment 2 (EMAS: Instructions for
Telephoned Alarms) to inhibit or reset the probe.
10.4 A notation of significant incidents involving temperatures or humidity being out
of range or problems with the EMAS will be entered into the Environmental
Monitoring and Alarm System Incident Log (Form 16.1) which is kept in a
notebook in B209. The analyst will enter the EMAS input number, unit number,
room number, incident description, action taken, and initial and date the entry.
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 7 of 12
10.5 When an EMAS sensor or the entire EMAS is not functioning, the temperature of
the affected instruments will be recorded manually 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 and recording
the data on the appropriate Incubator/Refrigerator/Freezer Manual Temperature
Recording Form (Form 16.2) or Sample Storage Room Manual
Temperature/Humidity Recording Form (Form 16.3). See Sections 7.7.1 and 8.2.
On weekends, holidays and days when the ESC is closed, the reason may be noted
why the temperature was not recorded under "Maintenance and Notes" on the
form.
11.0 DATA ANALYSIS/CALCULATIONS: None
12.0 DATA MANAGEMENT/RECORDS MANAGEMENT:
12.1 The EMAS Specified Period Averages Report will be printed on a daily basis. For
weekends, holidays and days when the ESC is closed for any reason, the report
should be printed on the next working day for each calendar day, one report per
calendar day. The reports are filed in a notebook in room B209.
12.2 The EMAS Incident Log (see Form 16.1) is kept in a notebook in room B209.
12.3 The Incubator, Refrigerator, Freezer Manual Temperature Recording Form and
Sample Storage Room Manual Temperature/Humidity Recording Form (Forms
16.2 and 16.3) for manual recording (when an EMAS or the entire EMAS is not
functioning) are kept in room B209.
12.4 Completed report forms, logs and temperature record forms are archived 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.
12.5 A list of MLB incubators, refrigerators and freezers will be maintained
electronically using a Microsoft Word table. A hard copy (Attachment 3) of the
updated list with effective dates will be filed in the front of the notebook
containing the EMAS Specified Period Averages Report.
13.0 QUALITY CONTROL:
13.1 For quality control purposes, the required information is documented on the
appropriate forms.
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 8 of 12
13.2 The EMAS sensors are calibrated yearly against ISO 17025 accredited
instruments through a service contract with a reputable vendor. The correction
factors are entered into the system by the vendor's technical staff for accuracy.
13.3 In the event when the EMAS or a sensor is not working, thermometers, if needed,
are point checked against an ISO 17025 accredited verification thermometer. A
label displaying the correction factor is placed around the top of the
corresponding thermometer. This procedure is described in SOP EQ-02,
Calibration of Thermometers. The point check calibration records of
thermometers are maintained in a notebook, which is archived in the laboratory's
file room D217.
13.4 The ISO 17025 accredited verification thermometers and temperature/humidity
meters are calibrated annually by an ISO 17025 accredited company. The current
calibration certificates for the ISO 17025 accredited verification thermometers are
maintained with the most recent Rees Calibration Protocol Report notebook in
room B209.
14.0 NONCONFORMANCE AND CORRECTIVE ACTION:
14.1 Any deviation from the standard procedures will be documented in the
Environmental Monitoring and Alarm System Incident Log (Form 16.1) and
investigated. The reasons for any difficulties achieving and maintaining the target
temperature will be determined and the appropriate corrective action will be taken
by the laboratory staff. If the problem cannot be determined or corrected, a
service technician will be called in to evaluate the situation and to initiate the
service on the equipment.
14.2 If the temperature or humidity of the sample storage room or area is not within the
target temperature or humidity range, building authorities will be contacted to
initiate adjustments/repairs to the air supply system.
14.3 If the temperature or humidity of the sample storage room or area deviates
significantly from target temperature or humidity ranges for an extended period,
Office of Enforcement and Compliance Assurance (OECA) may be contacted for
advice on sample retention/disposal.
14.4 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
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 9 of 12
EMAS computer, which is on the 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 backs up all data and files
needed for the EMAS to function to a thumb drive plugged into the EMAS
computer.
15.0 REFERENCES:
15.1 Rees Scientific Centron Environmental Control and Monitoring System User
Manual located in room B209.
15.2 Rees Scientific Centron Environmental Control and Monitoring System
Validation Protocol located in room B209.
15.3 Rees Scientific Monitoring Instrumentation Access Control located in room B209.
16.0 FORMS AND DATA SHEETS:
16.1 Environmental Monitoring and Alarm System Incident Log Form
16.2 Incubator/ Refrigerator/ Freezer Manual Temperature Recording Form
16.3 Sample Storage Room Manual Temperature/Humidity Recording Form
ATTACHMENTS
Attachment 1: Example of EMAS Specified Period Averages Report
Attachment 2: EMAS: Instructions for Telephoned Alarms
Attachment 3: List of MLB Incubators, Refrigerators, Freezers and Sample Storage
Rooms Covered by EMAS
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 10 of 12
16.1 Environmental Monitoring and Alarm System Incident Log Form
Year Page
Date and
Initials
EMAS
Input
No.
Unit
No.
Room
No.
Incident Description
Action Taken
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 11 of 12
16.2 Incubator/Refrigerator/Freezer Manual Temperature Recording Form
OPP Microbiology Laboratory
Month /Year: /
Acceptable Temp. Range:
Day
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Time/ Init.
Temp.*
Laboratory #/inc., ref., or frez I
Thermometer ID / Correction F
Adjustments Necessary
y. i
actor: / °C
Maintenance and Notes
* Corrected temperature recorded
-------
SOP No.QC-05-06
Date Revised 07-06-11
Page 12 of 12
16.3 Sample Storage Room Manual Temperature/Humidity Recording Form
OPP Microbiology Laboratory
Month /Year: / Target Temperature:
Room No
Day
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
: Thermometer ID/Correction Factor: / °C
Time/Initials
Temperature
Humidity
Notes /Comments
-------
Attachment 2: EMAS: Instructions for Telephoned Alarms
OPP Microbiology Laboratory
Rees Scientific Centron Alarm
Instructions for Telephoned alarms
IMPORTANT - Press the Phone's Buttons Slowly.
Node Telephone Number: ^/"/D ~~
-------
Attachment 2 (con't): EMAS: Instructions for Telephoned Alarms
OPP Microbiology Laboratory
"To inhibit input "X", enter number "X"then"#", "X" = Number of Hours, Use the"*" as
of hours followed by the "#"sign. a decimal point if you need it (i.e. 2 V*
Use the "*" key for the decimal point." hours = 2*5#),
Rees Scientific Centron Alarm
Instructions for Telephoned alarms (Continued)
What your hear What you Do What it means
"Input "X" has been inhibited Listen, Confirms the entered probe number and
for ? Hours." number of hours it is turned off.
"Press "1" to check global status, Press "S" then "#" or choose
"2" to check single input status. '3" another option.
to inhibit an input, "4" to enable an
input, "5" to hang up."
The Message will repeat itself. If more than one probe is in alarm, you would take care of them one at a time.
BASIC TIPS
1. Press the Telephone's buttons SLOVVLEY.
2. Don't give out your pass code to anyone. With your code other people are able to make changes to the
system (at your security level). That will make it look like you did it.
3. Utilizing telephone option number 1 or 2, you can call back into the system at a later time and check on the
real-time status of the probe you inhibited (or any probe for that matter). This way you can see if it is still
moving further out of range or coming back into range, (Use the Nodes telephone number on front page)
4. Always report any telephone activity with the Centron system to your supervisor. Documentation needs to be
maintained on any interaction with the system, (i.e. the why of what you did.) The system records the who,
what, and when of any interaction.
5. Notify your supervisor of any changes to your telephone number.
6. Know which probe number refers to which piece of equipment. Write the equipment you are responsible for
with the probe number below.
Created on 12/4/02 Page 2 of 2
-------
Attachment 3: List of MLB Incubators, Refrigerators, Freezers and Sample
Storage Rooms Covered by EMAS
OPP Microbiology Laboratory
MLB Incubator, Refrigerator and Freezer Inventory
Effective / / to / /
Input
No.
Unit
No.
Location
(Room)
Manufacturer
Model No.
Serial No.
Target Temp.
Period-End
Alarm Limits
Incubators
5
8
9
13
14
21
22
26
37
38
81
181
191
271
281
261
251
91
201
211
B209
B202
B202
B201
B201
B204
B204
B209
B207
B207
Boekel
VWR
VWR
Thermo Scientific
Thermo Scientific
Yamato
Yamato
Lab-Line
VWR
VWR
132000
3025T
3025B
3110
3110
IC800
IC800
Imperial III
3025T
3025B
06046
08105206
08105206
310829-31776
310829-31775
IC801B6Z00234
IC801B6300002
0799-0160
08105106
08105106
55°C±1°C
36°C±1°C
36°C±1°C
36°C±1°C
36°C±1°C
36°C±1°C
36°C±1°C
42°C ± 1°C
36°C±1°C
36°C±1°C
53.9°Cto
56.1°C
34.9°C to
37.1°C
34.9°C to
37.1°C
34.9°C to
37.1°C
34.9°C to
37.1°C
34.9°C to
37.1°C
34.9°C to
37.1°C
40.9°C to
43.1°C
34.9°C to
37.1°C
34.9°C to
37.1°C
Refrigerators
4
7
20
28
29
32
40
41
11R
8R
12R
5R
3R
2R
6R
1R
B202
B209
B204
B205
B201
B206
B207
B207
Fisher
Revco
Thermo Electron
Summit
Westinghouse
Westinghouse
Summit
Summit
Isotemp Plus
RFS214A14
REC4504A21
BI-605J
WRT17CGAWO
WRT17CGAWO
BI-605J
BI-605J
410N0005
R02L-52413-RL
X06R-125660-XR
970900676
BA32403117
BA32603844
970900665
970900695
2°C to 5°C
2°C to 5°C
2°C to 5°C
2°C to 5°C
2°C to 5°C
2°C to 5°C
2°C to 5°C
2°C to 5°C
°C to 6°C
°C to 6°C
°C to 6°C
°C to 6°C
°C to 6°C
°C to 6°C
°C to 6°C
°C to 6°C
Freezers
17
30
33
44
10F
3F
2F
9F
B209
B201
B206
B209
Revco
Westinghouse
Westinghouse
Revco
ULT1740-3-A36
WRT17CGAWO
WRT17CGAWO
ULT390-5-A30
U07N-200015-UN
BA32403117
BA32603844
U08J-443679-UJ
-25°Cto-15°C
-20°Cto-10°C
-20°Cto-10°C
-85°C to -75°C
-25°Cto-15°C
-20°Cto-10°C
-20°Cto-10°C
-85°C to -75°C
Sample Storage Rooms for Temperature and Humidity
1
D204
NA
NA
NA
20°C ± 5°C
14°C to 26°C
-------
Input
No.
2
18
19
Unit
No.
Location
(Room)
D204
B204
B204
Manufacturer
NA
NA
NA
Model No.
NA
NA
NA
Serial No.
NA
NA
NA
Target Temp.
Not Specified
20°C ± 5°C
Not Specified
Period-End
Alarm Limits
10% to 75%
14°C to 26°C
10% to 75%
Incubators for Temperature and Humidity
79
80
81
82
83
84
85
86
11
11
241
241
221
221
231
231
B204
B204
D204
D204
B202
B202
B207
B207
Precision
Precision
Yamato
Yamato
Yamato
Yamato
Yamato
Yamato
30M
30M
IC800
IC800
IC800
IC800
IC800
IC800
699010761
699010761
IC801B6300004
IC801B6300004
IC801B6300003
IC801B6300003
IC801B6300001
IC801B6300001
Not Specified
36°C±1°C
Not Specified
36°C±1°C
Not Specified
36°C±1°C
Not Specified
36°C±1°C
10% to 75%
34.9°C to
37.1°C
10% to 75%
34.9°C to
37.1°C
10% to 75%
34.9°C to
37.1°C
10% to 75%
34.9°C to
37.1°C
------- |