EPA/OPP MICROBIOLOGY LABORATORY ESC, Ft.

Meade, MD Standard Operating Procedure for Monitoring Temperature of Incubators, Refrigerators, and Freezers SOP Number: QC-05-03 Date Revised: 06-28-05

Prepared By: Print Name:

Date: ___/___/___

Reviewed By: Print Name: Technical Staff

Date: ___/___/___

Date: ___/___/___ Print Name: QA Officer Approved By: Print Name: Branch Chief Date Issued: ___/___/___ Date: ___/___/___

Withdrawn By:

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Controlled Copy No.: ___________________

SOP No.QC-05-03 Date Revised 06-28-05 Page 1 of 8

TABLE OF CONTENTS

Contents 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0

Page Number

SCOPE AND APPLICATION.......................................................... 2 DEFINITIONS................................................................................... 2 HEALTH AND SAFETY.................................................................. 2 CAUTIONS....................................................................................... 2 INTERFERENCES............................................................................ 2 PERSONNEL QUALIFICATIONS.................................................. 2 SPECIAL APPARATUS AND MATERIALS................................. 2 INSTRUMENT OR METHOD CALIBRATION............................. 4 SAMPLE HANDLING AND STORAGE......................................... 4 PROCEDURE AND ANALYSIS..................................................... 4 DATA ANALYSIS/CALCULATIONS............................................ 4 DATA MANAGEMENT/RECORDS MANAGEMENT................. 4 QUALITY CONTROL...................................................................... 5 NONCONFORMANCE AND CORRECTIVE ACTION................ 5 REFERENCES.................................................................................. 5 FORMS AND DATA SHEETS........................................................ 5

SOP No.QC-05-03 Date Revised 06-28-05 Page 2 of 8

1.0

SCOPE AND APPLICATION: 1.1 This protocol describes the procedures for recording the temperature of laboratory incubators, refrigerators and freezers.

2.0

DEFINITIONS: 2.1 2.2 ASTM = American Society for Testing and Materials NIST = National Institute of Standards and Technology

3.0 4.0 5.0 6.0

HEALTH AND SAFETY: Not applicable CAUTIONS: None INTERFERENCES: None PERSONNEL QUALIFICATIONS: 6.1 Personnel are required to be knowledgeable about the procedures in this SOP.

7.0

SPECIAL APPARATUS AND MATERIALS: 7.1 Incubator No. 1-4, 6 and 10-16 are large capacity Precision Incubators, Model No. 30M. 7.1.1 7.1.2 7.1.3 7.1.4 7.1.5 7.1.6 Incubator No. 1. Serial No. 699010761. Location: Room B204. Incubator No. 2. Serial No. 699010763. Location: Room B204. Incubator No. 3. Serial No. 698110167. Location: Room B204. Incubator No. 4. Serial No. 698110166. Location: Room B204. Incubator No. 6. Serial No. 699021013. Location: Room B207. Incubator No. 7, Serial No.9211-005 Precision Incubators bench top incubator Model No. 2EG. Location: Room B202. Incubator No. 8. Serial No. 06046. Boekel Industries bench top incubator Model 132000. Location: Room B201.

7.1.7

SOP No.QC-05-03 Date Revised 06-28-05 Page 3 of 8

7.1.8

Incubator No. 9. Serial No. 0799-0160. LAB-LINE Bench top Incubator, Imperial III. Location: Room B202. Incubator No. 10. Serial No. 6000529. Location: Room B203.

7.1.9

7.1.10 Incubator No. 11. Serial No. 6000528. Location: Room B203. 7.1.11 Incubator No. 12. Serial No. 6000527. Location: Room B203. 7.1.12 Incubator No. 13. Serial No. 699021012. Location: Room B203. 7.1.13 Incubator No. 14. Serial No. 600041067. Location: Room B202. 7.1.14 Incubator No. 15. Serial No. 600041066. Location: Room B202. 7.1.15 Incubator No. 16. Serial No. 600041068. Location: Room B202. 7.1.16 Incubator No. 17. Serial No. U15N-400053-UN. Location: Room B207. 7.2 Refrigerators/Freezers: 7.2.1 Refrigerator No. 1R Summit - Model No. BI-605J. Serial No.970900695. Location: Room B207. Refrigerator/Freezer No. 2R/2F White Westinghouse Refrigerator/Freezer - Model No. WRT17CGAWO. Serial No. BA32603844. Location: Room B206. Refrigerator/Freezer No. 3R/3F White-Westinghouse Refrigerator/Freezer. Model No. WRT17CGAWO. Serial No. BA32403117. Location: Room B205. Refrigerator No. 5R Summit - Model No. BI-605J. Serial No. 970900676. Location: Room B205. Refrigerator No. 6R Summit - Model No. BI-605J. Serial No. 970900665. Location: Room B207. Refrigerator No. 7R Revco Technologies - Model No. RFS214A14. Serial No. P09K-476736-PK. Location: Room B204.

7.2.2

7.2.3

7.2.4

7.2.5

7.2.6

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7.2.7

Refrigerator No. 8R Revco Technologies - Model No. RFS214A14. Serial No. R02L-52413-RL. Location: Room B202. Freezer No. 9F Revco Technologies - Model No. ULT390-5-A30. Serial No. U08J-443679-UJ. Location: Room B209. Freezer No. 10F Revco Technologies - Model No. ULT1740-3-A36. Serial No. U07N-200015-UN. Location: Room 203.

7.2.8

7.2.9

7.2.10 Refrigerator No. 11R Fisher Scientific - Model Isotemp Plus. Serial No. 410N0005. Location: Room B201. 7.3 Thermometers directly traceable to or certified by the NIST or ASTM are used to monitor temperatures of individual incubators, refrigerators and freezers.

8.0

INSTRUMENT OR METHOD CALIBRATION: 8.1 Thermometers are calibrated according to SOP EQ-02, Calibration of Thermometers.

9.0 10.0

SAMPLE HANDLING AND STORAGE: Not applicable PROCEDURE AND ANALYSIS: 10.1 The temperature of each instrument will be recorded once daily each working day (Monday through Friday excluding holidays and days when the ESC is closed for any reason) on the appropriate Temperature Record form (see 16.0). On weekends, holidays and days when the ESC is closed, note the reason why the temperature is not recorded under Maintenance and Notes on the appropriate Temperature Record form (see 16.0).

11.0 12.0

DATA ANALYSIS/CALCULATIONS: None DATA MANAGEMENT/RECORDS MANAGEMENT: 12.1 The temperature of each incubator, refrigerator and freezer is to be recorded promptly, legibly and in indelible ink on the appropriate incubator, refrigerator or freezer temperature record form. Completed forms are archived on a yearly basis in notebooks kept in secured file cabinets in the file room D217. Archived data are subject to OPP=s official retention schedule contained in SOP ADM-03,

SOP No.QC-05-03 Date Revised 06-28-05 Page 5 of 8

Records and Archives. 13.0 QUALITY CONTROL: 13.1 For quality control purposes, the required information is documented on the appropriate forms. The thermometers are point checked annually against a NIST traceable thermometer. A piece of label tape, 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.

13.2

14.0

NONCONFORMANCE AND CORRECTIVE ACTION: 14.1 Any deviation from the standard procedures will be documented in the record book 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.

15.0 16.0

REFERENCES: None FORMS AND DATA SHEETS: 16.1 16.2 16.3 Incubator Temperature Record Refrigerator Temperature Record Freezer Temperature Record

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Incubator Temperature Record

OPP Microbiology Laboratory
Month/Year: _______/____ Incubator Target Temp: ___"1EC 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 * Corrected temperature recorded Time/ Init. Temp.* Laboratory #/Incubator ID: _____/_____ Thermometer ID/Correction Factor: _______/___EC Adjustments Necessary Maintenance and Notes

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Refrigerator Temperature Record

OPP Microbiology Laboratory
Month/Year: _______/____ Refrigerator Target Temp: ______EC 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 * Corrected temperature recorded Time/ Init. Temp.* Laboratory #/Refrigerator ID: _____/_____ Thermometer ID/Correction Factor: _______/___EC Adjustments Necessary Maintenance and Notes

SOP No.QC-05-03 Date Revised 06-28-05 Page 8 of 8

Freezer Temperature Record

OPP Microbiology Laboratory
Month/Year: _______/____ Freezer Target Temp: ______EC 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 * Corrected temperature recorded Time/ Init. Temp.* Laboratory #/Freezer ID: _____/_____ Thermometer ID/Correction Factor: _______/___EC Adjustments Necessary Maintenance and Notes