STANDARD OPERATING PROCEDURE Monitoring and Recording of Temperature & Pressure Differential in Microbiology Laboratory

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/
Monitoring and Recording of Temperature & Pressure Differential in Microbiology Laboratory		Effective Date:
		Review Date:
		Page No.:

1.0            OBJECTIVE:

1.1                   To lay down a procedure for monitoring and recording the temperature and Pressure Differential in Microbiology laboratory.

2.0            SCOPE:

2.1                   This procedure is applicable for monitoring and recording the temperature and Pressure Differential in microbiology laboratory at  Pharma Private Limited.

3.0            RESPONSIBILITY:

3.1                   Microbiologist/QC Designee: Responsible for monitoring and recording the temperature and Pressure Differential.

3.2                   Section In-charge: Responsible for review the procedure.

3.3                   QC Head: Responsible for implementing the procedure.

3.4                   QA Head: Overall compliance.     

4.0            PROCEDURE:

4.1                   Pressure Differential shall be recorded thrice in shift i.e., starting of the shift, afternoon or before micro activity carried out and ending of the shift for the following areas by using Magnehelic gauge.

4.1.1             Cool zone (84)

4.1.2             LAF - I (82)

4.1.3             LAF - II (83)

4.1.4             Culture Storage Area (81)

4.1.5             Corridor

4.1.6             Change Room II (79)

4.1.7             Micro Office (78)

4.1.8             Media Preparation Room (75 a)

4.1.9             Media storage room (80)

4.2                 Temperature shall be recorded thrice in shift i.e., starting of the shift, afternoon or before micro activity carried out and ending of the shift for the following areas by using Thermo Hygro meters.

4.2.1             Cool zone (84)

4.2.2             LAF - I (82)

4.2.3             LAF - II (83)

4.2.4             Culture Storage Area (81)

4.2.5             Incubator room (112a)

4.2.6             Media Preparation Room (75 a)

4.2.7             Media storage room (80)

4.3                 Temperature shall be entered in Annexure – I.

4.4                 Pressure Differential shall be entered in Annexure – II.

4.5                 The Acceptance criterion for temperature monitoring is NMT 25°C.

4.6                 The Acceptance criterion for pressure differential is NLT 0.6mm of water gauge.

4.7                   If any breakdown or maintenance of Thermohygro meter or Magnehelic gauge use standby thermo hygrometer or Magnehelic gauge for monitoring the temperature and pressure differentials.       

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
LAF: Laminar air flow	NLT: Not Less Than
SOP: Standard Operating Procedure	NMT: Not More Than