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QA SOP

SOP Title: Pressure Differential Monitoring

SOP Title: Pressure Differential Monitoring

 

  1. Objective:

To lay down a procedure for monitoring of Pressure Differential within the facility to control the flow of the air.

  1. Scope:

This procedure is applicable for monitoring of pressure differential in the critical areas in Production, Warehouse and Quality Control Laboratory.

  1. Responsibility:

3.1 Concerned Department: To follow the procedure laid down and ensure that the area is maintained with the defined differential pressure.

3.2 Engineering Department: To check, verify and ensure that all the Magnehelic Gauges are working properly.

3.3 Quality Assurance Department: To review and approve the SOP. To ensure compliance of the SOP.

  1. Accountability:

Head Concerned Department and Head Quality Assurance Department.

  1. Procedure:
    • Definitions:

5.1.1 Pressure Differential: Pressure Differential is the difference in air pressure between two cubicles/areas which is connected and measured by the Magnehelic Gauge.

 

5.2 Procedure:               

5.2.1 Instrument Used  
5.2.1.1 Magnehelic Gauge  
5.2.2 Ensure that the Magenehelic Gauge is within the calibration validity state and working properly.  
5.2.3 Ensure that the area is supplied with the desired airflow and respective AHU system is in operation for at least five minutes.  
5.2.4 Ensure that all the doors are closed properly and there is no movement across the doors during pressure differential recording.  
5.2.5 Record the pressure differential reading /value as indicated by the needle of the Magnehelic Gauge in specified format as mentioned in Annexure as applicable to particular area.  
5.2.6 Ensure that the pressure differential is well within the defined limit.  
5.2.7 Frequency  
5.2.7.1 Pressure differential shall be monitored twice a shift i.e. at about 09:00 Hrs and 15:00 Hrs. If there is no activity pressure differential shall be monitored once a shift.  
5.2.8 In case of non compliance of pressure differential specification, it shall be immediately reported to the Concerned Department Head and Corrective Action shall be taken.  

 

  1. Abbreviation:
Abbreviation Expansion
SOP Standard Operating Procedure
QAD Quality Assurance Department
UTL Utility
i.e. Id Est (That is)
NLT Not Less Than
NMT Not More Than
mm Millimetre
AHU Air Handling Unit
Hrs Hours

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

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