SOP for Recording of Differential Pressure in Production Area

1.0 OBJECTIVE

To lay down the procedure for recording of differential pressure in the Production area.

2.0 SCOPE

This SOP shall be applicable for the recording of differential pressure in the Production department.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production/ Assigned Designee

5.0 PROCEDURE

5.1 Ensure that air handling system is “ON”.
5.2 Open the cubicle door and adjust the “Zero” on the gauge with adjusting screw.
5.3 Close all the doors.
5.4 Read on magnehelic gauge pressure difference of cubical against the corridor.
5.5 The air pressure corridor should be positive against the processing area limit is between 10-20 Pascal and for airlock between 10-20 Pascal.
5.6 Record the pressure differential in the format “Record of Differential Pressure”.
RECORDING TIME: Two times in a shift.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department

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