SOP for Recording of Differential Pressure in Production Area : Pharmaceutical Guidelines

SOP for Recording of Differential Pressure in Production Area

Standard operating procedure to record the differential pressure in Production Area.

1.0  OBJECTIVE:

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

2.0  SCOPE:

       This SOP shall be applicable for recording of differential pressure in 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 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



Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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