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SOP for Monitoring of Deferential Air Pressure in Production

Objective
The Objective of this SOP is to provide detailed instructions and procedural control for monitoring of deferential air pressure in the Production area.

Scope
The scope of the SOP shall be applicable for detailed procedures as the air is being the major media for contamination, and can be effectively handled by controlling of air pressure differential in the production area, thereby ensuring the required processing area to manufacture quality products. This SOP provides clear guidelines to monitor the pressure differential in the production area and maintain the pressure differential as per requirement.

This also provides basic requirements, and necessary precautions taken while monitoring the air pressure deferential in the production area.

Responsibility
Performance: Worker, Operator and Technician Responsible to perform the activity.
Checking: Production Supervisor, Technical Staff and above to counter-check the activity.

Accountability
HOD: Production/Assigned Designee for Overall Implementation in System with effective procedural control to compliance.
HOD: Production/Assigned Designee for Overall Implementation in System with powerful Procedural manipulate to compliance.


Procedure
  • Check that AHU is “ON” position.
  • Note down the Magnehelic gauge reading.
  • Record the reading in the respective log book.
  • Check that the differential air pressure complies with the specified limits as per Annexure – I
  • If the gauge is not working properly or pressure deference is out of limit stop the processing in the respective area and intimate the maintenance dept. to rectify the difference.
  • After rectifying the deference, repeat step no. (1) to (4).
  • Tightly close all the in-process materials in the respective area, till the corrective action is done.
Precaution: 
  • Ensure that over-printed labels, labeled corrugated boxes and over-printed cartons are put into the waste bin after crushing or tearing off.
  • Waste generated (like polythene bags, nylon threads, and hand gloves) from primary processing area like OSD Facility, Injection Facility, liquid oral Facility, and External Preparation Facility are to be disposed of separately.
  • Necessary precaution for safety concerns and others if applicable as required.
Acceptance Criteria:
  • AHU must be in the “ON” position while monitoring the air pressure deferential.
  • Magnehelic gauges should be calibrated.
  • Check the proper working of the gauge by opening the door of the respective area. 
  • Ensure that the area under the observation door is properly closed and there are no men or material movements during the recording.
  • The pressure differential is to be monitored at the time of production.
  • This procedure is applicable for all Magnehelic gauges that were ever provided.
  • The material should be stored at a temperature of 25°C + 5°C
Frequency:
  • Once in both half of shift while processing is on.
  • After completion of batch or at the end of the day.


Abbreviation
SOP: Standard Operating Procedure
AHU: Air Handling Unit.
QC: Quality Control
Q.A: Quality Assurance
HOD: Head of the Department

Annexure
Annexure – I
Location Limit : Temperature 25 ± 5°C, Relative humidity not more than 50 ± 5%
Observation frequency: Twice in Shift (First half 8: 30 to 12:30) (Second half 13:00 to17:00)


Revision History
Nil

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