SOP for Monitoring of Deferential Air Pressure in Production

Objective

This SOP's objective is to provide detailed instructions and procedural control for monitoring deferential air pressure in the Production area.

Scope

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

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 for performing the activity.

Checking: Production Supervisor, Technical Staff, and above to counter-check the activity.

Accountability

HOD: Production/Assigned Designee for Overall Implementation in the System with effective procedural control to compliance.

HOD: Production/Assigned Designee for Overall Implementation in the System with powerful Procedural manipulation 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 inform 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.

ALSO READ: Maintenance of Pressure Differential in Manufacturing Area

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 areas 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 halves of the shift while processing is on.
• After completion of the 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

ALSO READ: SOP for Good Manufacturing Practices in Production Area