FDA Guidance for industry states Airlocks

“Air change rate is another important clean room design parameter. For Class 100,000 ( ISO 8 ) supporting rooms, airflow sufficient to achieve at least 20 air changes per hour is typically acceptable.” Design requires hard numbers, so there is temptation for the design team to use this statement as a final Quality position—that 20 air changes is acceptable in a Grade C area.”

Adjacent rooms of different grades should have a pressure differential of 10-15 pascals (guidance values) and 12.5 Pa between a classified and non-classified room.

Doors of the airlocks should be open to higher pressure side which help to close the door.

Interlocking system should be provided to prevent the opening of both doors at a time.

An alarm should be provided to indicate that one door is opened. It helps to prevent the entry of contamination through the airlocks.

Higher air changes per hour rate should be maintained in the airlock, it should be minimum 20 air changes per hour. It helps to remove the contaminants entered from the outside easily.

Airlocks should be kept empty, material such as garments, shoes covers etc. should not kept in the airlocks. I have observed it many times in pharmaceuticals keeping these articles in airlocks.

In Pharmaceutical, Bio-Pharmaceutical and sterile manufacturing, the clean room environment is the major prerequisite for all manufacturing activity: without a proper movement mechanism & background environment, no medicine can be produced for patient consumption.

The intentions and purpose are the reality of stable, reliant, and compliant operation within a tightly controlled and monitored environment. Tight User Requirements or Design Philosophies must be written or inked down before building Airlocks in clean rooms. The challenge for any Quality unit is to define URS based on regulatory considerations when the facility exports a product in different regulatory areas.

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