Change Rooms and Airlocks in GMP Area

A pharmaceutical GMP (Good Manufacturing Practice) facility must be developed to minimize risks associated with pharmaceutical manufacturing that cannot be avoided through final product testing. The GMP system is a protocol to follow which ensures that products are consistently produced and controlled according to quality standards.

Cleanroom facilities are areas designed only to perform such cleaning processes inside pharmaceutical facilities. Before entering the cleanroom, there are certain protocols and guidelines that workers must follow. Designing airlocks and change rooms with optimal safety measures helps the cleanroom achieve maximum standards.

An airlock is a room between the clean room and the less clean area surrounding the clean room (where the most important work is done) or between areas of different cleanliness classes. Airlocks run at maximum air pressure at maximum speed to blow out particles that could contaminate the room. When a worker or materials or equipment are moved in or out of the clean environment, they must come through the airlock. It can be the size of a small “closet” or a large room that a forklift can enter with large equipment.

The main use of airlocks is to allow people and equipment to access the cleanroom without disturbing the positive air pressure. Most airlocks have an interlock feature that prevents both doors from opening simultaneously. To transfer an equipment, it is recommended to show an indicator light when the door is open.

Change room is the dressing room where the employee changes into clean clothes by leaving his dirty clothes in the change room. In some GMP pharmaceutical facilities, an airlock serves as a gowning area, which is a bad idea.

If you want a good cleanroom facility of high quality, an airlock and change room should be separate. At the very least, the change room should have a separate chamber that allows staff to change and store their outerwear in the chamber before entering the airlock.

Change rooms should be designed to support established garment protocols for FDA GMP facilities. A typical changing room should follow the following guidelines.
=>> Personal lockers for keeping keys, mobiles, notebooks, coats and other personal belongings which should be outside the dressing room.
=>> Coat rack for storing coats or other clothing in an antechamber outside the dressing room or adjacent to the clean dressing area.
=>> A wall is mounted for hanging outerwear to avoid floor contamination.
=>> Trash bins to dispose of unwanted items or soiled clothing before entering the clean room.
=>> Storage area for cleanroom clothing.

Designed this way, gowning is not done in an airlock and the person entering the airlock is already in his clean clothes which ensures more security. The concept of keeping the airlock separate from the changing room makes cleanroom safety guidelines more effective.

Pharmaceutical and biopharmaceutical facilities with GMP standards are meant to treat diseases and develop immunity for patients. Without a proper facility design, they cannot produce clean and sterile products that prevent any contamination from bacteria or allergens or disease-causing agents.

A proper skill is to design, qualify and operate such clean room facilities with good airlocks and separate change rooms. In a word we would say airlocks are the heart of the cleanroom. Keeping the airlock free of contamination is very important.

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