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A pass box also called a hatch is a piece of equipment used to transfer pharmaceutical ingredients from a low cleanliness area to a high cleanliness area and vice versa. Hence, they act as a barrier between areas with different levels of cleanliness.
In production areas, pass boxes are used to transfer materials before mixing, granulating or sterilizing. Boxes are also used in microbiology laboratories for sterilization and incubation.
Pass boxes are very important as they help prevent air flow from one area to another aseptic GMP clean room area when transferring pharmaceutical materials. To ensure their functionality, pass boxes are usually not made with interlocking door systems. This feature ensures that only one door can be opened at a time and not both doors.
There are two types of pass boxes, dynamic pass boxes and static pass boxes. Dynamic pass boxes, similar to pharmaceutical airlocks, can be of the cascade, sink or bubble type.
These boxes act much like an airlock to allow clean air to enter the pass box and prevent the entry of contaminants. Static pass boxes are also called passive pass boxes. These are simple boxes that can be mounted between two different cleaning areas.
An area with a high level of cleanliness must have high pressure to sterilize the space and ensure contamination is prevented. Usually, an ultra-violet light is installed in the pass boxes to remove contamination that may enter during the transfer of pharmaceutical materials.
Pass box validation in pharmaceuticals is a quality assurance and quality management process that includes documented evidence of the consistency of a process or system. Therefore, it is verifying the efficiency of the equipment in preparation for work.
Validation is an inevitable process and can be done by exposing pass boxes to known populations of bacterial cultures to ensure that bacteria cannot enter and contaminate the boxes. This process should be done at different stages of product production. Verification is a very necessary process in the case of pass boxes in pharmaceuticals.
Validation of the pass box can also be done by exposing the media plates in the pass box or by opening the door in a low cleanliness area or you can develop any other suitable and convenient method.
