Validation of Clean Room Pass Boxes : Pharmaceutical Guidelines

Validation of Clean Room Pass Boxes

Pass boxes play an important role in maintenance of clean rooms. Pass boxes must be validated to ensure their performance during operation.
A pass box which is also called a hatch is an equipment which is used to transfer pharmaceutical material from an area of lower cleanliness to an area of higher cleanliness and vise-versa. They, therefore, work as a barrier between areas with different levels of cleanliness.

In manufacturing areas, pass boxes are used for transferring materials before blending, granulation or sterilization. The boxes are also used in microbiology laboratory for sterilization and incubation.

Pass boxes are very important because they help to prevent air flow from one area to another aseptic clean room area while in the process of transferring pharmaceutical material. To ensure effectiveness in their working, pass boxes are usually not made with an interlocking door system. This characteristic ensures that one door can be opened at a time and not both doors.

Clean room pass box

There are two types of pass boxes, the dynamic pass box and the static pass box. Dynamic pass boxes which are similar to airlocks in pharmaceutical may be of cascade, sink or bubble type.

These boxes work much like airlocks by allowing clean air to enter the pass boxes and prevent the entrance of contaminants. Static pass boxes are also called passive pass boxes. They are simple boxes that can be mounted between two different cleanliness areas.

An area with higher cleanliness level shall have higher pressure to sterilize the place and make sure that contamination is prevented. Usually, the pass boxes have an ultra-violet light installed on them to remove the contamination that may enter during the transfer of pharmaceutical materials.

Validation of pass boxes in pharmaceuticals is a quality assurance and quality management process that entails documented evidence of consistency of any process or system. Therefore, it is verifying the efficiency of the equipment in readiness for work.

Validation is an inevitable process and may be done by exposing the pass boxes to a known population of bacterial culture to establish whether bacteria can enter and contaminate the boxes. This process should be carried out at various stages of product production. Whichever the case validation of pass boxes in pharmaceutical is a very essential process.

Validation of pass boxes can also be done by exposing the media plates in pass boxes during the use or by opening the door to the less cleanliness area or you can develop any other suitable and convenient method.

The following reasons contribute to the importance of validation:
1. Validation of pass boxes ensures the risk-free transfer of the material from less cleanliness area to higher cleanliness area with cleanroom regulations.
2. The validation process may lead to a deep study and understanding of the equipment.
3. It eliminates the risk of regulatory non-compliance.

Considering the many benefits that can be gained when validation of pass boxes in pharmaceutical is carried out we would encourage all dealers and professional to ensure that the process is not passed over. Share your views and suggestions pass boxing and clean room conditions in the comments section.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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