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Effective Execution of the Microbial, Environmental, and Utility Testing in Cleanroom Qualification

The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of clean room commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drug products, medical supplies, or other manufactured products.

The first step of commissioning is the qualification of the air handling systems and HEPA filters, which involves establishing the appropriate airflow rates, patterns and pressure differentials. Air flow should move from a cleaner classification to a less clean one. Smoke studies are also sometimes implemented during this stage to visually confirm that the air flow is acting appropriately within the space. It is always appropriate to consider performing a smoke study within spaces where open processing will occur.

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