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The current USP requirements for particle monitoring can be summarized as ‘to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications.’ Therefore, laminar flow hoods used in the manipulation of sterile product should meet ISO 5 limits. Background areas and ante rooms should meet either ISO 7 or ISO 8, depending on the activities performed in those areas.

To ensure that the designated zone is maintained in a clean state, a particle monitoring program should be designed based upon contamination risk to finished product quality. The ISO 14644-2 standard is referenced and is the recertification schedule for proving continued compliance. However, this is not a monitoring program. The Parenteral Drug Association (PDA) offers guidance pertaining to monitoring frequency which is based upon risk in manufacturing environments and is in accord with FDA requirements.

Click here to download the full paper: Click here to signup and download files (Quick Steps to Meet USP 797 Compliance)