USP 797 Viable Non-Viable Monitoring Insights

Viable Non-Viable Environmental Monitoring to Meet USP 797

According to USP 797, critical areas must continuously meet ISO Class 5 or better conditions for 0.5 μm particles, and must exclude microbial contamination during the compounding of CSP’s. These classifications ensure that a designated zone is maintained in a clean state. The monitoring program is designed based on contamination risk to finished product quality.

An effective environmental monitoring program provides meaningful information on the quality of the compounding environment and any environmental trends in surrounding areas.

In addition, an effective environmental monitoring program will identify potential routes of contamination, allowing for the implementation of corrections to prevent CSP contamination.

The paper includes information on the most recent 797 updates and recommendations.


Particle Measuring Systems can help you meet your USP 797 monitoring requirements with these solutions:

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