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 compounding of CSPs. These classifications ensure that a designated zone is maintained in a clean state. The monitoring program is designed based upon 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 implementation of corrections to prevent CSP contamination.
The paper includes information on the most recent 797 updates and recommendations.
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Particle Measuring Systems can help you meet your USP 797 monitoring requirements with these solutions: