Environmental Monitoring Trend Analysis and Definition of Alert and Action Limits
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.
This document provides technical information and recommended methods for sampling compressed gas using the Lasair® III Particle Counter in combination with the High Pressure Diffuser III (HPD III).