Viable and Non-Viable Environmental Monitoring to Meet USP <797>
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.
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.
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 recommendations for monitoring solutions to meet regulatory requirements including the Lasair III for Particle Counting and Handilaz Mini for non-viable monitoring and the MiniCapt Mobile Microbial Air Sampler and the BioCapt Single-Use Microbial Impactor for viable monitoring.