Continuous Microbial Air Monitoring in Clean Room Environments

Overview

Environmental monitoring is an important part of quality assurance for the production environments of sterile pharmaceutical products. Especially for aseptic filling lines where products are filled without a terminal sterilization step it is of utmost importance for product safety and thus an essential part of the quality control strategy. Such ISO 5 graded manufacturing environments are required to have < 1 colony-forming unit (CFU) per m³ of air.

The following study aimed to establish whether a continuous sampling (and multisampling point assay) provides effective monitoring for the entire production process (8h) by determining whether trapped organisms can withstand long-term drying stress with unaltered recovery. Be prepared for Annex 1 regulations and download our application note.

• Document type: Application Note
• Page count: 6
• Read time: 10 minutes

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