Continuous Microbial Air Monitoring in Clean Room Environments
Authors: Claudia Scherwing, Jasmin Bunke | Last updated: February 2019
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
Key Takeaways
- Learn how to benefit from implementing continuous microbial air monitoring to entire manufacturing and quality control process of your medical devices.
This Resource is Designed for:
- Lab Researchers
- Lab Technicians
- Lab Post Doc
- Scientists
- Engineers
Applications Supported:
- Life Science Research
- Applied Industries
- Quality Control & Testing
- Air Monitoring