Strategies and Standards for Effective Microbial Monitoring in Cleanroom Environments
In pharmaceutical manufacturing, maintaining a contamination-free environment is critical—not just for product quality, but for patient safety. This paper offers a comprehensive look at how cleanrooms are managed to control both inert particles and microbiological entities and explains why environmental monitoring (EM) programs must include both total particulate and microbiological components. While fewer particles may suggest lower microbial risk, this assumption only holds if human operators are the primary source of contamination. Mechanical operations and background sources complicate the picture, making dual monitoring essential.
Whether you’re working with terminally sterilized products or aseptically prepared ones, this resource helps you understand how to maintain a stable and compliant cleanroom environment. It’s a must-read for professionals involved in contamination control, quality assurance, and regulatory compliance.
Interested in learning more? Complete the form on this page to receive a free copy of the Microbial Control and Monitoring in Aseptic Processing Cleanrooms application note.