Environmental Monitoring Vs. Good Aseptic Technique

The production of modern medicinal injectable products requires good aseptic techniques, stringent manufacturing practices, and/or terminal sterilization, to control the encroachment of the manufacturing environment into a high-risk zone. ISO standards and GMP guidelines exist that promote the application of good aseptic practices and are typically demonstrated using a suitable monitoring program.

So, what suitable environmental monitoring is necessary to comply with the requirements of ISO and regulatory bodies? This webinar reviews how the standards and regulations promote a cohesive environmental program that applies to the risks of specific manufacturing environments and explores manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.