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.
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