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What is New Annex 1 Challenges in Life Sciences about?

The new Annex 1 places greater emphasis on a holistic approach to contamination control strategies in the pharmaceutical industry. Some of the biggest challenges for sterilization processes include the new requirement to sterilize both direct and indirect contact parts of equipment used for aseptic processing. There are also specific challenges for freeze-dried products and sterilizing narrow pipework and hoses. Proper packaging, condensate management to prevent wet loads, and ensuring adequate steam penetr

Author

CalVal2006

Language

EN