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Industry Survey on Sterile Connection Devices by Milind Jog is a document available to read on EtoBox.
What is Industry Survey on Sterile Connection Devices about?
The document discusses the results of a survey conducted by the PDA regarding intrinsic sterile connection devices used in aseptic manufacturing, particularly in light of the revised EU GMP Annex 1. The survey revealed that most industry users employ these devices in Grade C or lower environments, which is now deemed acceptable, but highlights a lack of standard guidance on their validation and control. Additionally, there is no clear preference between tube welders and mechanical sterile connectors, althou
- Author
- Milind Jog
- Language
- EN