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EU24CEMAR1/SES309 - Validation of a Fully Gloveless Aseptic Isolator

‐ Mar 13, 2024 11:45am

Aseptically processed biopharmaceuticals and emerging technologies create increasing demands on H2O2 decontamination cycle times, effectiveness and permitted H2O2 residual limits.
This presentation guides through the latest innovations in H2O2 decontamination solution with its advantages and meeting the latest cGMP and regulatory requirements i.e., Annex 1. With the development of H2O2 decontamination cycles on a fully gloveless isolators new challenges will be discovered and according processes need to be established.
Furthermore, a process for cleaning and quantification of cleaning for a fully gloveless automated filling line needs to be established and validated.
Therefore, bullet points which needs to be covered for both validation steps will be:
- Goal 
- Approach
- General aspects 
- Tools
- Challenges