Dear all … is it mandatory to involve the leak test in the media fill for ampoules aseptic filling validation ? And why is that while we are using media that will reveal any leak by showing contamination if there is any
Yes it is mandatory to test vials for leakage because you have to ensure that contamination in vials is due to process but not due to the leakage.
PIC/S Recommendation on the validation of aseptic processes (an OLD guidance 2011):
https://www.gmp-compliance.org/files/guidemgr/PI 007-6 Recommendation on Aseptic Processes.pdf
WHO Annex 2 TRS 1044 (2022):
FDA Guidance Document Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products:
"A- Container-Closure Integrity
The ability of the container-closure system to maintain the integrity of its microbial barrier, and, hence, the sterility of a drug product throughout its shelf life, should be demonstrated. Reference is made to sections II.E. and IV.G. of this guidance. As previously stated, sterility testing at the initial time point is not considered sufficient to demonstrate the microbial integrity of a container-closure system. Documentation of the sensitivity of the container-closure integrity test should be provided."
Thank you sir for responding … but i was asking about ampoules (not vials )… is it mandatory also to test 100 % of the media batch for leakage ?
Thank you sir for responding… but in PIC/S i think the integrity of containers is only checked by inspecting the media after 14 days while integrity test is done for 100 % of the product batch not for media batches of ampoules(as in WHO Annex 2 TRS 1044) ? Do you think this opinion is rational?
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