recently I am working on HCT/ps (Human cell and tissue products). I have already searched a lot about sterility test for such a product but I couldn't find a authentic protocol from USP, CFR ,...
Would you please give me a recommendation? Thank you in advance
Dear Dibakar Pal,
Thank you so much for all information that you put here. Actually I have read all of this. Non of them dose not mention about sterility test protocol in HCT/ps. Most of them are about regulatory I need a proper protocol for HCT/ps finished product sterility test .
Hello Zahra,
I believe you have already read this paper (Please see attached), in particular, see table 2
These standards also might be useful to plan the required test
ISO 13408 :Aseptic processing of health care
ISO 11138 and 38 : Sterilization of health care products
I hope it will help
Amin
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