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IPCD Sterility test failure during MPQ (EO sterilization validation)

B

brianthermophilus

#1
Hello,

I could use some help in determining how to rationalize a recent IPCD failure during a EO sterilization validation.

Of the 3 half cycles run we had (1) IPCD that showed growth (non-contamination) that was located at the top of the pallet. The IPCD's were doubled up and the one beside it did not show growth. I've investigated the positioning of the IPCDs along with variables of the cycle and nothing seems to be out of the ordinary.

To avoid repeating an additional 3 half cycles, I'm looking to rationalize this (1) IPCD failure but unfortunately since it wasn't a result of contamination or an equipment issue I'm running into road blocks within ISO11135.

Has anyone had experience in IPCD failures during MPQ and talking your way out of it? Maybe I'm missing something?

Thank you!
 
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M

MIREGMGR

#3
I don't think it's a good idea to write a rationale for why an issue is not a problem, when you don't understand what happened.

If it takes more testing, maybe with some variable exploration, to figure that out, you'll end up with a better-understood process in return for your additional investment of cycle costs and time.
 
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