EO sterilization out of specification and correction

ifserav

Involved In Discussions
#1
A EO sterilization process of one of my customers is quite frequently (approx. 15 %) out of spec (OOS) in the heated aeration or passive aeration (storing after heated aeration) mainly due to power cuts or also other root causes. The times OOS are made up (extra x hours in the heated aeration) and the deviations are always evaluated and the sterilization lots released by "special release procedure".
We are planning to implement a QA approved "action matrix" or "deficiency matrix", so that in case of OOS it would be clearly defined what to do (e.g. "keep goods for 5 h longer in heated aeration") and the sterilization lot could be released without overstraining the complicated "special release procedure".

Would this kind of "deficiency matrix" be an acceptable approach? Would there be a limit for the frequency to use of such process?
 
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planB

Super Moderator
#2
ifserav,

in my opinion, a process with an OOS frequency of 15 % is unstable, and especially for a critical process like sterilization unacceptable.

If you cannot avoid power cuts and similar issues, consider extending your process specification to account for the extra required aeration time. Since aeration time affects EO sterilization residuals, aim at demonstrating safe residual levels for your worst-case power hiccup scenario.

In case you succeed in validating this scenario, you can safely release your batch without having to over-strain OOS procedures and resort to frequently justifying deviations - much fewer headaches for you and raising of eye-brows by third-party auditors.

HTH,

Gerhard
 
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