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?
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?