Hi, all.
We qualified our autoclaves.Now we have to write plan or SOP for OOC cases, for example power or water failure.If someone knows what to do in this cases please write.
The most widely used Risk Assessment tool in Pharmaceutical Industry is Failure Mode Effects Analysis (FMEA). FMEA analyse Probability of Occurrence, Severity and Probability of Detection. Depending on the Probability of Occurrence (O), Severity (S) and Probability of Detection (D) overall risk can be graded as low, medium or high level. The risk must be defined as acceptable, unacceptable or intolerable in accordance to the most critical evaluation of the different risk levels for the parameters Probability of Occurrence, Severity and Probability of Detection.
Dear joksavs, if you know exactly what to do if during sterilization occur power, steam or water failure for autoclave please write it.Risk assessment tools isn’t that what we need.We need to know what to do at the moment when failure occur.Ex. resterilize after failure, or reject batch?