Could anyone helps me? My boss asked me to do a validation of a new process, he used this words
"FDA would like to see a 5 log reduction of Clostridium botulinum, we probably need to inoculate the Clostridium botulinum for this test. We need to demonstrate that neither the bacteria nor spores are passing this process."
So what should I start? I think Clostridium botulinum is very dangerous to do an enrichment to get log 5. Is FDA really wants a 5 log reduction of Clostridium botulinum not a TPC?
Thank you in advance
You need to add some context to get directly relevant responses, eg -
Is this the USFDA or local FDA ?
5log sounds like some form of pasteurization rather than sterilization ? Yes ?
What kind of product / process is being studied ? if Pasteurization for C.bot. a certain range of products / processes are usually involved ?
Various approaches to validating pasteurizations exist which may depend on the specific situation, eg local (?) FDA requirement. It is possible that a substitute, non-pathogenic species for C.bot type XYZ exists or perhaps you can validate the maximum existing level of C.bot in yr input material and then validate the thermal process applied / level in finished product (this is a common approach for L.mono.) It all depends on the specific case.
FDA would like to see a 5 log reduction of Clostridium botulinum, we probably need to inoculate the Clostridium botulinum for this test. We need to demonstrate that neither the bacteria nor spores are passing this process."
The last sentence looks confused. The usual pasteurization requirement is to demonstrate that the population count of target species is reduced by >=5log or whatever the standard requires. This procedure does not prove that there is no residual C.bot. ( typically the objective of sterilization via >= 12 log reduction).
Please clarify a little.
Rgds / Charles.C