Due to power interruption, sometimes the sterilization cycle of rubber stopper is aborted before completion of the cycle. Then re sterilization need to be done. In that case, what type of test & documentation will be needed to support the process?
You have to analyze this with a risk based approach.
One of the risks that you have to mitigate when re-sterilizing stoppers, is that these rubber stoppers, like any other plastic or rubber material, is most likely going to impact on extractables or leachables that could impact the safety of the product. Additionally, they tend to get sticky and become really hard to handle during operation, and if used for aseptic process, this can increase the number of interventions.
If you truelly want to use these stoppers that are being re-sterilized, you would have to test it at least for extractables or leachables, and functionality of the stopper (i.e. handling and CCIT tests), in a way similar as you would do for stability studies.
In my opinion, coming from experience, it is much more easier to solve your power outage problem in your autoclave, than making these studies, so that you dont have to re-sterilize these stoppers in the first place. From a risk management perspective, this is likely to be also the “safest” approach, because you will be dealing with the root cause of the problem, instead of normalize it as part of your process routine.
I hope this is helpful.