is it required to discard material like rubber stopper, seal, filter and silicon tubing if sterilization hold period completed successfully after sterilization reset temperature achieved in autoclave cycle or can we use it?
Hello Ayaan and welcome!
What do you mean bby “sterilization reset temperature achieved”? I will assume that you mean that these materials were subject to an incomplete sterilization cycle and, therefore were subject to a subsequent complete sterilization cycle.
If this is the case, then it is very common to discard this type of materials, specially rubber stoppers, but it is not that it is a regulatory requirement per se. The reason for doing this is that most elastomeric materials, like rubber stoppers, can change their characteristics when submitted to high temperatures. For example: almost none of the rubber stoppers can withstand a double sterilization cycle, because the rubber gets sticky and cannot be used, and could potentially create extractables or leachables.
If you have the intention to use these materiales, regardless of this fact, you should demonstrate that these materials keep their critical to quality (CTQ) attributes (also known as Critical Material Attributes, CMA) so that the product’s quality is not being impacted by this.
I hope this helps!
Thank you sir, It is realy helpful