I am working in a dry powder injectable facility.We have validated the rubber
stoppers for 72 hrs.My question is whether validity period of rubber stoppers is
being considered according to the cycle run or till door of autoclave has not been
opened i.e till cycle end
Technically speaking any Moist heat sterilized primary packing material should not be used after 24 hours. It also means that this has to be processed with in 24 hours of sterilization.It also means that once the sterilization cycle is completed or finished as per standard cycle format the count down starts.
You cannot keep in an Moist heat sterilizer for 24 hours , later remove it and use with in next 24 hours.
All folks working in a GMP envirionment which is guided by principles of Quality and Assurance must think about water for Injection; FDA proposed 24 hour dump rule. That means the water which is produced by multiple distillation must be discarded from WFI holding tank that is present next to the Multiple Distillation still. If such a rule is existant --Do you have any reason why should we use a Stopper for vials which are Sterilized by moist heat with the same quality of Pure steam that is producing water for Injection?
In my view : Even if you validate the hold time for more than 24 hours, its always good for your industry and keeping in view patient and safety compliance try to process such key and sensitive materials in your core production area with in 24 hours after Sterilization.
Thanks for such valuable information…