I have to qualify a new production line of ampoulles with terminal sterilization.
My question is that provided that the ampoulles are sterilized terminally, is it necessary to do media fill runs as a part of PQ qualification?.
Thank you very much.
You have to qualify your Filling lines with Media Fills to identify how good your line is. This gives a basic idea how contaminated your lines are. As far as GMP is concerned the line must comply all the Sterility Assurance rules when you manufacture as Sterile product.
A terminal sterilization is only for the product that cannot be sterilized by conventional methods or it is more economical by terminal sterilization.
You have primary packing materials that come out of sterilization normally.
There is every need to qualify your lines with Media fill runs.
3 times . No exception in your case.
Regards
I’m not sure… as far as I know, media fill is aseptic process validation, when no terminal sterilization (using heat or radiation) process applied. aseptic processing is a process being operated in a controlled (not sterile) environment. without sterilization in the end of process, manufacturer need to ensure that the products are sterile during process. it needs large amount of samples. that’s why media fill as process simulation is required.
beside mimicking the ideal condition (strictly controlled), media fill could also be challenged using worst case scenario, that may be occurred during the real process.