For the Aseptic manufacturing by process validation by media fill, is it necessary to validate the each product configuration by media filling activity, like we have a we have a 4 product in 5ml glass vial which utilizes the same glass vial and F/O seal but rubber stoppers used for all 4 different products rubber stopper are of different type. Is it necessary to prove the media fill with all four types of rubber closure or media fill for one type of rubber closure is sufficient to prove the aseptic filling operation?
Is it your products freeze drying or just aseptic filling, stoppering and crimping? I mean did the stoppers have any splits? If stoppers have not splits then the type of stoppers is not important for media simulation.
It is aseptic filling, and the stoppers used are different types
- Chloro butyl
- Florocoated bromobutyl
- Florocoated gray chlorobutyl
For all above stoppers the manufacturing and filling process is same , is there is need to perform the media fill validation for all these rubber stoppers.
Material stoppers is not exactly the type of stoppers. Type-it is category, which describe geometric dimensions, mass, inner, outer squares and other. In general, all stoppers sterilize before use. So, stoppers cant be source of CFU. You can use anyone stoppers type or mix of all types of it