Is it required to periodically CCI test the media filled ophthalmic dropper tip bottles (filled with tryptic soy broth media) during filling on aseptic production machine using a physical CCI test method e.g. Vacuum decay tester ,
Or it is sufficient to test samples of the produced batch of these media filled ophthalmic dropper tip bottles using microbial ingress CCI test ?
(The importance of the question arises from the potential difficulty of testing media filled bottles using vacuum decay method because the peptides of the media might clog the bottle defect thus reducing vacuum decay method sensitivity when testing the media filled ophthalmic bottles compared to its sensitivity when testing product filled ophthalmic bottles)
And in case of necessity to periodically CCI test the media filled ophthalmic dropper tip bottles: will it be appropriate to stop media filling periodically so as to produce empty ophthalmic bottles periodically so as to avoid the potential bottle defect clogging problem caused by media peptides if such problem happened ?