As per USP it is recommended to use Cephalsporinase or penicillinase enzyme in sterility testing of antibiotic but in my case when I used rinsing buffer in memebrane filtration method the effect is also nullify so what’s the point of using enzyme if we rinse membrane with rinsing buffer? I conclude these results on the basis of experiment where I run following set of experiment with routine testing.
Negative control ( Culture+ Antibiotic product)
Positive Control ( Culture+Antibiotic product + Enzyme)
Growth should not be appeared in negative control but I found bacterial growth in both conditions which shows that after rinsing of product the effect of antibiotic is nullify as we perform in case of method suitability testing.( there is no case of contamination)
need your insight in this regard that is enzyme should be used only in direct method or what else?