In-use limit for parenteral preparation

Have a good day.
I would like to ask about in use test for parenteral preparation (sterile eye drop),
Shall I perform sterility test at the initial of in use test (the limit should be sterile),and I perform the Microbial Limit Test (MLT) at the end of in use test.
What the limit for MLT at the end of in use test ?


Sterility test is a compulsary release test. What in-use testing you should do depends on the claim you make about microbial quality of the product at the end of the in use period. If you claim that the product remains sterile while in use, perform sterility test. If not, perform enumeration test combined with preservative efficacy test (PET). The dropper and the residual eye drop are to be examined for contamination, the number of colonies counted, identified and PET to selected antimicrobial agents is to be done. Limit is based on results of PET.