Calm Logic
Explorer
What classification of clean room is your setup using? That has consistently been the sticking point when it comes to filtering, and it still is today, even with group sterility testing now being a fairly routine alternative (notwithstanding variability within a batch).RetCurious said:
If you filter right away once reconstitution is done, there wouldn't be much time for dead bacteria remnants to form, as far as I can tell. Is there something I'm overlooking here?
(And even having a costly cleanroom did not prevent ProRx from being shut down by the FDA over careless operations.)