What is bioburden limit of media fill solution before and after filtration…if manufacturing is done in c grade area.
@manojsingh media fill solution should be sterile and should’t have any contamination.
What is bioburden limit before filtration?
10cfu/100 ml as per wfi specification
Media fill shall contain nil bioburden / contamination, it shall be done in grade-A area.inly not in C grade.
If we manufacture media fill in WFI how it is possible nil bioburden while wfi bioburden limit is 10cfu/100 ml
Means before filteration it will be as per WFI limitation,after it will be nil.(you asked for media fill) on that consideration I said nil.
I am agreed with Manoj sir , if we prepare media with WFI it’s 10cfu/ 100ml and in heat sensitive product case NMT 100cfu/ml before filtration.
After filtration media should be sterlie