Bioburden limit of media fill solution

manojsingh · January 27, 2018, 6:05pm

What is bioburden limit of media fill solution before and after filtration…if manufacturing is done in c grade area.

Ankur · January 29, 2018, 4:48am

@manojsingh media fill solution should be sterile and should’t have any contamination.

manojsingh · January 29, 2018, 1:33pm

What is bioburden limit before filtration?

manojsingh · January 31, 2018, 2:49pm

10cfu/100 ml as per wfi specification

Bharath99 · February 9, 2018, 5:07pm

Media fill shall contain nil bioburden / contamination, it shall be done in grade-A area.inly not in C grade.

manojsingh · February 9, 2018, 6:35pm

If we manufacture media fill in WFI how it is possible nil bioburden while wfi bioburden limit is 10cfu/100 ml

Bharath99 · February 10, 2018, 6:21am

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.

Rakesh · August 25, 2019, 5:07pm

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