Bioburden limit before filtration

manojsingh · February 9, 2018, 2:50pm

In case of aseptic filling What is bioburden limit before filtration of bulk solution.

Bharath99 · February 10, 2018, 6:18am

Bioburden limit for media fill before filteran is As per WFI,

manojsingh · February 10, 2018, 1:36pm

Pls provide reference.In schedule M limit is 100 cfu/ml.

manojsingh · February 13, 2018, 5:05pm

As per EMA guideline limit is 10cfu/100ml

Ajay_A · June 5, 2018, 7:49am

100cfu/ml is for PW.