Pure steam validation

Microbiology
1

we have to do pure steam validation i wanted to know microbiology testing for pure steam .do we have do BET only are there altanatives ?

2

Yes fern you have to perform

  • total microbial count (with filtration method) in 200ml or 100ml ( calculate the result for 100ml)
  • perform BET max. limit is same with WFI 0.25EU/ml
3

Thanks Gokay.ours is a non sterile plant we do not do BET.Is it ok if i only do total microbial count for the validation?plz advice

4

If your products have endotoxin limit, you have to perform endotoxin test on clean steam.

You have to follow your cs endotoxin because if your drugs are out of limit you have to explain it why?

It can be because of the wfi, it can be because of the raw material or it can be because of the sterilization process ( here is the clean steam endotoxin test importance )

If you dont have any bacterial endotoxin test on your products its not necessary to perform bet validation on clean steam.

Its my opinion please read the guides like iso to be sure about that.

5

Thanx Gokay for your advice