Dear team members,
I have some questions about sterility test:
1. If the quantity of a freeze-dry product is 62.5mg, how many containers
should be tested in sterility test according to USP. 20 containers or 40
2. How many batches should be validated in sterility validation? One batch
or three batches.
If one bath is to be validated, how many containers should be tested
If three batches are to be validated, how many containers should be tested
3. Can sterilized WFI be used as dilution and rinse fluid or the dilution
and rinse fluid must follow compendia?
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