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May 2006


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孙 冬梅 <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 3 May 2006 01:40:32 +0000
text/plain (65 lines)
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?

Best regards,
Sun Dongmei

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