USP Microbial Limits Prep Test

dwimmer at smartnet.net dwimmer at smartnet.net
Tue Nov 21 21:03:44 EST 1995


<prior articles snipped out as the server would not take so much quotes!>
Enigl wrote:

> I wrote an SOP covering the process of Microbial Limit Tests validation...
<snip>

Question 1: How long does it take for you to validate each material (hours)?
Question 2: Why not start with filtration? If you go by the easiest route to 
validate, then all materials are tested the same, simplifying procedures.
Question 3: What kind of materials are you routinely testing? 
Question 4: What do you do with antibiotic raw materials which are to be tested?

I would be very interested in your response, as well as anyone else running Microbial 
Limits tests. Thanks



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