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May 2006


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Jill Blythe <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 30 May 2006 10:27:25 -0500
text/plain (51 lines)
In light of the harmonized microbial methods that I believe were signed 
off on in November, 2005, what are the thoughts out there on pH 
adjustments of the sample dilution to between 6-8?  Is it necessary to 
make the pH adjustment if we can show by dilution or neutralization, 
recovery of all the challenge microorganisms?

Also, if during validation, a pH adjustment is necessary, how close to 
the pH obtained during validation would one have to be for routine 
testing? Plus or minus 0.2 pH units or just between 6-8?

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