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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