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BI validation

Dear Forum:

USP 24 second supplement <1035> Biological Indicators For Sterilization 
states that the user needs only to observe the D value of the indicator from 
the manufacterers. Although, it also states a a user may elect to do the D 
value determination if they have the capability. My questions are: 1) What is 
the industry standard of verifying the D value of BIs as it stands today? 2) 
What is your opinion of how industry standard will change, if at all, when 
the second supplement becomes effective in July 1?

Any input would be appreciated.

Regards,

Jarrod O'Leary
ecolijoe@aol.com




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