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THE PHARMA REVIEW (NOV DEC 2018)

Biological Indicators D-value and Population Verification/Assessment

Russ Nyberg

Introduction:

A large number of end-users of Biological Indicators (BIs) are sending the BIs out to 3rd party laboratories for verification of the D-value and/or population of the BI prior to acceptance for use. Having worked within the biological indicator manufacturing industry for nearly 16 years and through hundreds of personal conversations with end users of BIs in regards to BI verification/assessments, it becomes increasingly clearer to me that some very real confusion exists in relation to 3rd party testing and assessment/verification testing results and what can and can not be done with this data.

 

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