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THE PHARMA REVIEW (SEP OCT 2018)

Product D-Value Studies: A Critical Tool When Developing A Sterilization Process

Kurt McCauley

Introduction:

The objective of a sterilization process is to kill the naturally occurring microbial contamination (bioburden) present in the product. Two common sterilization methods used are the Bioburden Based Sterilization (BBS) method and the Overkill Sterilization (OS) method. The BBS method is defined as a sterilization process with parameters based upon the predetermined type and concentration of bioburden on the material being sterilized. The OS method is defined as a sterilization process that is based upon an arbitrarily established higher initial concentration and resistance of bioburden than that actually expected on the material being sterilized.
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