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

By Kurt McCauley, R & D Lab Manager

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.

Here we will explore Product D-Value Studies, which are critical to your company developing a Sterilization Process. Find out how best to address what the bioburden of the product is, what effect the product has on the bioburden prior to sterilization, and why performing a D-Value study could be important to your process.