A critical tool for sterilization cycle development: Product D-value Studies

Learn when and how you should perform a D-value study on your product

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Pharma IQ
Pharma IQ
06/07/2022

Spores in petri dish

The objective of a sterilization process is to kill the naturally occurring microbial contamination (bioburden) present in a product.

These microorganisms can be viral, bacterial or fungal. Typically, they come from three main sources: the manufacturing environment, personnel and raw materials including water. It is essential to learn as much as possible about the bioburden organisms in order to perform sterilization adequately.

The most direct method for evaluating the test organism is by performing a D-value study. This white paper from Mesa Labs explains how these should be carried out.

Download this white paper now to find out:

  • How to characterize the bioburden of a product
  • The types of spores sterilization cycles can be based on  
  • How D-value studies are performed and their advantages
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