White Paper

Disinfection Qualification

Obtaining the highest confidence that critical manufacturing environments are properly cleaned, sanitized and disinfected is paramount to ensuring the production of safe pharmaceutical products and medical devices.

The microbiological risk of these products is primarily determined by the quality of raw materials, the integrity of the manufacturing process, as well as the effectiveness of cleaning and disinfection procedures performed in the facility. It is for this reason that the U.S. Food and Drug Administration (FDA) requires manufacturers of pharmaceutical and other critical products to qualify and validate the disinfection procedures used in these manufacturing environments.

This paper provides an overview of disinfection qualification testing and the considerations that must be addressed when designing and executing these studies.

Disinfection Qualification includes guidance on

  • The importance of disinfection qualification
  • FDA requirements
  • Scope of qualification testing
  • Study timing and study design overview

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