Article

Supplier and End-User Disinfectant Qualification Comparison for Cleanrooms

In this article, we compare the methods utilized by a disinfecting agent manufacturer and a pharmaceutical manufacturer to characterize these disinfecting agents and outline some of their respective challenges to help understand expectations and avoid pitfalls.
August 1, 2022

Key Takeaways:

  • Manufacturers register disinfectants, while end-users validate real-world efficacy.
  • EPA and REACH require disinfectants to meet microbial reduction standards.
  • End-users must test efficacy on facility surfaces and environmental isolates.
  • Surface type, contact time, temperature, water quality and microbial load impact qualification.
  • A risk-based, data-driven approach is essential for effective cleanroom contamination control. 

Disinfectants are a critical element in cleanroom contamination control and must be well-suited for the applications for which they are intended. Disinfectants should be tested both during development and registration to ensure proper selection and use. Subsequently, they should be tested by the end-user to ensure that the disinfectant is appropriate for the intended purpose within a specific facility.

Testing a disinfecting agent during product development can differ greatly from the testing required by the end-user to validate a finished formula. Different challenges exist for both developmental testing and effectiveness validation testing that must be understood. This idea is true for all types of disinfecting agents, including those defined as sanitizers, general disinfectants, sporicides, and sterilants.

In this article, we compare the methods utilized by a disinfecting agent manufacturer and a pharmaceutical manufacturer to characterize these disinfecting agents and outline some of their respective challenges to help understand expectations and avoid pitfalls.

Read the Article

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