Disinfection Qualification

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Disinfectant efficacy and their certification for use in controlled production environments:

The effectiveness and suitability of antimicrobial agents and processes used to eradicate contaminating bacteria and viruses on various surface types and components are formally assessed as part of the disinfection qualification process in an aseptic, sterile, or other carefully controlled manufacturing environment. Disinfectant efficacy testing, which makes use of GLP processes, formally evaluates the acceptability and efficacy of antimicrobial solutions used to eliminate contaminating germs on various surface types and  components. MedWatch Global will collaborate with you to create an efficient cleaning/disinfection schedule for your controlled locations and adheres to USP 1072> disinfectant qualifying methods. In order to produce data to support your procedures, we can test your surfaces using the application techniques and supplies that will be used in your facility against bacteria and viruses that the Sponsor has supplied or that MedWatch Global has obtained. Our studies on disinfection efficacy assess the potency of the disinfectants used in your facilities and give you reliable GLP or cGMP results.

Tests for disinfectant qualification:

  • Qualification of the Disinfectant for Bacteria, Yeast, and Spores
  • Testing for Antiviral Activity in Disinfectants

During the manufacturing process, representative surfaces from the GMP manufacturing facility are injected with test viruses utilized in manufacturing production and any normal viral contamination that the facility has routinely isolated. The surfaces are cleaned with the facility’s regular cleaning methods. Following treatment, surfaces are checked for any lingering viruses using an assay method designed for the test virus. The GMP facility doing the qualification testing chooses the level of reduction deemed necessary for effective disinfection.

  • Qualification for disinfection in the pharmaceutical sector

The effectiveness and suitability of antimicrobial products and processes used to get rid of contaminating microorganisms on various surfaces and items within an aseptic, sterile, or controlled manufacturing environment are assessed by MedWatch Global’s antimicrobial experts using cGMP standards. We follow USP 1072> disinfection qualifying techniques with our all-inclusive disinfection services. Together, you and our advisory team will create a productive cleaning schedule for your regulated industrial environments. Contact us right away to learn more about our services.