Disinfectant Validation Studies

Expertise & Commitment

Disinfectant Validation Studies are a critical group of microbiological tests to demonstrate the efficacy of disinfectant products and the cleaning process employed in your facility. The test design is custom to your chosen disinfectant(s), application method, contact time, surface materials, and relevant microbes (bacteria, yeast & mold, viruses, etc.).

Your chosen disinfectant product(s) have efficacy claims that meet EPA regulations. However, the FDA requires that cleaning of all manufacturing areas and clean rooms demonstrate that residues and contaminants are properly removed from surfaces in your facility, under your operating procedures.  A new disinfectant validation study is required anytime there is a cleaning product change, change in product ingredient or a significant change in process or frequency of cleaning. For reference see FDA's Validation of Cleaning Processes (7/93).

Our team collaborates closely with yours to design and run an appropriate study to meet FDA requirements. Key elements of the study include:

  • Define study protocols to detail the exact methods during testing under GLP guidelines
  • Gather materials and disinfectants unique to your processes and facility
  • Perform microbiological testing on a range of both antimicrobial and antiviral surface efficacy (In Vitro, time kill and coupon) referencing a large in-house library of organisms readily available for testing (bacteria, viruses, mycoplasma, and environmental isolates).
  • Deliver results and review through QAU to ensure data integrity and quality

Microbac has over 30 years of experience and numerous FDA validation submissions to help design the right study for you under cGMP, GLP and ISO accreditations. Our commitment to quality, service and turnaround stands us apart to ensure compliance and to mitigate brand risk.