Disinfectant Qualification

A controlled manufacturing cleanroom environment requires a sound disinfectant qualification program. Disinfectants utilized within these environments must be validated to confirm their effectiveness for use. Proper rotation of the disinfectants can be determined based on the data collected in this study.  Avista Pharma is your capable, dependable partner for performing disinfectant qualifications.


Some common questions and issues regarding disinfectant qualification include:


Why should I choose Avista Pharma to perform my disinfectant qualification study?

  • Avista Pharma has been performing microbiological work for more than 25 years
  • Our specialized microbiology group possesses years of experience performing qualification work on many different surface types using a wide range of disinfectants
  • Avista has an internal collection of ATCC organisms ready for use onsite, plus the ability to identify and cryopreserve client environmental isolates

How do I know which method to follow for my disinfectant testing study? Tube Dilution Method

  • For clients with new facilities with little or no environmental trending history
  • Utilizes ATCC strains and some environmental isolates, where applicable
  • Isolates are directly inoculated into the desired concentration of disinfectant being tested
  • Studies of this sort allow a facility to begin production with some assurance that their disinfectants can kill specific microorganisms of concern
  • Initial screening of disinfectants does not validate that they are effective on hard surfaces

Coupon Testing Using the Swab Recovery Method

  • For established facilities with environmental programs and trending
  • Coupons are prepared from representative surfaces present in the client’s clean room environment
  • The disinfectants are sprayed on the surfaces using the method and contact time captured in the client’s cleaning procedures
  • To ensure implementation of a proper disinfection program, the FDA recommends the use of the facility’s environmental isolates. However ATCC organisms may be used as well

Avista Pharma can create a proposal for your disinfectant qualification study with the following information:

  • Quantity of surface materials found in your facility to be used in the study
  • Quantity of environmental isolates/ATCC strains to be used in the study
  • Quantity of disinfectants to be challenged in study
  • Quantity of exposure time-points to be challenged in the study (time disinfectant sits on a given surface)