Disinfectant Testing and Validation

A controlled manufacturing cleanroom environment requires a sound disinfectant testing program. Disinfectants utilized in routine cleaning 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.
Why should I choose Microtest Laboratories to perform my disinfectant validation study?
  • Microtest is a high-quality laboratory that 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.
  • Microtest 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 the actual surfaces present in the client's clean room environment.
  • The disinfectants are sprayed on the surfaces using the method and contact time that are 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.
Microtest can create a proposal for your disinfectant validation study with the following information:
  • Quantity of surface materials found in your facility
  • Quantity of environmental isolates/ATCC strains to be utilized in study
  • Quantity of disinfectants to be challenged against in study
  • Quantity of time-points to be challenged in the study (time disinfectant sits on a given surface)

1 comment:

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