Question:

Has Berkshire or a 3rd party performed any microbial efficacy/kill studies on the SatPax® line of presaturated IPA wipers?

 

Answer:

An efficacy/kill study has not been performed by Berkshire or a 3rd party lab for SatPax®.  Because of the number of variables involved when using wipes, it would be very difficult to produce meaningful data. FDA regulated end-users should have a documented cleaning and disinfection protocol as well as a documented cleaning validation process. A cleaning validation process will determine the efficacy of the cleaning and disinfection.

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These are just some of the variables involved that need to be considered when planning an efficacy study.

 

  1. What type of surface are you cleaning? Is it a hard surface or porous?
  2. What types and numbers of microorganisms are possibly present? IPA is not a sporicidal.
  3. Class of cleanroom
  4. Temperature and humidity
  5. Gowning level
  6. Sterile vs. non-sterile wipe

 Have additional questions? Contact us today!