Has Berkshire or a 3rd party performed any microbial efficacy/kill studies on the SatPax® line of presaturated IPA wipers?
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.
These are just some of the variables involved that need to be considered when planning an efficacy study.
- What type of surface are you cleaning? Is it a hard surface or porous?
- What types and numbers of microorganisms are possibly present? IPA is not a sporicidal.
- Class of cleanroom
- Temperature and humidity
- Gowning level
- Sterile vs. non-sterile wipe
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