Aseptic Cleaning, Cleaning & Disinfection, Knowledge Base

Has Berkshire or a 3rd Party Performed Any Microbial Efficacy/kill Studies on the Satpax® Line of Presaturated IPA Wipers?

Posted on by Berkshire Corporation
Satpax Canister
18
Apr

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.

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!

Leave a Reply