SteraMist BIT is Fully Validated to Comply with Good Manufacturing Practices (cGMP) and Good Laboratory Practice (cGLP) Environments.
Vibraclean’s experts can assist in every step, from a simple validation technique to a Pharmaceutical’s Qualification: requirement of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Validate SteraMist™ Efficacy using the Traditional Chemical Method
Chemical Indicators (CIs) test a decontamination technology is delivering the needed dosage to the area being tested and works with or without the use of a Biological Indicator (BI) or Enzyme Indicator (EI). Chemically treated paper strips used to measure color charted exposure levels. These are packaged with a color chart in a waterproof plastic vial. A CI measures homogenous distribution of TOMI’s BIT Solution. As the aerosol is applied the CIs turn color to the desired log kill.
Validate SteraMist Efficacy using the Traditional Biological Method
TOMI recommends the use of Geobacillus stearothermophilus ribbons for the validation of BIT when using Biological Indicators (BIs). BIs provide evidence that the iHP process conditions are sufficient to kill spores. BIs are accepted universally by several organizations as the “Gold Standard” for monitoring and decontamination and sterilization protocols. TOMI has chosen Geobacillus stearothermophilus as our standard when validating with BIs because it is more resistant than other microbes and provides a safety margin for its customers. Thus, when a TOMI technician has successfully validated a facilities space with BIs, the facility is secured knowing the iHP treatment/service was effective enough to kill a large population of highly resistant spores. Hence, a facility also is secured knowing they received kill on a lower number of less resistant organisms on the surfaces and in the spaces. BIs require a 7-day incubation period for definitive validation.