VALIDATE A 6-LOG KILL WITH ONE OR MORE OF THE FOLLOWING METHODS TOMI HAS TO OFFER!
TOMI’s experts can assist in every step, from a simple validation technique to a requirement of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). BIT is Fully Validated to Comply with Good Manufacturing Practices (cGMP) and Good Laboratory Practice (cGLP) Environments.
TOMI recommends the efficacy of the SteraMist technology to be tested using
Chemical Indicators (CIs), Biological Indicators (BIs), and/or Enzyme Indicators (EIs).
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 Indicators (BIs) or Enzyme Indicators (EIs).
Chemically treated paper strips used to measure color charted exposure levels. These are packaged with a color chart in a waterproof plastic vial.
CIs measure homogenous distribution of TOMI's BIT Solution. As the aerosol is applied the CIs turn color to the desired log kill.
TOMI recommends the use of Geobacillus stearothermophilus or Bacillus atrophaeus ribbons with the lowest D-values for the validation of BIT when using Biological Indicators (BIs). TOMI has chosen Geobacillus stearothermophilus or Bacillus atrophaeus as the standard when validating with BIs because it is more resistant than other microbes and provides a safety margin for its customers.
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.
Enzyme indicators (EIs) are an alternative way to validate decontamination performance instantly. EIs are industry-changing advances in measuring H₂O₂ decontamination performance. As Protak's only U.S. supplier, TOMI offers domestic and international customers the option to validate SteraMist technology with advanced Enzyme Indicators (EIs).
A test strip is ejected from its carrier into a reading tube. Results are delivered within 60 seconds. Features a longer indicator shelf life and a reduced treatment turnaround time.
Developed over 15 years by an executive agency of the UK Department of Health.
Manufactured to eliminate rogue results and provide accurate, tamperproof data when compared to conventional BI tests.
Provides performance monitoring, threshold release, and automatic data capture fields such as individual test identifiers, test positions, cycle type and user and equipment I.D.
INSTALLATION, OPERATIONAL, & PERFORMANCE QUALIFICATION
Validate by establishing documented evidence that shows a facility has a high degree of assurance that will consistently yield a product with predetermined quality standards.
TOMI will customize a validation process that meets the needs of any facility, large or small with a variety of budgets. Using one of the methods above, or a combination of all, share what your decontamination goals are and we’ll bring the solution!