SteraMist BIT is Fully Validated to Comply with Good Manufacturing Practices (cGMP) and Good Laboratory Practice (cGLP) Environments
A TOMI technician is available to work through many decontamination validation processes. 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 Pharmaceutical’s Qualification: requirement of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
TOMI recommends the efficacy of the SteraMist technology to be empirically tested using Chemical Indicators (CIs), Biological Indicators (BIs), and/or Enzyme Indicators (EIs) to ensure a 6-log kill.
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.
Validate SteraMist Efficacy using the Revolutionary EI Method
Enzyme indicators (EIs) are an alternative way to validate decontamination performance instantly. This new science technology could potentially change the world of validation! EIs are industry-changing advances in measuring H₂O₂ decontamination performance. Adenylate kinase is an enzyme; its presence and activity can be measured using a rapid and sensitive luminescence assay. It originated from the isolation of thermostable Adenylate Kinase (tAK) from thermophilic bacteria found in hot springs (Sulpholobus acidocaldarius).
The advantage of EIs is that they report results at the highest log kill available in science and in 60 seconds or less! Instant results mean instant action to increase productivity for any facility.
Does your facility require specific qualifications?
Validation executed as a regular exercise is a method of establishing documented evidence that shows a facility has a high degree of assurance that processes will consistently yield a product with predetermined quality standards.
A SteraMist technician may 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!