Hyper Rapid Self-contained Biological Indicator for Vaporized Hydrogen Peroxide sterilization processes. Final readout: 5 minutes.
Population | 10^6 Spores/carrier |
---|---|
Read-Out Time | 5 min |
Regulations | IRAM 37102-1:1999, ISO 11138-1:2017, ISO 13485:2016 / NS-EN ISO 13485:2016. |
Field of activity | Healthcare |
Indications for use
Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators have been designed for quick and easy monitoring of Plasma or VaporizedHydrogen Peroxide sterilization cycles. Please review the instructions for use for applicable cycles in your country.
Device description
Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier and a glass ampoule with a culture medium, enclosed with a colored cap.
Each tube contains a population of Geobacillus stearotermophilus ATCC® 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT98 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide.
Precautions
WARNING: Do not use Terragene® Bionova® BT98 SCBI to control EO, Dry Heat, Formaldehyde or other sterilization processes different from specified. Do not reuse SCBI.
WARNING: Place one or more SCBI in sterilizing hard-to-reach areas to ensure all areas of the chamber are sterilized. Please evaluate all load configurations to ensure ALL hard-to-reach areas have been identified, and place a SCBI in each of those locations.
WARNING: Do not reuse the sterilizer until the SCBI test result is negative.