5min Biological Indicator for Hydrogen Peroxide – Hyper
Hyper Rapid Self-contained Biological Indicator for Vaporized Hydrogen Peroxide sterilization processes. Final readout: 5 minutes.
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.
Hyper rapid readout: 5 minutes
The hyper rapid readout must be carried out in the appropriate Terragene® Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the spore carrier with UV light. Final readout of negative results is readily available after 5 minutes of incubation.
Fluorescence readout is an indirect measure of the viability of Geobacillus stearothermophilus spores after the sterilization process (positive results). Furthermore, a failure in the sterilization process can also become evident by culture medium color-change. Due to the high sensitivity of the fluorescence results at 5 minutes, conventional incubation for color change of Terragene® Bionova® SCBI BT98 is not an advantage.
Visual confirmation: 5 days
Optionally, you can perform a visual color-change confirmation after a 5-day incubation. If the sterilization process has not been successful, culture medium will turn to yellow during incubation at (60 ± 2) ºC, indicating the presence of living spores.
If sterilization was successful, culture medium will remain purple after incubation. The positive control must show a color change from purple to yellow for results to be valid. NOTE: If 5-day readout is performed, a humidified environment will be required to prevent medium from drying out.
Readout time: 7 days
A 7-day readout is optional and may be routinely performed. This is an initial validation of the 5-minute readout. Fluorescence results are compared to the 7-day visual readouts. NOTE: If 7-day readout is performed, a humidified environment will be required to prevent medium from drying out.
Monitoring frequency
Follow facility policies and procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As the best practice and to provide optimal patient safety, Terragene® recommends that every sterilization load be monitored with an appropriate biological indicator.
Storage
Store in a dark place at temperature between 10-30 ºC and 30-80 % relative humidity. Do not freeze. Do not store biological indicators near sterilizing agents or other chemical products.
Disposal
Discard biological indicators after use according to your country’s healthcare and safety regulations. The positive biological indicators can be autoclaved in a gravity air displacement steam sterilizer at 121 ºC for 5 minutes, 132 ºC for 15 minutes or 134 ºC for 10 minutes; or in a dynamic air removal steam sterilizer at 132 °C for 4 minutes or 135 °C for 3 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. |