BT224 STEAM ULTRA RAPID
Self-Contained Biological Indicator. Ultra Rapid Readout Fluorescence System Monitoring vacuum assisted and gravity air-displacement Steam sterilization cycles at 132-135ºC.
Spore: Geobacillus stearothermophilus (ATCC 7953). in a 106 population.
Applicable regulations: IRAM 37102-1:1999, IRAM 37102-3:1999, ISO 11138-1:2006, ISO 11138-3:2006. Incubation conditions: 20 min. 60ºC. Units per box: 50
Terragene® Bionova® BT224 Ultra Rapid Readout Biological Indicator for Steam sterilization processes has been designed for quick and easy monitoring of vacuum assisted and gravity displacement Steam sterilization cycles at 132-135ºC.
Each indicator consists of a plastic tube, a special filter, a spore’s carrier (filter paper strip) soaked with Geobacillus stearothermophilus ATCC 7953 bacterial spores and a glass ampoule. The ampoule contains a purple colored culture medium, specially formulated to promote growth of surviving spores. The tube is sealed by a plastic cap with holes and a Steam permeable barrier.
Ultra Rapid Readout: 20 minutes
The Ultra Rapid Readout must be carried out in the Terragene® Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Reader Incubators. Fluorescence is produced when the reader stimulates the carrier with UV light. Final readout of negative results is readily available after 20 minutes of incubation. Fluorescence is a direct measure of the germination and growth of Geobacillus stearothermophilus spores which have survived the
sterilization process (positive result). Furthermore, a failure in the
sterilization process can also become evident by the color change of the medium. Due to the high sensitivity of the fluorescence results at 20 minutes, conventional incubation for color change of Terragene® Bionova® BT224 Ultra
- Polypropylene tube: 50.5 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm
- Special filter: 17mm of external diameter polypropylene microfibers.
- Polypropylene cap: 10.5 mm external diameter, 16.5 mm high. Wall thickness: 1.0 mm
- Glass ampoule: 38.0 – 40.0 mm high. mm. External diameter: 6.5 mm.
Culture medium 0.65 – 0.75 ml, purple color.
- Cap filter: medical grade paper, 60 g/m2 , 17.0 mm diameter.
- Carrier filter paper: 5.0 x 25.0 mm, 160 g/m2. ? 106 Geobacillus stearothermophilus ATCC 7953 spores per vial. Final fluorescence reading is performed after 20 minutes-incubation at 60 ºC (sensitivity: 97 %).
An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization
process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 20 minutes-reading. Fluorescence results
may be compared to the 7-day visual reading.
- NOTE: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out.
- D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132ºC y a 135ºC.
- Z-Value: Not lower than 6 ºC.