BT220 STEAM RAPID
Spore: Geobacillus stearothermophilus (ATCC 7953). in a 105 or 106 population.
Applicable regulations: IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3.
Incubation conditions: 3 hs. 60°C. Final reading: 3 hs. Units per box: 50.
Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores soaked on a filter paper strip (spores carrier). It also has purple colored culture medium contained within the glass ampoule, over the filter next to the carrier, on the base of the tube.
Product description Bionova® BT220 Rapid Readout Fluorescence System Biological Indicators for Steam sterilization processes have been designed for quick and easy monitoring of vacuum-assisted and gravity displacement steam sterilization cycles at 121-135 ºC. They consist of a plastic tube, a special filter, a spores carrier and a glass ampoule with culture medium. The tube has a plastic cap with holes and a barrier permeable to steam.
Rapid readout: 3 hours
The rapid readout must be carried out in the Bionova® IC10/20FR, Bionova® IC10/20FRLCD o Bionova® MiniBio Reader Incubator or in a similar reader incubator that meets the features that are described next.
The Reader-incubator must be capable of reading the fluorescence emission of the product, resulting from breaking a specific substrate on the spores carrier. Fluorescence is produced when the reader stimulates the carrier with UV light at 360 nm. Final readout of negative results is readily available after 3 hours 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 3 hours, conventional incubation for color change of BT220 Rapid Readout Fluorescence System Indicator is not an advantage.
- Polypropylene random copolymer tube: 50.0 mm high x 8.5 mm
external diameter. Wall thickness: 0.5 mm
Polypropylene microfiber cap at the bottom of the tube.
- Polypropylene cap: 10.5 mm external diameter, 16.5 mm high. Wall
thickness: 1.0 mm
- Glass ampoule: 35.0 – 38.0 mm high. mm. External diameter: 6.5 mm.
- Wall thickness: 0.2 – 0.3 mm. Culture medium 0.5 – 0.7 ml, purple color.
- Cap filter: medical grade paper, 60 g/m2, 16.0 mm diameter.
Spores carrier: Filter Paper: 5.0 x 20.0 mm, 160 g/m2.? 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
Final fluorescence reading is performed after 3 hour-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 a greenish color first, and
then 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 3 hour-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 135ºC.
- Z-Value: Not lower than 6 ºC