BT222 STEAM SUPER 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: 1 hs. 60°C. Units per box: 50.
Bionova® BT222 Biological Indicator consists of a plastic tube with a plastic cap with holes and a steam permeable barrier. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores soaked on a paper strip (spores carrier) and a purple color culture medium within a glass ampoule, which is over a filter and the carrier on the base of the tube.
Bionova® BT222 Super Rapid Readout Biological Indicators have been designed quick and easy monitoring of steam sterilization cycles at 121-135 °C.
Super rapid readout: 1 hour
The Super Rapid Readout must be carried out in Bionova® IC10/20FR, Bionova® IC10/20FRLCD or Bionova® MiniBio Reader Incubator, which is capable of performing an early detection of 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 reading of negative results is readily available at 1 hour incubation. It is a direct process 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.
- Polypropylene 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. 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 1 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 1 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.