BT96 VH202 SUPER RAPID
Self-Contained Biological Indicator. Super Rapid Readout Fluorescence System for monitoring plasma or vaporized Hydrogen Peroxide sterilization processes (VH2O2).
Each tube contains a population of Geobacillus stearotermophilus ATCC 7953
spores inoculated on a strip (spores carrier). It also has a purple colored
culture media contained within the glass ampoule, next to the carrier, on the
base of the tube.
Bionova® BT96 Super Rapid Readout Biological Indicators have been
designed for quick and easy monitoring of Plasma or Vaporized Hydrogen
Peroxide sterilization cycles. They consist of a plastic tube, a spore carrier and
a glass ampoule with a culture medium. The tube has a plastic top with holes
and a barrier permeable to Hydrogen Peroxide.
Super Rapid Readout: 30 minutes
The Super Rapid Readout must be carried out in the Bionova® IC10/20FR,
IC10/20FRLCD or MiniBio Reader Incubator or in a similar Reader Incubator
that meets the features that are described below. 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 excites the carrier with UV light at 360 nm. Final
readout of negative results is readily available at 30 minutes of incubation.
Fluorescence 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 culture media. Due to the high
sensitivity of the fluorescence results after 30 minutes, conventional
incubation for color change of Bionova® BT96 Biological Indicator is not an
- 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: 3.8 – 40.0 mm high. mm. External diameter: 6.5 mm. Wall thickness: 0.2 – 0.3 mm.
- Culture medium 0.65 – 0.75 ml, purple color.
- Cap filter: polyethylene fibers, 160 g/m2, 16.0 mm diameter.
- Polyethylene fibers: 5.0 x 40.0 mm, 160 g/m2. ? 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
- Final fluorescence reading is performed after 30-minute incubation at
60 ºC (sensitivity: 97 %).
- An optional visual pH color change confirmation could be performed
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
- 7-day readout is optional and not intended to be routinely performed; it
is an initial validation of the 30-minute reading. Fluorescence results
may be compared to the 7-day visual reading.