BT102 FORM RAPID
Rapid readout fluorescence system. Self-contained biological indicator for Formaldehyde sterilization processes
Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores soaked on a strip (spores carrier). It also has purple colored culture medium contained within the glass ampoule, next to the carrier, on the base of the tube.
Bionova® BT102 Rapid Readout Biological Indicators have been designed for fast and easy monitoring of Formaldehyde sterilization cycles. They consist of a plastic tube, a spore carrier and a glass ampoule with culture medium. The tube has a plastic top with holes and a barrier permeable to Formaldehyde.
Rapid readout: 2 hours
The rapid readout must be carried out in the Bionova® IC10/20FR 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 spore carrier. Fluorescence is produced when the reader excites the carrier with UV light at 360 nm. Final reading of negative results is readily available at 2 hours 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.
- Polypropylene random copolymer tube: 50.0 mm high x 8.5 mm
external diameter. Wall thickness: 0.5 mm
- 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.
- Polyethylene fibers: 5.0 x 20.0 mm, 160 g/m2.? 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
- Final fluorescence reading is performed at 2 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 2 hour-reading. Fluorescence results may
be compared to the 7-day visual reading.