2h Biological Indicator for LTSF

BT102 / Rapid Self-contained Biological Indicator for Formaldehyde sterilization processes. Geobacillus stearothermophilus (ATCC® 7953) 10^6 spores per vial. Readout: 2 hours.

Characteristics

Polypropylene tube: 50.7 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm.

Polypropylene cap: 16.4 mm high x 10.7 mm external diameter. Wall thickness: 0.9 mm.

Cap filter: polyethylene fibers, 17.0 mm diameter.

Glass ampoule: 35.0 – 40.0 mm high. mm. External diameter: 6.8 mm.

Wall thickness: 0.2 – 0.3 mm.

Culture medium 0.5 – 0.7 ml, purple color.

Polypropylene microfiber on spore carrier, 17.0 mm diameter.

Spores carrier: polyethylene fibers, 17.0 mm of diameter. 10^6 Geobacillus stearothermophilus ATCC® 7953 spores per vial.

Instructions for use

1. Identify the Bionova® BT102 Biological Indicator by writing the sterilizer number (in case of having more than one), load number and processing date on the label.

2. Pack the biological indicator along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas considered a priori most inaccessible for the sterilizing agent (Formaldehyde). Generally, the center of the load and areas near the door are more problematic.

3. Sterilize as usual.

4. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the biological indicator from the package. CAUTION: Wear safety glasses and gloves when removing the Bionova® BT102 Biological Indicator from the sterilized package.

WARNING: Do not crush or handle the biological indicator excessively, since this might cause the glass ampoule to burst.

5. Let the biological indicator cool down until it reaches room temperature.

6. Check the chemical indicator on the label of the biological indicator. A color change to green indicates that the biological indicator has been exposed to Formaldehyde.

IMPORTANT: this color change does not evidence the process effectiveness to achieve sterility. If the chemical indicator color has not changed, check the sterilization process.

7. Press the cap to seal the tube. Crush the ampoule contained in the biological indicator with an individual ampoule crusher or with the ampoule crusher placed within the top of the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature of a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the biological indicator in the incubator.