20min Biological Indicator for Steam SKU: BT224

About 20min Biological Indicator for Steam SKU: BT224

Bionova Ultra Rapid Self-contained Biological Indicator Specification

Brand
Bionova

Process
Steam

Packaging
50 indicators per pack

Microorganism
Geobacillus stearothermophilus ATCC 7953

Population
One million spores per carrier

Readout Time
20 minutes

Regulations
IRAM 37102 Part 1, IRAM 37102 Part 3, ISO 11138, ISO 11138 Part 1, ISO 11138 Part 3

Target Market
Dental, Healthcare, Pharmaceutical

Description
Ultra Rapid Self-contained Biological Indicator for Steam sterilization processes. Final readout in 20 minutes. FDA cleared. Optional visual pH color change can be checked after 48 hours. A 7-day readout is optional for validation purposes. D-Value is not lower than 1.5 minutes at 121 degrees Celsius. Additional D-Values are available at 132 degrees and 135 degrees Celsius. Z-Value is provided.

Instructions for Use

1. Label the SCBI with sterilizer number, load number, and processing date.

2. Place SCBI with the materials to be sterilized in areas least accessible to steam.

3. Perform sterilization cycle.

4. After sterilization, wait five minutes and remove SCBI using safety glasses and gloves.

5. Check Process Indicator for a brown color to confirm exposure to steam.

6. Seal the tube, crush the ampoule, shake to soak the spore carrier, and place in the incubator.

7. Incubate processed and positive control indicators in the Terragene Bionova Auto-Reader incubator for 20 minutes at 60 degrees Celsius. Fluorescence detection indicates sterilization failure. Positive control must give positive fluorescence.

Notes

• Positive control should be used at least once per day.

• Holding time between sterilization and incubation should not exceed seven days.

• Fluorescence detection wavelength is 340 to 380 nanometers excitation and 455 to 465 nanometers emission.