4h Rapid Self-contained Biological Indicator for EtO SKU: BT110

About 4h Rapid Self-contained Biological Indicator for EtO SKU: BT110

Bionova Rapid Self-contained Biological Indicator Specification

Brand
Bionova

Process
Ethylene Oxide

Packaging
50 indicators per pack

Microorganism
Bacillus atrophaeus ATCC 9372

Population
One million spores per carrier

Readout Time
Four hours

Regulations
IRAM 37102 Part 1, IRAM 37102 Part 2, ISO 11138 Part 1, ISO 11138 Part 2

Length
40 millimeters

Target Market
Healthcare, Pharmaceutical

Description
Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. FDA cleared. Optional visual pH color change can be checked after 48 hours. A 7-day readout is optional for validation of the four hour reading. Fluorescence results may be compared to the 7-day visual reading.

Instructions for Use

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

2. Pack SCBI with materials to be sterilized in areas least accessible to ethylene oxide.

3. Perform sterilization cycle.

4. Wait five minutes after sterilization and remove SCBI using safety glasses and gloves.

5. Check Process Indicator for green color to confirm exposure.

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

7. Incubate processed and positive control indicators in Terragene Bionova Auto-Reader incubator for up to four hours at 37 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.

• If chamber relative humidity is below 35 percent, continue incubation for pH color change as fluorescent readout may be delayed.