Photon Self-Contained Biological Indicator (SCBI) for Steam sterilization processes. Geobacillus stearothermophilus (ATCC® 7953, ATCC is a registered trademark of American Type Culture Collection) 10^6 spores per vial. Readout: 7 seconds.

FDA granted

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 °C, 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 7-seconds readout. Fluorescence results may be compared to the 7-day visual reading.
NOTE: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out.

D-Value: Not lower than 1.5 minutes at 121 °C. Another D-value is informed at 132 °C and at 135 °C.

Z-Value is informed

Instructions for Use

1. Identify the Bionova® BT225 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label.

2. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door).

3. Perform sterilization cycle.

4. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Bionova® BT225 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst.

5. Let the SCBI cool down until it reaches room temperature.

6. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBIhas been exposed to Steam. IMPORTANT: this color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process.
7. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed at the rear of the Bionova® Photon® Auto-reader Incubator (BPH). Then shake the tube down vigorously, until the medium reaches the base of the tube and soaks the spore carrier entirely. Incomplete wetting of the spore carrier may lead to an incorrect fluorescence readout. Finally, place the SCBI in the incubator.IMPORTANT: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; capability of medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of the Auto-reader incubator. Both, the positive control indicator and the processed indicator, should belong to the same batch.8. Incubate the processed biological indicator and the positive control indicator in the Bionova® Photon® BPH Auto-reader incubator for 7 seconds at (60 ± 2) °C for instant readout. NOTE: Holding time between sterilization and incubation should not exceed a 7-day period. The fluorescence intensity detected by the auto-reader (excitation 340-380 nm / emission 455-465 nm) after 7 seconds of incubation determines the efficiency of the sterilization process. It is good practice to incubate a positive control for a visual color change.Record the positive results and discard the SCBIs immediately, as it is indicated below.