Description
Ultra Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 20 minutes.
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 20 minute-reading. 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 ºC. Another D-value is informed at 132ºC and at 135ºC. Z-Value is informed.
Instructions for Use
1. Identify the Terragene® Bionova® PLMBT224 SCBI by writing the steriliser 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 sterilising agent (e.g., the center of the load and areas near the door).
3. Sterilise as usual.
4. After the sterilisation process has finished, open the steriliser door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® PLMBT224 SCBI from the sterilised package.
WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.
5. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has 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 sterilisation process.
6. 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 within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator.
IMPORTANT: Use a non-sterilised SCBI as a positive control at least once per day, when a sterilisation 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 Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch.
7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 20 minutes at (60 ± 2) °C for ultra rapid readout.
NOTE: Holding time between sterilisation and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means a failure in the sterilization process. If no fluorescence is detected at 20-minute incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for a visual color change.
