- Rapid Readout:
- Achieves a rapid readout in just 2 hours at 60 °C, providing quick and efficient results.
- Fluorescence Detection:
- Excitation 340-380 nm / emission 455-465 nm. Lack of fluorescence after 30 minutes indicates sterilization success; positive fluorescence means sterilization failure.
- Positive Control:
- A positive control must yield positive fluorescence readout, and it is recommended to incubate it for visual color change.
- Visual Confirmation (Optional):
- After 48 hours, a visual pH color change can be performed. Yellow indicates sterilization failure, while purple confirms success.
- Incubation Conditions:
- If the 7-day readout is performed, a humidified environment is necessary to prevent medium drying out. The holding time between sterilization and incubation should not exceed 7 days.
Important Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection indicates sterilization failure, and a positive control is crucial for validation.
Instructions for Use:1. Identify the Biological Indicators 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 which are considered most inaccessible for the sterilizing agent
(e.g., the center of the load and areas near the door).
3. Sterilize as usual.
4. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the Biological Indicators from the package.
CAUTION: Wear safety glasses and gloves when removing the 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. Let the Biological Indicator cool down until it reaches room temperature.
5. Check the Process Indicator on Biological Indicator label. A color change to green indicates that the Biological Indicator has been exposed to Hydrogen Peroxide.
IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process.
6. Press the lid 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 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 Biological Indicator in the incubator.
IMPORTANT: Use a non-sterilized Biological Indicator 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; the capability of the 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 30 minutes at (60 ± 2) °C for super rapid readout.
Precautions WARNING:
Do not use Biological Indicator to control EO, Dry Heat, Formaldehyde or other sterilization processes different from the specified.
Do not reuse Biological Indicator
WARNING:
Place one or more Biological Indicator in sterilizing hard-to-reach areas to ensure all areas of the chamber are sterilized.
Please evaluate all load configurations to ensure ALL hard-to-reach areas have been identified, and place a Biological Indicator in each of those locations.
Do not reuse the sterilizer until the Biological Indicator test result is negative.
