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BT40/6 / Spore Strips Biological Indicator for Ethylene Oxide and Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per strip.The envelope containing Bionova® BT40 Spore Strip is specifically designed for the monitoring of Ethylene Oxide (EO) sterilization processes or for Dry Heat sterilization processes.Spore strips should be incubated in Bionova® MC1030-2, Bionova® MC1020-2 Growth Medium tube or in appropriate growth medium for Bacillus atrophaeus ATCC 9372 growth. If the sterilization process was not successful, Bionova® MC1030-2 or Bionova® MC1020-2 growth medium will turn to yellow after incubation at 37±2 ºC, thus indicating the existence of living Bacillus atrophaeus spores on the strip.If the sterilization process was successful, MC1030-2 or MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 48 hours of growth medium incubation at 37±2 ºC.Instructions for use1. Identify Bionova® BT40 envelope by writing on its back the sterilizer number (in case of having more than one), load number and processing date.2. Pack it in appropriate package along with material to be sterilized, according to recommended sterilization practices. Place the envelope in those areas you a priori consider more inaccessible for sterilizing agent. A typical problematic area is the load center.3. Sterilize as usual.4. After the sterilization process has finished, you can:A. Remove the Bionova® BT40 envelope from the package for processing and incubation.B. For Ethylene Oxide sterilization, you can aerate the package containing the biological indicator with the rest of the load or remove the biological indicator from the sterilization package for incubation in MC1030-2, MC1020-2 culture medium or any other appropriate growth medium prior to material aeration.5. Tear up the envelope at one end very carefully under sterility conditions (eg. laminar flow cabinet) and transfer spore strip with a sterile clamp to MC1030-2, MC1020-2 Growth Medium tube, or to any other appropriate growth medium.IMPORTANT! Use latex gloves and chin strap when transferring spore strips from the envelope to growth medium tube. WARNING! Avoid spore strip contact with any kind of surface including the outer part of growth medium tube and of Bionova® BT40 envelope.IMPORTANT: Use a non-sterilized spore strip as a positive control at least once per day, when a sterilization cycle is run. Both, processed spore strip and the strip used as positive control must belong to the same batch. Positive control guarantees that the incubation was carried out under appropriate conditions.6. Incubate processed spore strips along with the strip used as positive control during a maximum of 48 hours at 37±2 ºC. It is advisable to make observations every 10 hours. Color change of MC1030-2 or MC1020-2 Growth medium to yellow means a failure on sterilization process.If after 48 hours no colour change is visible on MC1030-2 or MC1020-2 Growth Medium, the result is negative (i.e. the sterilization process was successful). MC1030-2 or MC1020-2 Indicating Medium used for incubating the spores strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.

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Country Manufacturer : China

BT20 / Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^5 or 10^6 spores per vial. Readout: 24 hours.Monitoring vacuum-assisted and gravity air-displacement Steam Sterilization processes at 121-135 °C.Instructions for use1. Identify the Bionova® BT20 Indicator by writing the sterilizer number (in case of having more than one), load number and processing date on the indicator label.2. Pack the biological indicator along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place this package in those areas which a priori you consider most inaccessible for the sterilizing agent (Steam). Generally, the center of the load and areas near the door are problematic.3. Sterilize as usual.4. After the sterilization process has finished, open the sterilizer door, wait for 5 minutes and remove the biological indicator from the package. CAUTION: Wear safety glasses and gloves when removing the Bionova® BT20 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.5. Allow the biological indicator to cool down to room temperature.6. Check the chemical indicator on the label of the biological indicator. A color change to brown confirms that the biological indicator has been exposed to steam. IMPORTANT: this color change does not indicate that the process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the sterilization process.7. Crush the ampoule contained in the biological indicator with an individual ampoule crusher or with the ampoule crusher placed within the top of the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature of 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 appropriate incubation conditions were met. Both the positive control indicator and the processed indicator should belong to the same batch.8. Incubate the processed biological indicator and the indicator used as a positive control for a maximum of 24 hours between 55-62 ºC. Readout should be carried out at convenient intervals of 10 hours. Color change of the growth indicator medium from purple to yellow means that a sterilization process failure has occurred.If at 24 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was effective). The positive control indicator should show a purple to yellow color change for the results to be valid. NOTE: To extend the incubation time beyond 24 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator.