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48h Biological Indicator for EtO

Brand

Bionova

Process

Ethylene Oxide

Packaging

30, 100

Microorganism

Bacillus Atrophaeus (ATCC 9372)

Population

10^6

Read-Out Time

48 h

Conditions

See Product Description

Regulations

IRAM 37102-1, IRAM 37102-2, ISO 11138-1, ISO 11138-2

Description

BT10 / Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 48 hours.

Monitoring Ethylene Oxide Sterilization Processes.

Instructions for use

1.Identify the Bionova® BT10 Indicator tube by writing the sterilizer number (in case of having more than one sterilizer), 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 (EO). Generalla problematic area is the center of the load or near the door.

3.Sterilize as usual.

4.After the sterilization process has finished, you can:

A.Remove the biological indicator from the sterilization package for incubation prior to material aeration.

B.Aerate the package containing the biological indicator with the rest of the load and then remove the biological indicator for incubation.

CAUTION: Wear safety glasses and gloves when removing the Bionova® BT10 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.Check the chemical indicator on the label of the biological indicator. A color change to green confirms that the biological indicator has been exposed to Ethylene Oxide. 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.

6.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 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; 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 biological indicator and the indicator used as positive control for a maximum of 48 hours at 37 ± 2 ºC. Readout should be performed at convenient intervals of 10 hours. A color change from blue to yellow of the growth indicator medium means a sterilization process failure has occurred.

If after 48 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was satisfactory). The positive control indicator should show a yellow color change for the results to be valid.

NOTE: To extend the incubation time beyond 48 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator. Record the positive results and discard the biological indicators immediately as described below.

Description

BT10 / Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 48 hours.

Monitoring Ethylene Oxide Sterilization Processes.

Instructions for use

1.Identify the Bionova® BT10 Indicator tube by writing the sterilizer number (in case of having more than one sterilizer), 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 (EO). Generalla problematic area is the center of the load or near the door.

3.Sterilize as usual.

4.After the sterilization process has finished, you can:

A.Remove the biological indicator from the sterilization package for incubation prior to material aeration.

B.Aerate the package containing the biological indicator with the rest of the load and then remove the biological indicator for incubation.

CAUTION: Wear safety glasses and gloves when removing the Bionova® BT10 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.Check the chemical indicator on the label of the biological indicator. A color change to green confirms that the biological indicator has been exposed to Ethylene Oxide. 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.

6.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 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; 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 biological indicator and the indicator used as positive control for a maximum of 48 hours at 37 ± 2 ºC. Readout should be performed at convenient intervals of 10 hours. A color change from blue to yellow of the growth indicator medium means a sterilization process failure has occurred.

If after 48 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was satisfactory). The positive control indicator should show a yellow color change for the results to be valid.

NOTE: To extend the incubation time beyond 48 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator. Record the positive results and discard the biological indicators immediately as described below.

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