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24h Biological Indicator for Hydrogen Peroxide

Brand

Bionova

Process

Hydrogen Peroxide

Packaging

100

Microorganism

Geobacillus Stearothermophilus (ATCC 7953)

Population

10^5, 10^6

Read-Out Time

24 h

Conditions

See Product Description

Regulations

IRAM 37102-1, ISO 11138-1

Description

BT91 / Self-contained Biological Indicator for Plasma or Vaporized Hydrogen Peroxide sterilization processes. Geobacillus stearothermophilus (ATCC7953) 10^5 or 10^6 spores per vial. Readout: 24 hours.

Bionova® BT91 Biological Indicator is specifically designed for the monitoring of Plasma or Vaporized Hydrogen Peroxide sterilization processes. If sterilization process was not successful, the indicator media will change from purple to yellow after incubation between 55-62 ºC, thus indicating the presence of live Geobacillus stearotermophilus spores.

If the sterilization process was effective, the indicator media will remain purple after incubation. The final readout should be made after 24 hours of incubation between 55-62 ºC.

Instructions for use

1. Identify the Bionova® BT91 Indicator 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 appropriated package according to recommended sterilization practices. Place this package in those areas which a priori you consider most inaccessible for sterilizing agent.

3. Sterilize as usual.

4. After the sterilization process has finished, remove the biological indicator from sterilization package for incubation.

5. Check the chemical indicator on the label of biological indicator. A color change to green confirms that the biological indicator has been exposed to Hydrogen Peroxide. IMPORTANT:

This color change does not indicatethat the process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the sterilization process.

6. Crush the glass ampule contained in the biological indicator and incubate between 55-62 ºC.

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. 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 a positive control for a maximum of 24 hours between 55-62 ºC.

A color change from purple to yellow of the growth indicator medium means that sterilization process failure has occurred. If after 24 hours there is no color change in the processed indicators, a final negative result is made (the sterilization process was effective). The positive control indicator should show a purple to yellow color change for the result to be valid.

NOTE: To extend the incubation time to more than 24 hours, we recommend using a humidified environment to prevent the complete evaporation of the culture medium contained in the indicator

Description

BT91 / Self-contained Biological Indicator for Plasma or Vaporized Hydrogen Peroxide sterilization processes. Geobacillus stearothermophilus (ATCC7953) 10^5 or 10^6 spores per vial. Readout: 24 hours.

Bionova® BT91 Biological Indicator is specifically designed for the monitoring of Plasma or Vaporized Hydrogen Peroxide sterilization processes. If sterilization process was not successful, the indicator media will change from purple to yellow after incubation between 55-62 ºC, thus indicating the presence of live Geobacillus stearotermophilus spores.

If the sterilization process was effective, the indicator media will remain purple after incubation. The final readout should be made after 24 hours of incubation between 55-62 ºC.

Instructions for use

1. Identify the Bionova® BT91 Indicator 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 appropriated package according to recommended sterilization practices. Place this package in those areas which a priori you consider most inaccessible for sterilizing agent.

3. Sterilize as usual.

4. After the sterilization process has finished, remove the biological indicator from sterilization package for incubation.

5. Check the chemical indicator on the label of biological indicator. A color change to green confirms that the biological indicator has been exposed to Hydrogen Peroxide. IMPORTANT:

This color change does not indicatethat the process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the sterilization process.

6. Crush the glass ampule contained in the biological indicator and incubate between 55-62 ºC.

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. 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 a positive control for a maximum of 24 hours between 55-62 ºC.

A color change from purple to yellow of the growth indicator medium means that sterilization process failure has occurred. If after 24 hours there is no color change in the processed indicators, a final negative result is made (the sterilization process was effective). The positive control indicator should show a purple to yellow color change for the result to be valid.

NOTE: To extend the incubation time to more than 24 hours, we recommend using a humidified environment to prevent the complete evaporation of the culture medium contained in the indicator

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