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48h Biological Indicator for room disinfection with aerosolized H2O2

Brand

Bionova

Process

Hydrogen Peroxide

Packaging

100

Microorganism

Geobacillus Stearothermophilus (ATCC 7953)

Population

10^4 Spores/carrier

Read-Out Time

48 h

Conditions

See Product Description

Regulations

ISO 13485

Description

Monitoring of airborne and surface disinfection processes by Hydrogen Peroxide (H2O2).

Bionova® BT94 BioSurf Biological Indicator has been designed for monitoring of airborne and surface disinfection processes by Hydrogen Peroxide.

The system consists of two tubes: tube A which contains the spores to

challenge the disinfection process and tube B which is used to reveal its success.

If the disinfection process was not effective, the indicator medium will turn from purple to yellow after 48-hour incubation between 55-62 °C, thus indicating the presence of living Geobacillus stearothermophilus spores. If the disinfection process was effective, the indicator medium will remain purple after incubation for 48 hours between 55-62 °C.

Instructions for use

1. Inside the room to be disinfected open tube A and place the lid down and the carrier up, using the holder specially designed for the product. The rest of the tube can be discarded. Thus, Geobacillus stearothermophilus spores are exposed to evaluate the disinfection process. Place tube B without uncovering in the remaining position of the holder.

WARNING! Place the holder with the indicator in those areas that you consider a priori more inaccessible to the Hydrogen Peroxide. Places subject to minimal flows are suggested such as corners of the room, sectors in and around the equipment and spaces between disposable materials that will be used in the room. To define the most difficult areas to decontaminate, it is recommended to use several indicators in the same process.

NOTE: A scheme of the room is attached to the product, where you can mark the position of the indicators with respect to the disinfection device.

2. Carry out the process of decontamination and aeration as usual.

3. Start the Bionova® IC10/20 incubator and select the temperature (60 °C).

IMPORTANT: Always wear both sterile clothing and personal protective equipment (glasses, mask, gloves) to enter the enclosed area. Avoid sudden movements of air. Do not reveal Bionova® BT94 BioSurf Biological Indicator until the incubator reaches the required temperature.

4. Verify that the chemical indicator printed on the label of tube B turned to green. A color change confirm that the indicator has been exposed to Hydrogen Peroxide.

IMPORTANT: This color change is not evidence that the process was successful. If the chemical indicator color has not changed, review the process.

5. Crush the ampoule contained in the biological indicator with an individual ampoule crusher or with the ampoule crusher placed within 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 completely embeds the filter located at the bottom of the tube.

6. Remove the lid of tube B by taking the tube through the base. Discard it keeping the tube in vertical position.

7. Place the exposed lid of tube A on tube B so that the carrier contacts the culture medium.

8. Press the lid until the plastic tube is completely closed.

IMPORTANT: Use a non-processed biological indicator as a positive control every time a processed indicator is incubated. The positive control ensures that the incubation conditions were adequate.

9. Incubate the processed biological indicator along with the indicator used as a positive control for a maximum of 48 hours between 55-62 °C.

Color change of the growth indicator medium from purple to yellow means that disinfection process was not effective. If after incubation there is no color change in the processed indicators, a final negative result is obtained (the disinfection 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 48 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator.

Description

Monitoring of airborne and surface disinfection processes by Hydrogen Peroxide (H2O2).

Bionova® BT94 BioSurf Biological Indicator has been designed for monitoring of airborne and surface disinfection processes by Hydrogen Peroxide.

The system consists of two tubes: tube A which contains the spores to

challenge the disinfection process and tube B which is used to reveal its success.

If the disinfection process was not effective, the indicator medium will turn from purple to yellow after 48-hour incubation between 55-62 °C, thus indicating the presence of living Geobacillus stearothermophilus spores. If the disinfection process was effective, the indicator medium will remain purple after incubation for 48 hours between 55-62 °C.

Instructions for use

1. Inside the room to be disinfected open tube A and place the lid down and the carrier up, using the holder specially designed for the product. The rest of the tube can be discarded. Thus, Geobacillus stearothermophilus spores are exposed to evaluate the disinfection process. Place tube B without uncovering in the remaining position of the holder.

WARNING! Place the holder with the indicator in those areas that you consider a priori more inaccessible to the Hydrogen Peroxide. Places subject to minimal flows are suggested such as corners of the room, sectors in and around the equipment and spaces between disposable materials that will be used in the room. To define the most difficult areas to decontaminate, it is recommended to use several indicators in the same process.

NOTE: A scheme of the room is attached to the product, where you can mark the position of the indicators with respect to the disinfection device.

2. Carry out the process of decontamination and aeration as usual.

3. Start the Bionova® IC10/20 incubator and select the temperature (60 °C).

IMPORTANT: Always wear both sterile clothing and personal protective equipment (glasses, mask, gloves) to enter the enclosed area. Avoid sudden movements of air. Do not reveal Bionova® BT94 BioSurf Biological Indicator until the incubator reaches the required temperature.

4. Verify that the chemical indicator printed on the label of tube B turned to green. A color change confirm that the indicator has been exposed to Hydrogen Peroxide.

IMPORTANT: This color change is not evidence that the process was successful. If the chemical indicator color has not changed, review the process.

5. Crush the ampoule contained in the biological indicator with an individual ampoule crusher or with the ampoule crusher placed within 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 completely embeds the filter located at the bottom of the tube.

6. Remove the lid of tube B by taking the tube through the base. Discard it keeping the tube in vertical position.

7. Place the exposed lid of tube A on tube B so that the carrier contacts the culture medium.

8. Press the lid until the plastic tube is completely closed.

IMPORTANT: Use a non-processed biological indicator as a positive control every time a processed indicator is incubated. The positive control ensures that the incubation conditions were adequate.

9. Incubate the processed biological indicator along with the indicator used as a positive control for a maximum of 48 hours between 55-62 °C.

Color change of the growth indicator medium from purple to yellow means that disinfection process was not effective. If after incubation there is no color change in the processed indicators, a final negative result is obtained (the disinfection 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 48 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator.

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