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48h Biological Indicator for Dry Heat

Brand

Bionova

Process

Dry Heat

Packaging

50

Microorganism

Bacillus Atrophaeus (ATCC 9372)

Population

10^6

Read-Out Time

48 h

Conditions

See Product Description

Regulations

IRAM 37102-1, ISO 11138-1, ISO 11138-4

Description

Semi Self-contained Biological Indicator for Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 48 hours.

Bionova® BT30 Biological Indicator is specially designed for monitoring Dry Heat sterilization processes at 160-180 ºC .

If the sterilization process was not successful, the culture medium will change from blue to yellow after incubation at 37±2 °C, thus indicating the presence of living Bacillus atrophaeus spores. If sterilization process was successful the indicator medium will remain blue after Incubation. The final readout should be performed after 48 hours of incubation at 37±2 °C.

Directions for use

1. Identify the Bionova® BT30 tube A by writing the sterilizer number (in case of having more than one), load number, and the processing date on the indicator label.

2. Pack the biological indicator (tube A) along with the material to be sterilized in an appropriate package according to recommended practices.

WARNING! Do not sterilize the tube B that contains the ampoule. Place this package in those areas which a priori you consider more inaccessible for the sterilizing agent (dry heat). The most problematic areas are the center of the load and near the door.

3. Sterilize as usual.

4. Once the sterilization process is finished, open the door of the sterilizer chamber, let the material cool down and remove the biological indicator from package.

5. Let the biological indicator cool down until it reaches room temperature. The chemical indicator on the label will turn to brown.

6. Under sterility conditions, (laminar flow or sterile environment):

6.1. Break the ampoule inside tube B pressing on the bottom of the tube label.

6.2. Take the cap of tube B off by taking the tube by its base. Discard the cap of tube B and leave it in a vertical position.

6.3. Remove the cap of tube A by taking the tube by its base and discard the plastic tube.

6.4. Put the cap of tube A inside the plastic tube B in such a way that the spore carrier paper gets in contact with the culture medium.

CAUTION: If the product is exposed to temperatures above 180 °C or subjected to mechanical aggression, it may happen that the carrier with spores is released from the cover. In this case, when the tube is opened, the carrier should be transferred to the culture medium using a sterile clamp and in a sterile environment, under laminar flow or close to a flame.

IMPORTANT: Make sure the carrier paper of tube A does not get in contact with the exterior of tube B or any other surface.

6.5. Put the cap tightly and incubate it at 37±2 ºC. NOTE: It is recommended the use of Dual Bionova® IC10/20 or similar devices that ensure an efficient temperature control.

IMPORTANT: Use a non-sterilized biological indicator as a positive control each time a processed indicator is incubated. The positive control ensures that appropiate incubation conditions were met.

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 carried out at convenient intervals of 10 hour.

Color change of the growth indicator medium from blue to yellow means a sterilization process failure. If at 48 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was efficient). The positive control indicator should show a yellow color change for the results to be valid.

Description

Semi Self-contained Biological Indicator for Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 48 hours.

Bionova® BT30 Biological Indicator is specially designed for monitoring Dry Heat sterilization processes at 160-180 ºC .

If the sterilization process was not successful, the culture medium will change from blue to yellow after incubation at 37±2 °C, thus indicating the presence of living Bacillus atrophaeus spores. If sterilization process was successful the indicator medium will remain blue after Incubation. The final readout should be performed after 48 hours of incubation at 37±2 °C.

Directions for use

1. Identify the Bionova® BT30 tube A by writing the sterilizer number (in case of having more than one), load number, and the processing date on the indicator label.

2. Pack the biological indicator (tube A) along with the material to be sterilized in an appropriate package according to recommended practices.

WARNING! Do not sterilize the tube B that contains the ampoule. Place this package in those areas which a priori you consider more inaccessible for the sterilizing agent (dry heat). The most problematic areas are the center of the load and near the door.

3. Sterilize as usual.

4. Once the sterilization process is finished, open the door of the sterilizer chamber, let the material cool down and remove the biological indicator from package.

5. Let the biological indicator cool down until it reaches room temperature. The chemical indicator on the label will turn to brown.

6. Under sterility conditions, (laminar flow or sterile environment):

6.1. Break the ampoule inside tube B pressing on the bottom of the tube label.

6.2. Take the cap of tube B off by taking the tube by its base. Discard the cap of tube B and leave it in a vertical position.

6.3. Remove the cap of tube A by taking the tube by its base and discard the plastic tube.

6.4. Put the cap of tube A inside the plastic tube B in such a way that the spore carrier paper gets in contact with the culture medium.

CAUTION: If the product is exposed to temperatures above 180 °C or subjected to mechanical aggression, it may happen that the carrier with spores is released from the cover. In this case, when the tube is opened, the carrier should be transferred to the culture medium using a sterile clamp and in a sterile environment, under laminar flow or close to a flame.

IMPORTANT: Make sure the carrier paper of tube A does not get in contact with the exterior of tube B or any other surface.

6.5. Put the cap tightly and incubate it at 37±2 ºC. NOTE: It is recommended the use of Dual Bionova® IC10/20 or similar devices that ensure an efficient temperature control.

IMPORTANT: Use a non-sterilized biological indicator as a positive control each time a processed indicator is incubated. The positive control ensures that appropiate incubation conditions were met.

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 carried out at convenient intervals of 10 hour.

Color change of the growth indicator medium from blue to yellow means a sterilization process failure. If at 48 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was efficient). The positive control indicator should show a yellow color change for the results to be valid.

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