Self-contained spore ampoules for Steam (10^6 spores / 0,5ml)
More info about this product
Additional information
| Brand | Bionova |
|---|---|
| Process | Steam |
| Packaging | 200 (+) y 20 (-) |
| Microorganism | Geobacillus stearothermophilus (ATCC® 7953) |
| Population | 10^6 Spores/carrier |
| Read-Out Time | 48 h |
| Initial Color | Purple |
| Final Color | Yellow |
| Regulations | IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3 |
| Volume | 0.5 ml |
| Field of activity | Pharmaceutical |
Description
BT21/6 / Self-contained Spore Ampoules for Industrial Steam sterilization of liquids. Geobacillus stearothermophilus (ATCC® 7953) 10^6 spores per ampoule (7 x 40 mm). 0,5 ml of culture medium.
Bionova® BT21 Self-Contained spore ampoules have been designed for monitoring Steam sterilization processes at temperatures between 121 ºC and 135 ºC.
If the sterilization process was not effective, the indicator medium will turn to yellow after incubation between 55-62 ºC, thus indicating the presence of living Geobacillus stearothermophilus spores.
If the sterilization process was effective the indicator medium will remain the original color after incubation. The final readout should be performed after 48 hours of incubation between 55-62 ºC.
Instructions for use
1. Take the Bionova® BT21 Ampoules out of the refrigerator and leave them stabilize at room temperature up to ten minutes.
2. Place the Bionova® BT21 Ampoules inside a container with the liquid being sterilized or in a container with liquid similar to that containing the liquid to be sterilized. This container should be the same size and have the same volume as the one containing the liquid being sterilized.
3. Sterilize as usual.
4. Once the sterilization process has finished, open the sterilizer door, wait five minutes and remove the biological indicator from the container. WARNING: Wear safety glasses and gloves when removing the Bionova® BT21 Biological Indicator from the sterilized container.
5. Incubate the processed biological indicator, a negative control and a non-sterilized biological indicator as a positive control, during 48 hours between 55-62 ºC.
The positive control ensures that the incubation conditions were met.
The negative control, not being exposed to the sterilization process, can be used as a reference color to compare positive and negative results. Conversely, when used with the ampoules during the process, it ensures that any color change produced immediately after sterilization is the result of the process and not due to germination and/or spore growth.
Readout should be performed at convenient intervals of 12 hours.
It is recommended the use of Bionova® IC10/20 Dual Incubator or similar devices that assure an efficient temperature control. WARNING: Traditional culture stoves have thermal profiles that differ from the above recommended incubators, thus their use might affect or delay the Bionova® BT21 Biological Indicators result.
A color change to yellow of the proccesed biological 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, meaning the sterilization process was effective. The positive control indicator should turn to yellow for the result to be valid and the negative control should remain the same color.
Description
BT21/6 / Self-contained Spore Ampoules for Industrial Steam sterilization of liquids. Geobacillus stearothermophilus (ATCC® 7953) 10^6 spores per ampoule (7 x 40 mm). 0,5 ml of culture medium.
Bionova® BT21 Self-Contained spore ampoules have been designed for monitoring Steam sterilization processes at temperatures between 121 ºC and 135 ºC.
If the sterilization process was not effective, the indicator medium will turn to yellow after incubation between 55-62 ºC, thus indicating the presence of living Geobacillus stearothermophilus spores.
If the sterilization process was effective the indicator medium will remain the original color after incubation. The final readout should be performed after 48 hours of incubation between 55-62 ºC.
Instructions for use
1. Take the Bionova® BT21 Ampoules out of the refrigerator and leave them stabilize at room temperature up to ten minutes.
2. Place the Bionova® BT21 Ampoules inside a container with the liquid being sterilized or in a container with liquid similar to that containing the liquid to be sterilized. This container should be the same size and have the same volume as the one containing the liquid being sterilized.
3. Sterilize as usual.
4. Once the sterilization process has finished, open the sterilizer door, wait five minutes and remove the biological indicator from the container. WARNING: Wear safety glasses and gloves when removing the Bionova® BT21 Biological Indicator from the sterilized container.
5. Incubate the processed biological indicator, a negative control and a non-sterilized biological indicator as a positive control, during 48 hours between 55-62 ºC.
The positive control ensures that the incubation conditions were met.
The negative control, not being exposed to the sterilization process, can be used as a reference color to compare positive and negative results. Conversely, when used with the ampoules during the process, it ensures that any color change produced immediately after sterilization is the result of the process and not due to germination and/or spore growth.
Readout should be performed at convenient intervals of 12 hours.
It is recommended the use of Bionova® IC10/20 Dual Incubator or similar devices that assure an efficient temperature control. WARNING: Traditional culture stoves have thermal profiles that differ from the above recommended incubators, thus their use might affect or delay the Bionova® BT21 Biological Indicators result.
A color change to yellow of the proccesed biological 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, meaning the sterilization process was effective. The positive control indicator should turn to yellow for the result to be valid and the negative control should remain the same color.