Spore strips for Gamma Radiation (10^6 spores)
More info about this product
Additional information
| Brand | Bionova |
|---|---|
| Process | Gamma Irradiation |
| Packaging | 100 |
| Microorganism | Bacillus pumilus (ATCC® 27142) |
| Population | 10^6 Spores/carrier |
| Read-Out Time | 48 h |
| Regulations | IRAM 37102-1, ISO 11138-1 |
| Field of activity | Pharmaceutical |
Description
BT70/6 / Spore Strips Biological Indicator for Gamma Radiation sterilization processes. Bacillus pumilus (ATCC® 27142) 10^6 spores per strip.
The envelope containing Bionova® BT70 Spore Strip is specifically designed to control Gamma Radiation sterilization processes. Spore strips should be incubated in Bionova® MC1020-2 Growth Medium tube or in appropriate growth medium for Bacillus pumilus growth.
If the sterilization process was not successful, MC1020-2 Growth Medium will turn to yellow after incubation at 37±2 ºC, thus indicating the existence of living Bacillus pumilus spores on the strips. If the sterilization process was successful, MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 48 hours of growth medium incubation at 37±2 ºC.
Directions for use
1. Identify Bionova® BT70 envelope by writing on its back the sterilizer number (in case of having more than one), load number and processing date.
2. Pack it in appropriate package along with material to be sterilized, according to recommended sterilization practices. Place the envelope in those areas you consider a priori more inaccessible for the sterilizing agent. A typical problematic area is the load center.
3. Sterilize as usual.
4. After sterilization process has finished remove Bionova® BT70 envelope from the sterilization package used for processing and incubation.
5. Tear up the envelope at one end very carefully under sterility conditions (eg. laminar flow cabinet) and transfer the spore strip with a sterile clamp to MC1020-2 Growth Medium tube, or to any other appropiate growth medium.
IMPORTANT: Use latex gloves and chin strap when transferring spore strips from the envelope to MC1020-2 Growth Medium tube. WARNING: Avoid spore strip contact with any kind of surface including the outer part of growth medium tube and of Bionova® BT70 envelope.
IMPORTANT: Use a spore strip which has not been subjected to the sterilization process as a positive control each time a processed strip is incubated. Both, processed spore strip and the strip used as positive control must belong to the same batch. Positive control guarantees that the incubation was carried out under appropriate conditions.
6. Incubate processed spore strips along with the strip used as positive control during a maximum of 48 hours at 37±2 ºC. It is advisable to make observations every 10 hours. Color change of MC1020-2 Growth Medium to yellow means failure of the sterilization process.
If after incubation, no color change is visible on MC1020-2 Growth Medium, the result is negative (i.e. the sterilization process was successful). MC1020-2 Indicating Medium used for incubating the spores strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.
Description
BT70/6 / Spore Strips Biological Indicator for Gamma Radiation sterilization processes. Bacillus pumilus (ATCC® 27142) 10^6 spores per strip.
The envelope containing Bionova® BT70 Spore Strip is specifically designed to control Gamma Radiation sterilization processes. Spore strips should be incubated in Bionova® MC1020-2 Growth Medium tube or in appropriate growth medium for Bacillus pumilus growth.
If the sterilization process was not successful, MC1020-2 Growth Medium will turn to yellow after incubation at 37±2 ºC, thus indicating the existence of living Bacillus pumilus spores on the strips. If the sterilization process was successful, MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 48 hours of growth medium incubation at 37±2 ºC.
Directions for use
1. Identify Bionova® BT70 envelope by writing on its back the sterilizer number (in case of having more than one), load number and processing date.
2. Pack it in appropriate package along with material to be sterilized, according to recommended sterilization practices. Place the envelope in those areas you consider a priori more inaccessible for the sterilizing agent. A typical problematic area is the load center.
3. Sterilize as usual.
4. After sterilization process has finished remove Bionova® BT70 envelope from the sterilization package used for processing and incubation.
5. Tear up the envelope at one end very carefully under sterility conditions (eg. laminar flow cabinet) and transfer the spore strip with a sterile clamp to MC1020-2 Growth Medium tube, or to any other appropiate growth medium.
IMPORTANT: Use latex gloves and chin strap when transferring spore strips from the envelope to MC1020-2 Growth Medium tube. WARNING: Avoid spore strip contact with any kind of surface including the outer part of growth medium tube and of Bionova® BT70 envelope.
IMPORTANT: Use a spore strip which has not been subjected to the sterilization process as a positive control each time a processed strip is incubated. Both, processed spore strip and the strip used as positive control must belong to the same batch. Positive control guarantees that the incubation was carried out under appropriate conditions.
6. Incubate processed spore strips along with the strip used as positive control during a maximum of 48 hours at 37±2 ºC. It is advisable to make observations every 10 hours. Color change of MC1020-2 Growth Medium to yellow means failure of the sterilization process.
If after incubation, no color change is visible on MC1020-2 Growth Medium, the result is negative (i.e. the sterilization process was successful). MC1020-2 Indicating Medium used for incubating the spores strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.
