Biological Indicator Test Strip
Beya Medical Biological Indicator Test Strips are small strips of special filter paper inoculated with bacterial spores, either Bacillus atrophaeus (BA) for ethylene oxide and dry heat sterilization or Geobacillus stearothermophilus (GS) for saturated steam sterilization. Each strip is packaged in a glassine envelope and is used to validate or requalify sterilization processes.. Bacillus atrophaeus (ATCC 9372) 10^6 spores per strip.
Instructions for use
- Identify Beya Medical Biological Indicator Test Strips envelope by writing on its back the sterilizer number (in case of having more than one), load number and processing date.
- Pack it in appropriate package along with material to be sterilized, according to recommended sterilization practices. Place the envelope in those areas you a priori consider more inaccessible for sterilizing agent. A typical problematic area is the load center.
- Sterilize as usual.
- After the sterilization process has finished, you can:
- Remove the Beya Medical Biological Indicator Test Strips envelope from the package for processing and incubation.
- For Ethylene Oxide sterilization, you can aerate the package containing the biological indicator with the rest of the load or remove the biological indicator from the sterilization package for incubation in MC-BT10 culture medium or any other appropriate growth medium prior to material aeration.
- Tear up the envelope at one end very carefully under sterility conditions (eg. laminar flow cabinet) and transfer spore strip with a sterile clamp MC-BT10 Growth Medium tube, or to any other appropriate growth medium.
IMPORTANT! Use latex gloves and chin strap when transferring spore strips from the envelope to growth medium tube. WARNING! Avoid spore strip contact with any kind of surface including the outer part of growth medium tube and of Beya Medical Biological Indicator Test Strips envelope.
IMPORTANT: Use a non-sterilized spore strip as a positive control at least once per day, when a sterilization cycle is run. 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.
- 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 MC-BT10 Growth medium to yellow means a failure on sterilization process.
If after 48 hours no colour change is visible on MC-BT10 Growth Medium, the result is negative (i.e. the sterilization process was successful).
MC-BT10 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.
Additional Information
PACKAGING : 100 PER BOX
REGULATION : ISO 13485, ISO 11138-1, ISO 11138-2 ,ISO 11138 – 4
POPULATION : 10^6 SPORES PER CARRIER
READOUT : 48 HOURS
INCUBATION TEMP : 37 ± 2 ºC
