MQA can provide biological indicators (BI) designed to meet the ANSI/AAMI/ISO/EN 11138 standards and USP guidelines. We purchase our BI’s from selected vendors. BI’s provided by MQA are tested for spore population and identity. D value verification can be arranged per customer request.
Biological Indicators are:
- Used to evaluate the effectiveness of sterilization processes.
- Essential in performing sterilization cycle validation.
- Used for ethylene oxide gas, dry heat, steam, and radiation sterilization processes.
- BI’s are available in a wide range of organisms, populations, and packaging.
- Steam: Geobacillus stearothermophilus ATCC® #7953
- Dry heat: Bacillus atrophaeus ATCC® #9372
- Radiation: Bacillus pumilus ATCC® #27142
- Ethylene Oxide: Bacillus atrophaeus ATCC® #9372
- BI’s are available as strips (standard size or mini), discs, suspensions, self-contained, ampoules, and custom configurations.
|Assay Description||Service Code|
|BI spore count||ML21|
|BI identity per BI lot||ML22|
|BI item inoculation per BI||ML23|
|BI sterility testing per BI||ML24|
|BI spore strips – ETO||ML25|
|BI spore strips – steam||ML26|
|BI spore strips – steam 2 organism BI||ML27|
|BI spore strips – dry heat||ML28|
|BI spore ampules – steam||ML29|
|BI spore suspension||ML30|