Crosstex’s Traditional Self-Contained Biological Indicators (SCBIs) for monitoring Ethylene Oxide (EO) sterilization consist of a durable polycarbonate vial with cap, a crushable glass ampoule with Tryptic Soy Broth (TSB) modified with pH indicator, and a disc inoculated with Bacillus atrophaeus spores.
- Reduced incubation time of 72 hours
- Visually distinct positive results indicated by the media transitioning from Green to Yellow
- Chemical Indicator on label provides instant indication of exposure
| Process | EO |
| Organism | Bacillus atrophaeus Cell Line 9372 |
| Indications for Use | The SCBIs may be utilized to monitor EO sterilization processes.This product is labeled For Industrial Use Only. |
| Incubation Time | 48 hours |
| Chemical Indicator | Each SCBI vial label contains a Chemical Indicator for instant indication of exposure. |
| SCBI Dimensions | 13 mm x 61 mm |
| Packaging | 50 SCBIs/Box |
| Compliance | ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirementsISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
USP |
| Shelf-Life | The shelf life of the SCBIs is based on the shorter of the two individual components (the media ampoule and inoculated carrier), which have independent expiration periods. |
| Storage Conditions | 15°C to 30°C, 20-70% relative humidity |