Crosstex Inoculated Carrier Spore Discs for monitoring Ethylene Oxide (EO) and Dry Heat processes consist of:
- An inoculated carrier, 3 mm or 6 mm disc, of Bacillus atrophaeus (Cell Line 9372)
- Primary packaging in bulk
- The Spore Discs will fit into small areas of a device where a standard-sized spore strip cannot be used, such as within a syringe barrel, inside tubing and vials or under a cap
- A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)
| Process | EO / Dry Heat |
| Organism | Bacillus atrophaeus Cell Line 9372 |
| Indications for Use | The Spore Discs are designed to be placed directly into a device and utilized to monitor EO and Dry Heat sterilization process efficacy. The Spore Discs are labeled For Industrial Use Only. |
| Disc Dimensions | BG-106D: 6 mmDN18-06: 3 mm |
| Packaging | 100 Discs/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 <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs |
| Shelf Life | BG-106D: 24 months from the date of manufactureDN18-06: 30 months from the date of manufacture |
| Storage Conditions | BG-106D: 20°C to 25°C average. Excursions 15°C to 30°C allowed. 20% to 70% Relative HumidityDN18-06: 15°C to 30°C, 20-80% relative humidity |