Crosstex manufactures Spore Suspensions utilized in Gamma & E-Beam sterilization processes. The Spore Suspensions are pure suspensions of spores with known radiation resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used.
- Each vial contains 10 mL of suspension. Diluent contains 20% ethanol
- Pharmaceutical grade glass vials with screw cap and septum
- Spore Suspensions require storage under refrigerated conditions (2°C to 8°C)
- Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date
- ISO 11138-1 Compliant
| Process | Radiation (Gamma and E-Beam) |
| Organism | Bacillus pumilus Cell Line 27142 |
| Indications for Use | Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing.This product is labeled For Industrial Use Only. |
| Suspension Volume | 10 mL Diluent contains 20% Ethanol |
| Packaging | Pharmaceutical grade glass vial with screw cap and septum |
| Compliance | ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirementsUSP |
| Shelf Life | 24 months from the date of manufacture |
| Storage Conditions | Refrigerate at 2°C to 8°C |