Sterifast Self-Contained Biological Indicator Steam
Self-contained Biological Indicators (SCBI) designed for monitoring the efficacy of Steam sterilization processes, with a 24-hour incubation readout, in healthcare and industrial applications. Each unit consists of a thermoplastic vial and cap, a crushable media ampoule containing modified Trypticase Soy Broth (TSB) with a pH indicator, and an inoculated carrier (disc) of Geobacillus stearothermophilus (ATCC 7953). The modified TSB transitions from purple to yellow and/or develops turbidity in the presence of bacterial growth, providing a clear visual result. The vial label also incorporates a built-in Chemical Indicator (CI) strip that changes from yellow to brown/black when exposed to a steam process, offering an immediate (though non-conclusive) process indication alongside the biological result.
Key Features
- Self-contained design combining biological indicator and growth media in a single vial — no separate ampoule handling required
- Inoculated with Geobacillus stearothermophilus (ATCC 7953), the reference organism for steam sterilization monitoring
- Integrated Chemical Indicator (CI) strip on the vial label for immediate visual process confirmation
- Clear pass/fail readout: purple (no growth) vs. yellow/turbid (growth detected) after 24h incubation
- Available in two population levels (10⁵ and 10⁶) to suit different validation requirements
- Compliant with ISO 11138-1, ISO 11138-3 and USP <55> standards
- Autoclavable for safe disposal after use
Technical Data
| Specification | Ref. 330606024 | Ref. 330606023 |
| Process | Steam | Steam |
| Population | 1.0 to 5.0 x 10⁵ per disc | 1.0 to 5.0 x 10⁶ per disc |
| Organism | Geobacillus stearothermophilus (ATCC 7953) | Geobacillus stearothermophilus (ATCC 7953) |
| Incubation | 55°C to 60°C, minimum 24 hours | 55°C to 60°C, minimum 24 hours |
| D value at 121°C ± 0.5°C | 1.5 to 3.0 minutes | 1.5 to 3.0 minutes |
| z value | ≥6°C | ≥6°C |
| Dimensions | 10 mm x 45.5 mm | 10 mm x 45.5 mm |
| Packaging | 100/Box | 100/Box |
| Chemical Indicator | Integrated CI strip, yellow → brown/black on steam exposure | Integrated CI strip, yellow → brown/black on steam exposure |
| Storage temperature | 20°C to 25°C average (excursions 15°C to 30°C allowed) | 20°C to 25°C average (excursions 15°C to 30°C allowed) |
| Storage humidity | 20% to 70% RH | 20% to 70% RH |
| Purity | No evidence of contamination affecting the finished product | No evidence of contamination affecting the finished product |
Applications
- Routine monitoring of every steam sterilization load in dental and medical/hospital settings
- Validation and requalification of steam sterilizers (autoclaves)
- Monitoring of hard-to-sterilize or difficult-access loads, per sterilization validation protocols
- Central Sterile Supply Department (CSSD) quality control programs