Sterifast Self-Contained Biological Indicator Steam
SterifastSelf-contained Biological Indicators (SCBI) designed for monitoring the efficacy of Steam sterilization processes, with a 24-hour incubation readout, in healthcare and industrial applications.
- Dimensions
- Ref. 330606024: 10 mm x 45.5 mm; Ref. 330606023: 10 mm x 45.5 mm
- Process
- Ref. 330606024: Steam; Ref. 330606023: Steam
- Population
- Ref. 330606024: 1.0 to 5.0 x 10⁵ per disc; Ref. 330606023: 1.0 to 5.0 x 10⁶ per disc
- Organism
- Ref. 330606024: Geobacillus stearothermophilus (ATCC 7953); Ref. 330606023: Geobacillus stearothermophilus (ATCC 7953)
Overview
What it does
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
What makes it different
- 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
Applications
Where it's used
- 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
Technical specifications
The numbers
| Specification | Value |
|---|---|
| Process | Ref. 330606024: Steam; Ref. 330606023: Steam |
| Population | Ref. 330606024: 1.0 to 5.0 x 10⁵ per disc; Ref. 330606023: 1.0 to 5.0 x 10⁶ per disc |
| Organism | Ref. 330606024: Geobacillus stearothermophilus (ATCC 7953); Ref. 330606023: Geobacillus stearothermophilus (ATCC 7953) |
| Incubation | Ref. 330606024: 55°C to 60°C, minimum 24 hours; Ref. 330606023: 55°C to 60°C, minimum 24 hours |
| D value at 121°C ± 0.5°C | Ref. 330606024: 1.5 to 3.0 minutes; Ref. 330606023: 1.5 to 3.0 minutes |
| z value | Ref. 330606024: ≥6°C; Ref. 330606023: ≥6°C |
| Dimensions | Ref. 330606024: 10 mm x 45.5 mm; Ref. 330606023: 10 mm x 45.5 mm |
| Packaging | Ref. 330606024: 100/Box; Ref. 330606023: 100/Box |
| Chemical Indicator | Ref. 330606024: Integrated CI strip, yellow → brown/black on steam exposure; Ref. 330606023: Integrated CI strip, yellow → brown/black on steam exposure |
| Storage temperature | Ref. 330606024: 20°C to 25°C average (excursions 15°C to 30°C allowed); Ref. 330606023: 20°C to 25°C average (excursions 15°C to 30°C allowed) |
| Storage humidity | Ref. 330606024: 20% to 70% RH; Ref. 330606023: 20% to 70% RH |
| Purity | Ref. 330606024: No evidence of contamination affecting the finished product; Ref. 330606023: No evidence of contamination affecting the finished product |
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