Self-contained design combining biological indicator and growth media in a single vial — no separate ampoule handling required
Made by us
Sterilization › Sterilizers
WEB-ST-023
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.
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 |
Documentation
Downloads.
Product enquiry
Plan your next step.
Explore this product with our team.