Self-contained format: no separate culture media handling required
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Sterilization › Sterilizers
WEB-ST-024
Sterifast Self-Contained Biological Indicator EO
SterifastSelf-Contained Biological Indicators (SCBI) for monitoring Ethylene Oxide (EO) sterilization processes, with a 24-hour incubation readout.
- Dimensions
- 10 mm x 45.5 mm
- Sterilization Process
- Ethylene Oxide (EO)
- Microorganism
- Bacillus subtilis var. nigra (ATCC 9372)
- Population
- 1.0 to 5.0 × 10⁵ per disc
Overview
What it does.
Self-Contained Biological Indicators (SCBI) for monitoring Ethylene Oxide (EO) sterilization processes, with a 24-hour incubation readout. Each unit consists of a thermoplastic vial and cap, a crushable media ampule containing modified Trypticase Soy Broth (TSB) with a pH indicator, and an inoculated carrier disc of Bacillus subtilis var. nigra (ATCC 9372) at a population level of 10⁵. The modified TSB medium transitions from its initial blue-green color to yellow and/or develops turbidity in the presence of bacterial growth, providing a reliable biological confirmation of EO sterilization efficacy.
Key features
What makes it different.
Population level of 10⁵ Bacillus subtilis var. nigra (ATCC 9372) spores per disc
Integrated chemical indicator (CI) strip on the vial label, transitioning from purple to pink upon EO exposure
Color-change readout: blue-green (negative) to yellow and/or turbidity (positive)
24-hour incubation at 37°C for result readout
Designed for use in the most challenging-to-sterilize position within the load
Not for refrigeration; contains live cultures requiring careful handling
Applications
Where it's used.
- Routine biological monitoring of EO sterilization cycles in industrial and healthcare settings
- Process validation and efficacy verification for EO sterilizers
- Recommended for inclusion with every sterilization load to ensure maximum control of sterilized goods
Technical specifications
The numbers.
| Specification | Value |
|---|---|
| Sterilization Process | Ethylene Oxide (EO) |
| Microorganism | Bacillus subtilis var. nigra (ATCC 9372) |
| Population | 1.0 to 5.0 × 10⁵ per disc |
| Incubation Temperature | 37°C |
| Incubation Time | Minimum 24 hours |
| Dimensions | 10 mm x 45.5 mm |
| Packaging | 100 units/box |
| Chemical Indicator | Integrated CI strip; purple to pink color change upon EO exposure |
| EO Resistance (D-value) | < 1 minute at 50°C, 2.5 mg/L EO |
| Post-Market Criteria | Population: 50% to 300% of certified population |
| Storage Temperature | 20°C to 25°C average (excursions 15°C to 30°C permitted) |
| Storage Humidity | 20% to 70% relative humidity |
| Storage Conditions | Do not freeze; do not refrigerate; keep away from sunlight; keep dry |
| Disposal | Autoclave for ≥30 minutes at 121°C, or per other validated disposal cycle |
Documentation
Downloads.
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