Sterifast Self-Contained Biological Indicator VH2O2
Self-Contained Biological Indicator (SCBI) designed to monitor the efficacy of VH2O2 (vaporized hydrogen peroxide) plasma sterilization processes. The device integrates a spore carrier and a crushable growth media ampule within a single thermoplastic vial, enabling activation and incubation without transferring components between containers. The carrier is inoculated with Geobacillus stearothermophilus (ATCC 7953), the reference organism for VH2O2 process validation, at a population level of 10⁶. A color-based readout system indicates sterilization outcome: growth is signaled by a color shift from purple to yellow and/or turbidity in the media, providing a clear pass/fail interpretation after incubation.
Key Features
- Self-contained design: thermoplastic vial, crushable media ampule, and inoculated carrier in one unit
- Inoculated with Geobacillus stearothermophilus (ATCC 7953), population 1.0–5.0 × 10⁶ per disc
- Modified Trypticase Soy Broth (TSB) media with integrated pH indicator (purple → yellow on growth)
- Integrated chemical indicator (CI) strip on the vial label for immediate process exposure verification (purple → pink)
- Rapid resistance profile: D-value < 1 minute at 50°C, 2.5 mg/L using 59% H2O2
- Minimum incubation time of 24 hours at 55–60°C
- Suitable for routine load monitoring in industrial and clinical VH2O2 sterilization settings
Technical Data
| Specification | Value |
| Process monitored | VH2O2 (vaporized hydrogen peroxide) |
| Reference organism | Geobacillus stearothermophilus (ATCC 7953) |
| Population | 1.0 to 5.0 × 10⁶ per disc |
| Post-market population criteria | 50% to 300% of certified population |
| VH2O2 resistance (D-value) | < 1 minute at 50°C, 2.5 mg/L using 59% H2O2 |
| Incubation temperature | 55°C to 60°C |
| Incubation time | Minimum 24 hours |
| Dimensions | 10 mm x 45.5 mm |
| Packaging | 100 units/box |
| Chemical Indicator | Integrated CI strip; purple → pink on VH2O2 exposure |
| Storage temperature | 20°C to 25°C (excursions 15°C to 30°C permitted) |
| Storage relative humidity | 20% to 70% |
| Storage conditions | Keep dry, away from sunlight, heat, radioactive sources and sterilizing agents; do not freeze or refrigerate |
| Purity | No contamination present in sufficient numbers to adversely affect the finished product |
Applications
- Routine monitoring of VH2O2/plasma sterilization cycle efficacy in CSSD and industrial settings
- Placement inside representative materials or directly within the sterilization chamber, positioned according to validated sterilization protocols or SOPs, in the most challenging-to-sterilize locations
- Recommended for inclusion in every load for maximum process control
- Positive control indicator use alongside processed units to validate test result reliability