Formaldehyde Biological Indicator
Shanghai JPS Medical Co., Ltd. · #JPS-FORM-BI · source
Formaldehyde Biological Indicator
The JPS Formaldehyde Biological Indicator provides definitive lethality testing for Low-Temperature Steam and Formaldehyde (LTSF) sterilization cycles. These self-contained BIs utilize highly resistant Geobacillus stearothermophilus spores to ensure effective sterilization.
- Optimized Resistance: Uses Geobacillus stearothermophilus (ATCC 7953) validated for LTSF processes.
- Self-Contained Convenience: Combines spores and specialized media in a single, safe vial.
- Clear Interpretation: Distinct color change in the growth media indicates a sterilization failure.
- Process Indicator Label: Built-in chemical indicator on the vial label for process confirmation.
- Standard Compliance: Fully conforms to relevant ISO 11138 standards.
Reliable Efficacy Testing for LTSF Sterilization
Low-Temperature Steam and Formaldehyde (LTSF) sterilization requires stringent monitoring due to its complex parameters. The JPS Formaldehyde Biological Indicator provides the necessary assurance that these cycles have successfully achieved sterility.
The self-contained design features a glass ampoule of specialized growth media inside a plastic vial containing the spore disc. After the sterilization cycle, the ampoule is crushed, allowing the media to contact the spores. If any spores survive, they will ferment the media during incubation, causing a distinct color change (typically Purple to Yellow).
Key Advantages
- Direct Lethality Test: Proves the cycle actually killed highly resistant spores.
- Self-Contained System: Includes spores and culture media in one easy-to-use vial, minimizing handling errors.
- Clear Interpretation: A definitive color change in the media indicates a failed cycle after incubation.
- Built-in Chemical Indicator: The label on each vial features a chemical indicator to instantly show it has been processed.
- Optimized Incubation: Media formulated specifically for recovery of spores exposed to formaldehyde.
- Compliance Guarantee: Essential for load release and routine LTSF sterilizer qualification.
Product Information
| Manufacturer | Shanghai JPS Medical Co., Ltd. |
|---|---|
| Model | JPS-FORM-BI |
| Status | In Stock |
| Shelf Life | 18-24 Months (Store at room temp, away from sterilants) |
| Product Name | Formaldehyde Biological Indicator (Self-Contained) |
| Certification | CE (EU MDR), FDA Cleared, ISO 13485, ISO 11138-1 & 5 |
| Test Organism | Geobacillus stearothermophilus (ATCC 7953) |
| Packaging Unit | 50 or 100 Vials/Box |
| Incubation Time | Typically 48h (Verify specific IFU) |
| Label Indicator | Chemical indicator changes color when processed |
| Boxes Per Carton | 20 or 40 |
| Spore Population | ≥ 1.0 x 10^5 or ≥ 1.0 x 10^6 per vial |
| Result Indication | Media changes color (e.g., Purple to Yellow) if spores survive (Fail) |
| Storage Temperature | 15°C to 30°C |
| Compliance Standards | ISO 11138-1, ISO 11138-5, CE, FDA, ISO 13485 |
| Sterilization Method | Low-Temperature Steam and Formaldehyde (LTSF) |
| Storage Instructions | Store between 15°C and 30°C. Do NOT store near sterilants or chemical fumes. Protect from direct sunlight. |
| Incubation Temperature | 55°C - 60°C |
