Steam Biological indicator is specially designed for monitoring steam sterilization processes. If the sterilization process is unsuccessful, after incubation at 60±2°C, the color of the medium will change from purple to yellow or its shades, indicating the presence of viable Geobacillus stearothermophilus (ATCC 7953) spores. If successful, there will be no change in color. The final readout should be taken after 24 hours.
⚠️ Important Notices:
- Do not use for ETO, dry heat, formaldehyde, hydrogen peroxide or other sterilization processes.
- Do not reuse the biological indicators.
- Complies with ISO 11138-1:2017 and ISO 11138-3:2017.
| Product Name | Self-contained Biological Indicator for Moist Heat Sterilization |
| Type | BF-BI4 / BF-B16 |
| Units per Pack | 25 pcs/box |
| Indicator Bacteria | G. stearothermophilus, ATCC7953 |
| Spore Population | ≥1.0×10⁵ cfu |
| D-Value | ≥1.5min (at 121ºC saturated steam) |
| Incubation Time | 24h - 48h |
| Result Interpretation | Color Change: Positive (Failed); No Color Change: Negative (Success) |
| Certificates | ISO13485 |
Components: Consists of medium in a glass ampoule, a disc inoculated with Geobacillus stearothermophilus spores, a chemical indicator strip, a plastic tube, a plastic cap, and a filter paper inside the cap.
We operate professional manufacturing facilities specializing in disposable dental and medical products. Our supply range includes: sterilization pouches & rolls, dental bibs, saliva ejectors, face masks, surgical gowns, dental kits, alcohol pads, and various surgical instruments. All products are manufactured under strict quality control standards.
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Frequently Asked Questions
How do I interpret the sterilization results?
If the medium remains purple after incubation, the sterilization was successful (Negative). If it changes to yellow, it indicates viable spores are present and the process failed (Positive).
What is the required incubation temperature?
The indicators should be incubated at a temperature of 60±2°C.
How long is the incubation period?
The final readout is typically taken after 24 hours, though some protocols may extend to 48 hours for complete verification.
Can these indicators be used for EO gas sterilization?
No, these specific indicators are designed only for moist heat (steam) sterilization processes.
What is the shelf life and storage of the product?
The product has a quality guarantee period of two years. It should be stored according to standard medical consumable requirements.
What standards do these indicators meet?
They are in full compliance with ISO 11138-1:2017 and ISO 11138-3:2017 standards.
Estetik Medical
