Biological Indicators for Steam Sterilization – Infection Control

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Product Description

Basic Specifications
Model NO.
BF-B16
Sterilization
Moist Heat Sterilization
Quality Guarantee
Two Years
Bacteria Type
G. Stearothermophilus
Sterile Method
Eo or Steam
Capacity
250,000 PCS/Day
Transport Package
25 PCS/Box
Specification
ATCC7953
Product Description

The 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 still viable Geobacillus stearothermophilus (ATCC 7953) spores.

If the sterilization process is successful, there will be no change in the color of the medium after incubation, it will remain in its original color. The last readout should be taken after 24 hours of incubation at 60±2°C.

Important Usage Guidelines
  • Do not use for ETO, dry heat, formaldehyde, hydrogen peroxide or other sterilization processes.
  • Single-use only. Do not reuse the biological indicators.
  • In compliance with ISO 11138-1:2017 and ISO 11138-3:2017.
Product Name: Self-contained Biological Indicator for Moist Heat Sterilization
Type: BF-BI4
Units per Pack: 25 pcs/box
Indicator Bacteria: G. stearothermophilus, ATCC7953
Spore population: ≥1.0×10⁵ cfu
D-Value: ≥1.5min (Condition: saturated steam 121ºC)
Incubation Time: 48h
Result Interpretation: Color Change: positive; No Color Change: negative
Certificates: ISO13485
Product Composition

Consists of medium in a glass ampoule, a disc inoculated with Geobacillus stearothermophilus (ATCC 7953) spores, a chemical indicator strip, a plastic tube, a plastic cap, and a filter paper inside the cap.

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Packaging & Shipping
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Established in 2015, we operate a 100,000 square meter factory, standing as one of the most professional disposable medical and dental product suppliers. Our range includes sterilization pouches, dental bibs, saliva ejectors, face masks, surgical gowns, barrier films, and various dental instruments.

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Frequently Asked Questions
What is the required incubation temperature for the Steam Biological Indicator?
The indicators should be incubated at a temperature of 60±2°C for accurate results.
How do I interpret the sterilization results?
A successful sterilization process will result in no color change (medium remains purple). If sterilization fails, the medium will change from purple to yellow.
What is the shelf life of these biological indicators?
The product has a quality guarantee period of two years from the date of manufacture.
Which bacterial spores are used in this indicator?
It utilizes Geobacillus stearothermophilus (ATCC 7953) spores, which are the standard for steam sterilization monitoring.
Can these indicators be used for Dry Heat or ETO sterilization?
No, these specific indicators are designed only for Moist Heat (Steam) sterilization. They should not be used for ETO, dry heat, or other processes.
How long is the total incubation time required for a final readout?
While initial changes may be seen earlier, the final definitive readout should be taken after 24 to 48 hours of incubation.

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