3 Hour Rapid Readout Biological Indicator for Steam Sterilization

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Product Description

📁 Basic Information
Model NO.
BF-B16
Sterilization
Eo or Steam
Quality Guarantee
Two Years
Indicator Bacteria
G. Stearothermophilus
Method
Moist Heat Sterilization
OEM/ODM
Available
Specification
ATCC7953
Production Capacity
250,000 PCS/Day
📝 Product Description
Biological Indicator Main View

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 successful, there will be no color change.

  • Compliance with ISO 11138-1:2017 and ISO11138-3:2017 standards.
  • Results interpretable within 24-48 hours.
  • Do not use for ETO, dry heat, formaldehyde, or hydrogen peroxide processes.
  • Single-use only; do not reuse.
Product NameSelf-contained Biological Indicator for Moist Heat Sterilization
TypeBF-BI4
Units per Pack25 pcs/box
Indicator BacteriaG. stearothermophilus, ATCC7953
Spore Population≥1.0×10⁵ cfu
D-Value≥1.5min (at saturated steam 121ºC)
Incubation Time48h
Result InterpretationColor Change: Positive; No Color Change: Negative
CertificatesISO13485
🔍 Content & Structure

The Biological indicator consists of a medium in a glass ampoule, a disc inoculated with spores, a chemical indicator strip, a plastic tube, a plastic cap, and a filter paper inside the cap.

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📸 Detailed Photos
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📦 Packaging & Shipping
Packaging Box
🏥 Other Medical Consumables
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📜 Certifications
Cert 1
Cert 2
🏢 Manufacturing Profile
Factory Interior

One of the most professional disposable medical and dental products' suppliers, providing sterilization pouches, bibs, saliva ejectors, masks, and surgical gowns.

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Our Advantages
❓ Frequently Asked Questions
How do I know if the sterilization was successful?
After incubation, if the medium remains its original purple color, the sterilization was successful. If it turns yellow, it indicates the process failed.
What is the required incubation temperature and time?
The indicators should be incubated at 60±2°C. The final readout for the BF-BI4 model should be taken after 48 hours.
Can these indicators be used for dry heat sterilization?
No, these specific biological indicators are designed only for steam (moist heat) sterilization processes.
What standards do these products comply with?
They are in full compliance with international standards ISO 11138-1:2017 and ISO 11138-3:2017.
What is the shelf life of the biological indicators?
The product has a quality guarantee period of two years from the date of manufacture.
Is OEM service available for this product?
Yes, both OEM and ODM services are available to meet specific branding and packaging requirements.

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