China Biological Indicator for Steam Sterilization Factory and

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China Biological Indicator for Steam Sterilization Factory and

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Product Description

Basic Information

Model NO.	BF-B16	Ethylene Oxide Sterilization	Without Ethylene Oxide Sterilization
Quality Guarantee Period	Two Years	Group	All
Logo Printing	With Logo Printing	Sterile	Eo or Steam
Bacteria	G. Stearothermophilus	Method	Moist Heat Sterilization
OEM/ODM	Available	Transport Package	25PCS/Box
Specification	ATCC7953	Production Capacity	250000PCS/Day

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.

Do not use for ETO, dry heat, formaldehyde, hydrogen peroxide and other sterilization processes.
Do not reuse the biological indicators.
In compliance with ISO 11138-1:2017 and ISO 11138-3:2017 standards.

Product Name	Self-contained Biological Indicator for Moist Heat Sterilization
Units per Pack	25 pcs/box
Indicator Bacteria	G. stearothermophilus, ATCC7953
Spore population	≥1.0×10^5 cfu
D-Value	≥1.5min (Condition: saturated steam 121ºC)
Incubation Time	48h
Interpretation	Color Change: positive; No Color Change: negative
Certificates	ISO13485

Content: 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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Company Profile

Established in 2015, we operate extensive factory facilities totaling over 100,000 square meters. We are recognized as one of the most professional suppliers of disposable dental products in the industry.

Currently, our product range includes: sterilization pouches & rolls, dental bibs, saliva ejectors, mixing tips, face masks, surgical gowns, face shields, dental kits, polishing brushes, barrier film, alcohol pads, oral foam swabs, and various other surgical and dental consumables.

Our Advantages

Looking forward to cooperating with you in the future!

Frequently Asked Questions (FAQ)

How do I interpret the results of the biological indicator?

After incubation, a color change from purple to yellow indicates a positive result (unsuccessful sterilization). If the color remains original (purple), the result is negative, indicating successful sterilization.

What is the required incubation temperature and time?

The indicator should be incubated at 60±2°C. While initial results may appear sooner, the final readout should be taken after 24 to 48 hours.

Can these indicators be used for Dry Heat or ETO sterilization?

No, these specific indicators are designed for moist heat (steam) sterilization only and should not be used for ETO, dry heat, or formaldehyde processes.

What standards do these biological indicators comply with?

They are manufactured in compliance with ISO 11138-1:2017 and ISO 11138-3:2017 international standards.

What is the shelf life and storage capacity?

The product has a quality guarantee period of two years. Our factory has a high production capacity of approximately 250,000 pieces per day to ensure steady supply.