What sterilization processes is this indicator suitable for?

It is designed specifically for steam sterilization processes and should not be used for ETO, dry heat, formaldehyde, or hydrogen peroxide.

How do I interpret the test results?

A color change from purple to yellow indicates a positive result (viable spores), while no color change indicates a negative result (successful sterilization).

Can I reuse the biological indicator?

No, the biological indicators are single-use only and must not be reused.

Is OEM or ODM service available?

Yes, OEM and ODM services are available for this product.

Steam Biological Indicator

Zhucheng Binfei Medi-Tek Co., Ltd.

5 yrs

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Product Highlights

Specific Sterilization Monitoring: Specially designed for monitoring steam sterilization processes only.
Clear Visual Result: Color changes from purple to yellow if spores are viable after incubation.
Standard Compliance: Complies with ISO 11138-1:2017 and ISO 11138-3:2017 standards.
OEM and ODM Available: Customization options available for sterile method and bacteria type.
Quality Guarantee: Two-year quality guarantee period provided for the product.
Certified Manufacturer: Manufacturer holds ISO 13485 certification for medical devices.
Complete Indicator Kit: Includes ampoule, spore disc, chemical strip, and filter paper.

Product Attributes

Customization: Available
Type: Sterilization Materials
Material: Geobacilus Stearothermophilus (Atcc 7953) Spores
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: Available
ODM: Available
Content: Chemical Indicator Strip
Transport Package: 25PCS/Box
Specification: ATCC7953
Trademark: BINFEI
Origin: China
HS Code: 3002493090
Production Capacity: 250000PCS/Day

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Product Description

BinFei®Bl6 Steam Biological indicator is specially designed for monitoring steam sterilizationprocesses. lf the sterilization process is unsuccessful, after incubation at 60+2'Cthe color of themedium will change from purple to yellow or its shades, indicating the presence of stil viable Geobacilus 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 incubafion at 60+2°C.

Do not use BinFei®Bl6 Steam Biological indicator for ETO, dry heat, formaldehyde.hydrogen peroxide and other sterlization processes.
Do not reuse the biological indicators.

Steam Biological indicator
in compliance with
ISO 11138-1:2017
ISO11138-3:2017

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 (Test condition:saturated steam 121ºC)
Incubation Time:	48h
Result: Interpretation:	Color Change in Bioassay culture medium: positive; No Color Change: negative
Manufacturer	Zhucheng Binfei Medi-Tek Co.,Ltd
certificates	ISO13485

Content

BinFei®BI6 Steam Biological indicator consists of medium in a glass ampoule, a discinoculated with Geobacillus stearothermophilus (ATCC 7953) spores, a chemical indicatorstrip,a plastic tube,a plastic cap, and a filter paperinside the cap

WE HAVE OWNED OURSELVES FACTORY IN 2015, THERE ARE 100 SQUARE METERS IN HEFEI OFFICE AND 100000 SQUARE METERS IN SHAN DONG FACTORYIS ONE OF THE MOST PROFESSIONAL DISPOSABLE DENTAL PRODUCTS' SUPPLIER IN CHINA.

For now, we can supply :
sterilization pouches & rolls, dental bibs, saliva ejectors, mixing tip, face masks, surgical gowns, face shield, dental kit, cheek tray, polishing brush, micro brush applicator, barrier film, alcohol pad swab, oral foam swab, mob clip cap, surgical blade, dental Irrigation needle, dental anaesthesia needle, Ortho prosthesis box, cotton roll, air water tip, dental Dappen cup, Endo measure block, mixing tip, Prophylaxis Brushes, cheek retractors, mouth gags open my mouth, Impression tray, Dental Wedge, Mixing spatula, Dental kits(more in one), Medical face shield, Goggles, spectacle face visor, all kind of shoe covers and gowns, Plastic Tray, alginate, Endo Ring Foam Refill .

Steam Biological Indicator

Looking forward to cooperating with you in the future ......

About the Supplier

Company Profile

Zhucheng Binfei Medi-Tek Co., Ltd., As a reliable manfuacturer, we provide OEM service with very good quotation, price is very competitive, meanwhile high quality is our life, no matter what happened we're always responsable for our goods forever, our products had been exported to EU, the UK, Middle East, USA, South America, Southeast Asia, you can rest assured that all cargo will be shipped to you fluently. CE, ISO and other certificates test reports can be offered, we'll do our best to support you for registering. We're specilized on medical disposable products, especially Personal Pretective Equipment, sterilization products and dental consumables. Once you cooperate with us, we will offer 24hrs service for your orders, also update processes in time, our workers are very professional and works very fast, they help us give you faster leading time, your goods will be shipped out on time. No matter where you are from, our logistics department can offer you the most cheapest shipping cost for your reference, try our best to reduce your purchase cost, at the same time, EXW, DAP, FOB, CIF, DDP is available for trade terms, assist you deal with all kinds of barriers of importing&purchasing. In a word, we provide you High Quality, better price, faster production, cheap freight, safety transaction, more supports for your business, sincerely looking forward to cooperating with your team.

We aim to provide best OEM service, best price and the shortest leading time for our customers!

We adhere to the management principles of "quality first, customer first and credit-based" since the establishment of the company and always do our best to satisfy potential needs of our customers. Our company is sincerely willing to cooperate with enterprises from all over the world in order to realize a win-win situation since the trend of economic globalization has developed with anirresistible force.

About Our Factory & Business Background

Address: Sunjia Bashan Village, Changcheng Town, Weifang, Shandong, China
Terms of Payment: LC, T/T, D/P, Western Union
International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, FAS, DDP, DAP, FCA
Average Lead Time: Peak Season Lead Time: one month
Off Season Lead Time: within 15 workdays
Nearest Port: Qingdao, Shanghai

Our Production Capability & Technical Expertise

Main Products: Dental Bibs, Sterilization Pouch, Shoe Cover, Clip Cap, Saliva Ejector, Dental Consumables, Oral Swab, Alcohol Pad, Disposable Face Masks, Dental Needle

Our Industry Experience & Global Business Record

Export Year: 2018-05-01
Main Markets: North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe

FAQ

What sterilization processes is this indicator suitable for?: It is designed specifically for steam sterilization processes and should not be used for ETO, dry heat, formaldehyde, or hydrogen peroxide.
How do I interpret the test results?: A color change from purple to yellow indicates a positive result (viable spores), while no color change indicates a negative result (successful sterilization).
Can I reuse the biological indicator?: No, the biological indicators are single-use only and must not be reused.
Is OEM or ODM service available?: Yes, OEM and ODM services are available for this product.
What is the packaging quantity?: Each pack contains 25 units.