Super Rapid Biological Indicator Steam Sterilization - Miracle Industries

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Super Rapid Biological Indicator Steam Sterilization - Miracle Industries

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Product Description

Basic Information

Sterilization

Without Ethylene Oxide

Guarantee Period

Two Years

Logo Printing

Available

Sterile Method

Eo or Steam

Bacteria Type

G. Stearothermophilus

OEM/ODM

Available

Transport Package

25PCS/Box

Capacity

250,000 PCS/Day

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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 viable Geobacillus stearothermophilus (ATCC 7953) spores. If successful, the color remains unchanged.

Precautions:

Do not use for ETO, dry heat, formaldehyde, or hydrogen peroxide processes.
For single use only; do not reuse the biological indicators.
Complies with ISO 11138-1:2017 and ISO 11138-3:2017 standards.

Product Name	Self-contained Biological Indicator for Moist Heat Sterilization
Indicator Bacteria	G. stearothermophilus, ATCC7953
Spore Population	≥1.0×10⁵ cfu
D-Value	≥1.5min (at 121ºC saturated steam)
Incubation Time	48h (Final readout at 24-48h)
Certificates	ISO13485

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Frequently Asked Questions

What is the indicator organism used in this product?

The indicator uses Geobacillus stearothermophilus (ATCC 7953) spores, which are highly resistant to moist heat sterilization.

How long does the incubation take?

The standard incubation time is 48 hours at 60±2°C, with initial readouts possible after 24 hours.

How do I interpret a positive result?

A positive result is indicated by a color change from purple to yellow, signifying that sterilization was not successful.

Can these be used for Ethylene Oxide (EO) sterilization?

No, these specific indicators are designed for Moist Heat/Steam sterilization only. They should not be used for ETO, dry heat, or plasma sterilization.

What is the shelf life and storage condition?

The quality guarantee period is two years when stored according to recommended medical storage standards.

Are OEM services available for packaging?

Yes, both OEM and ODM services are available to meet specific customer branding and packaging requirements.