Reliable Self-Contained Biological Indicator with 48 Hours Incubation Time

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Product Description

Basic Information
Model NO.
EZ-6
Certification
CE, ISO13485
Material
Liquid
Incubation Time
48h
Period of Validity
1 Year
Change in Color
Green to Yellow
Culture Temperature
33-37℃
Origin
China
Product Description

Ethylene Oxide Sterilization Self-contained Biological Indicator

This product uses Geobacillus stearothermophilus ATCC 9372 (formerly Bacillus stearothermophilus var. niger) as the indicator strain. It consists of a bacterial strip, a recovery medium (sealed in a glass tube), and a plastic outer casing.

The bacterial spore content is ≥1.0×10⁸ cfu/unit. Under conditions of 54±1ºC, relative humidity 60±10%RH, and 100% pure EO concentration of 600±30mg/L, the D-value is ≥2.0 minutes.

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Scope of Application & Method of Use

Suitable for monitoring the effectiveness of ethylene oxide sterilization processes.

  • Place the required number of biological indicators at the designated positions in the sterilizer in accordance with the determined sterilization process requirements.
  • After sterilization, press the indicator cover to close the air hole on the side of the cover, and quickly use a special plastic clamp to squeeze the plastic tube of the indicator, breaking the glass tube inside the plastic tube to confirm that the bacterial strip is completely immersed in the culture medium.
  • Incubate vertically in an incubator at 33ºC~37ºC. At the same time, take an unsterilized indicator, process it according to the above method, and incubate it together as a positive control tube.
  • After 48 hours of incubation, determine the result: if the color changes from original green to yellow, the indicator is positive; if it remains green, it is negative.
Important Notes
  • Biological monitoring results are only valid when the positive control tube shows a positive reaction (color change from green to yellow).
  • Before use, confirm the product is intact, the lid is not closed, and allow it to return to room temperature.
  • Store at a temperature of 4ºC~25ºC with a relative humidity of 30%~70%.
  • Keep away from sterilants, avoid direct sunlight and ultraviolet radiation, and do not freeze.
  • Use within the validity period (one year from production).
  • Sterilize and discard positive biological indicators and invalid discarded biological indicators after use.
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Production Facility
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Frequently Asked Questions
Are you a manufacturer or trader?
We are a direct factory covering an area of 20,000 square meters, equipped with professional technical engineers and specialized workshop teams.
Can you provide overseas service?
Yes, after the equipment arrives at your facility, we can arrange for engineers to assist with installation and operator training.
How do you guarantee product quality?
We ensure 100% qualified products before delivery. We offer a 1-year warranty and provide lifetime support for spare parts.
What payment terms do you support?
We support multiple payment methods including T/T, L/C, and Western Union.
Do you support customized services?
Yes, we can design and manufacture equipment and specifications according to your specific requests.
Is it possible to visit the factory?
Absolutely. We highly welcome clients to visit our facility; it is our honor to host you and show our production process.

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