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EO Biological Indicators
EO Biological Indicators
Medi Gases delivers high-quality Self-Contained Biological Indicators (SCBIs) designed to ensure the effectiveness of EO/EtO (Ethylene Oxide) sterilization processes.
These indicators feature bacterial spores on a paper carrier, housed in a durable thermoplastic culture tube for ease of use and accuracy. Ideal for validating sterilization cycles, they provide a reliable, efficient, and compliant solution for verifying the sterility and safety of your products across various industries.
- Designed for Ethylene Oxide (EO) sterilization validation
- Contains Bacillus atrophaeus spores for accurate monitoring
- High population spores for reliable sterility assurance
- Complies with ISO 11138 and international sterilization standards
- Suitable for healthcare, pharmaceutical & medical device industries
Self-Contained Biological Indicators for EO/EtO Sterilization
Medi Gases offers reliable and easy-to-use Self-Contained Biological Indicators (SCBIs) to monitor the effectiveness of your EO/EtO (Ethylene Oxide) sterilization processes. Our biological indicators contain bacterial spores on a paper carrier, packaged within a thermoplastic culture tube, offering a simple yet accurate method to verify the sterility of your products.
SHow It Works
Each Self-Contained Biological Indicator includes a sealed glass ampoule containing a specially formulated soybean casein digest culture medium. The medium is equipped with a color indicator that changes to yellow when bacterial spores are killed during the sterilization process.
Procedure:
- Placement: Simply place the biological indicator inside your products or product packages before sterilization.
- Sterilization: Place the “inoculated package” in the EO/EtO sterilizer and process according to your standard procedures.
- Activation: After sterilization, remove the biological indicator and “activate” it by crushing the soft plastic culture tube. This action breaks the glass ampoule, allowing the medium to mix with the spores.
- Incubation: Place the activated biological indicator in an incubator for:
- Steam sterilization: 24 hours at 35–39°C
- EO/EtO sterilization: 48 hours at 35–39°C
- Result: If any spores survive the sterilization process, the culture medium will turn yellow, indicating the presence of viable organisms. If no growth is detected, the sterilization process has been successful.
Key Features
- Easy-to-Use: Provides a simple visual result in just 24–48 hours without the need for laboratory transfers.
- Quick and Reliable: Monitors EO/EtO sterilization with accuracy, giving fast results that are easy to interpret.
- Non-invasive: No need for complicated handling or laboratory testing — the process can be done directly in the sterilization area.
Product Specifications
- Organism Used: Bacillus Atrophaeus (Subtilis var. Niger) 10E6
- Sterilization Process: EO Gas
- Incubation Time: 48 hours
- Incubation Temperature: 35 – 39°C
- Reorder Number: SBI-E6