Ethylene Oxide Indicators
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Documentation
Ethylene Oxide (EO) Chemical Process Indicators (CPIs): Essential Tools for Sterilisation Monitoring
Key Features and Specifications
Compliance and Performance
- Meets ISO 11140-1 standards for Class 1 Process Indicators
- Purple-to-green colour transition sensitive to:
- Time
- Temperature
- Humidity
- Presence of EO
Intended Use
- Throughput process indicators for EO sterilisation
- Not for use as sterility indicators
Product Characteristics
Shelf Life and Storage
- 24-month shelf life from ink application date
- Store at room temperature (23 ± 7°C)
- Actual shelf life may be less than 24 months at purchase
Chemical Sensitivity
- Avoid contact with acidic or basic substances
- Keep away from cleaning solutions and disinfectants
Post-Exposure Stability
- Exposed indicators remain green under proper storage conditions
Quality Assurance
- Individual packaging for each roll
- Certificate of conformance included
Safety and Disposal
- Non-odorous and non-hazardous
- Safe for disposal in general waste
- No Material Safety Data Sheet (MSDS) required per CFR 1910.1200
Additional Information
- Spec sheet available for download
EO Chemical Process Indicators offer a reliable and standardised method for monitoring Ethylene Oxide sterilisation processes in healthcare settings. Their colour-changing properties provide visual confirmation of exposure to sterilisation conditions, enhancing quality control in medical device and equipment sterilisation. The product’s design focuses on ease of use, safety, and compliance with international standards, making it an essential tool for healthcare facilities and sterilisation service providers.
EO CPIs are labelled with 24 months of shelf life and room temperature storage (23 ± 7°C). The shelf life is based on the date the indicating ink is applied to the substrate. Product may have a shelf life of less than 24 months at the time of purchase. Avoid contact or storage of indicators near substrates which are acidic or basic in nature, such as cleaning solutions and disinfectants.
Exposed indicators are stable and will remain green when stored under labelled conditions. Each roll is individually packaged with a certificate of conformance to ensure the products’ quality and consistency.
EO CPIs are non-odorous and non-hazardous to use. The printed labels are safe to dispose in general waste receptacles. No MSDS required per CFR 1910.1200.