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Class 5 Chemical Integrator for EtO Gas sterilization processes using 2-Color Pass/Fail results, 250/pack
Product code: C5-INTG-E
IT12
Two level Chemical Integrator, Ethylene Oxide sterilization processes
- Level 1 – Red:
- Exposure level. Indicator ink turns yellow to indicate exposition to the process, but does not ensure that the variables required to achieve the integration condition have been achieved (UNSAFE condition).
- Level 2 – Purple / brown:
- Integration level. Indicator ink turns green to indicate that the integration condition indicated in the quality certificate has been achieved. This condition consists of the kill time of a theoretical 106 Bacillus atrophaeus spore population, calculated in a BIER (Biological Indicator Evaluator Resistometer), and is called SAFE condition. Indicators 100% free of toxic heavy metals.
Features
- Purposeful Design: Engineered to chemically react with critical parameters in ethylene oxide sterilization cycles, ensuring reliable monitoring over time.
- Universal Application: Tailored for diverse sterilization needs, the indicator strip is versatile, suitable for use in packs, pouches, containers, trays, or any containment device. It independently monitors crucial parameters across various sterilization cycles.
- Global Compliance: Beyond the United States, the Integron is a two-level chemical integrator designed to monitor ethylene oxide sterilization processes worldwide, adhering to ISO 11140-1:2014 standards.
- Distinctive Indicator Levels: The chemical indicators feature two levels – Red for exposure and Purple/Brown for integration. The color-changing ink signals different stages, ensuring clarity in identifying the sterilization process status.
- Safety Assurance: The integration condition, known as the SAFE condition, is achieved when the indicator ink turns green. This condition indicates the kill time of a theoretical spore population, ensuring a secure sterilization process.
- Toxic Metal-Free: Terragene® prioritizes safety by ensuring that the indicators are 100% free of toxic heavy metals, aligning with health and safety standards.
- User-friendly Instructions: With clear instructions for use, the Integron simplifies the sterilization process. Users are guided on proper placement, sterilization cycle execution, result analysis, and reporting of any incidents.
| Process | Ethylene Oxide |
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| Packaging | 250 |
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| Initial Color | Level 1 Red, Level 2 Purple-Brown |
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| Final Color | Level 1 Yellow, Level 2 Green |
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| Indicator Type | Type 5 Chemical Indicator |
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| Regulations | ISO 11140-1 |
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Note:
For optimal readability, follow recommended storage conditions, monitoring frequency, and adhere to the expiration date mentioned on the package label. The chemical indicator's shelf life is guaranteed for five years when stored appropriately.
Instructions for Use1. Place a Integron® IT12 Chemical Integrator along with the material to be sterilized in a suitable package according to the recommended sterilization techniques. Place the indicators in those areas of most difficult access to the sterilizing agent. 2. Perform the sterilization cycle. 3. After the sterilization process has finished and evacuation/ventilation process is over, you may: A. Remove the integrator indicator taking the necessary precaution to avoid contact with the remaining sterilizing agent. B. Ventilate the load together with the integrator indicator and then perform the reading. 4. Analyze the results. If the SAFE integration condition has been reached, the sterilization process has been effective.
Precautions
Do not store the product near sterilizing agents.
Do not expose this product to Steam, Dry Heat or any sterilization processes other than EO.
Do not reuse the sterilizer until the indicator has changed into the color indicated in the product.
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