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Sterilization with ethylene oxide, known under the abbreviations OE and OET (EO and ETO in English), is the European method having general compatibility with a large number of materials, resins and types of medical instruments. Through a gas diffusion process, ethylene oxide can sterilize the products and eliminate any viable microorganism. We use this method for its efficiency and environmental performance. PAMA has chosen to use an absorption system with an efficiency of 99.95% rather than using a catalytic burner, which represents normality in the industry, and the combustion of hydrocarbons associated with it. .
OE sterilization is suitable for:
Polymer resin products;
Single-use medical devices;
External terminal sterilization of sealed devices combining a device and drugs (filled syringes, impregnated stents).
Why use this process?
It sterilizes at low temperature, which guarantees the integrity of the product and the packaging;
It effectively sterilizes a wide range of polymers of resins, natural materials and metals, as well as products combining drugs and devices that require sterilization of the surface by external contact;
It constantly meets product and regulatory requirements;
It effectively sterilizes a wide range of products with different variations in dosage requirements, densities and package sizes;
It allows parametric release of the products directly after the treatment, which results in a reduction in the waiting time to speed up the time to market.
Would you like to know how EO sterilization services can be applied to your products?
Consultation and training
We offer a consultation and training service on request. This service is offered to companies that are just starting out on the market and who need support at the regulatory level and at the level of medical market standards.
More specifically, we are able to support you on the following points:
Health Canada medical device establishment licenses.
ISO 14644-1: 2015 Class 7 - Clean rooms and associated controlled environments - Part 1: Classification of particulate air cleanliness.
ISO 13485: 2016 (Expected Q4 2020) - Medical devices - Quality management systems - Requirements for regulatory purposes.
ISO 11135: 2014 (Expected Q4 2020) - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Development of sterilization cycles
Validation of sterilization cycles (in accordance with DIN EN ISO 11135)
Performing routine sterilization
ISO 14971: 2019 Application of risk management to medical devices
DEL (Drugs Establishment Licenses) Note: the request is being evaluated by Health Canada
21 CFR Part 820 (Expected Q4 2020) - Regulation of the quality system.