UNIQUE IN NORTH AMERICA
We have started our own ethylene oxide sterilization service within our company. The latter conforms to the ISO 11135: 2014 standard. We are now available to meet the need for sterilization of medical devices by contract.
We invite you to discover PAMA Manufacturing and Sterilization !
EO sterilization is suitable for:
Polymer resin-based products;
Single-use medical devices;
External terminal sterilization of sealed devices combining a device and drugs (filled syringes, impregnated stents).
What is EO sterilization ?
Ethylene oxide sterilization, known by the abbreviations EO or EtO, is the method having general compatibility of 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 microorganisms. 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 the norm in the industry, and the combustion of hydrocarbons associated with it.
Also, PAMA has automated their sterilization method to operate by parametrical release. This allows the sterilized load to be released immediately after a cycle and eliminated the 7 days wait of incubation time.
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 consistently meets product and regulatory requirements;
It effectively sterilizes a wide range of products with different variations of dosage, density and package size requirements;
It allows the parametric release of products directly after processing, which results in a reduction in waiting time to accelerate the time to market of the product.
Would you like to know how EO sterilization services can be applied to your products?
Write us email@example.com