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Sterilization and decontamination
An infrastructure and services tailored to every need.
Our services cover :
- Packaging
- Ethylene oxide sterilization
- Ethylene oxide decontamination
- Validation of sterilization/decontamination processes in accordance with ISO 11135
- Storage and distribution
We can adapt the parameters of your cycles to your specific needs:
- Ethylene oxide concentration
- Temperature
- Relative humidity
- Gas contact time control
- Gas pressure
An obvious choice
Our advantages in sterilization
- Over 35 years of accumulated expertise
- An exhaustive range of services and products dedicated to sterilization.
- Developed cycles adapted to all product types.
- Flexibility at every level.
- Possibility of developing new cycles to meet the most demanding requirements.
- Our ISO 11135 and ISO 13485 certifications.
- A team of experts to support you in your quality and development initiatives.
- The ability to sterilize a wide range of volumes, from the smallest to the largest.
Properties and mode of action
Our technical specifications
Sterilization cycle
Our chambers have double doors, to control the flow of sterile and non-sterile products.
The phases :
– packaging
– gas injection
– gas contact
– aeration
are integrated into a single cell for maximum traceability and safety.
– Vacuum cycle in a gas mixture inerted with nitrogen (non-flammable).
– ATEX zone – and appropriate protective equipment for optimum employee safety.
Sterilization process
We sterilize our products using ethylene oxide. The aim of our sterilization process is to inactivate the micro-organisms present on medical devices.
In order to market a sterile product, a sterility assurance level of 10-6 is required.
Ethylene oxide sterilization is widely used to process medical devices.
The process is suitable for heat-sensitive products such as syringes, dressings and tubing.
Action of ethylene oxide
The special feature of ethylene oxide sterilization is that it is carried out at low temperatures between 30 and 60°. This prevents any alteration or deformation of the products.
This gas spreads through the products to destroy any micro-organisms present. For perfect sterilization, OE can pass through several layers of packaging.
Depending on the composition and density of the products, it is necessary to adapt the cycle time, temperature, humidity and gas concentration.
Decontamination
We also offer ethylene oxide decontamination treatment for non-MD products such as piercings and other accessories.