Sterilisation

Sterilisation is the final process for a sterile product. It comes at the end of the production chain and ensures that your product is safe and ready to use over the long term. The optimum process in each case is selected depending on the product requirement and the product and packaging materials used.

We provide sterilisation services by means of gamma rays or ethylene oxide (EO) with our in-house EO sterilisation plant or at external accredited partners. If the product or the customer requires any other sterilisation-process such as steam or X-Ray, we can also offer this in cooperation with our partners.

We work exclusively on qualified equipment. The processes are carried out according to the international standardisation series ISO 11137 (sterilisation with radiation) and ISO 11135 (sterilisation with ethylene oxide).

After the sterilisation validation has been completed, a corresponding sterilisation certificate is enclosed with every delivery.

Focus on EO sterilisation

We sterilise medical devices in our own ethylene oxide sterilisation chamber with a volume of 3.3 m³, which is a fully automatic machine according to TRGS 513.

Sterilisation is carried out in accordance with ISO 11135. This sterilisation process is an overpressure method.

• This allows the use of a significantly reduced amount of ethylene oxide compared to the under-pressure method, thus reducing the risk to the environment and complying with legal requirements to reduce hazardous substances.
• Products are sterilised only with their sterile barrier systems and not with cardboard, paper or wooden pallets, ensuring greater safety for employees.
• In addition, the overpressure method allows us to sterilise electronic components without the need for extensive and time-consuming pre-testing, as there is no risk of explosion due to the ethylene oxide concentration.