Validation Process

Radiation Sterilization: Safety in three steps

Sterility means that a product is free from microorganisms capable of reproduction. In technical manufacturing processes, this is only possible up to a point. Therefore the Standard EN 556 on medical devices requires that for a product to be described as ‘sterile’, statistically a maximum of only one in one million items may be found to contain a viable microorganism (sterility assurance level: SAL 10-6)

The validation of radiation sterilization takes place in three parts:

Microbiological Validation

In microbiological validation, the radiation dose is determined which will change a non-sterile product into a sterile one. To do this, the initial microbiological state, i.e. the numbers and types of microorganisms present, first has to be ascertained. Here we cooperate with accredited microbiological laboratories. Dependent on the bioburden and the resistance to ionizing radiation of the microorganisms found, proof is provided by irradiation that this dose can convert all parts into a sterile state.

Dosimetric Validation / Determining Dose Distribution

Dosimetric validation ensures that the defined dose is adhered to in all areas, with the given packaging and the predetermined packing arrangement. For this purpose the irradiation conditions are fixed, and the areas of the packaged product receiving the minimum and maximum doses are documented.

Application-related Validation

The manufacturer verifies that the sterilized product, including the packaging material, fulfils the required property profile over the whole shelf-life. Since the product materials are decisive in determining whether radiation sterilization can be used, our experts will be pleased to advise you already at the product development stage.