Sterilization by radiation

Suitable for heat sensitive materials and products. The manufacturer has to confirm the suitability of this method for material. Ultraviolet irradiation not acceptable.

When the manufacturer is contracting the service out to a contract acceptor, the manufacturer still has to ensure the validation status and specify the responsibilities.

Measurement of dose during procedure should be done. The dosimeters should be independent of dose rate quantitative measurement number, location and calibration time-limit

Biological indicators can be used only as additional control measure. Radiation sensitive colour discs can be used