Before the process of radiation sterilization of medical devices, it is necessary to establish and record important technical parameters of the process in the instructions for radiation treatment (sterilization dose, irradiation time, conveyor speed, etc.). At the next stage, test sterilization of samples is carried out, proving that the selected parameters provide the required level of sterility and the medical device does not change its properties.

The average dose for sterilization by radiation is 25 kGy (2.5 Mrad), the choice of this value is justified using microbiological tests. Periodic checks are carried out to confirm the effectiveness of the dose, including an audit of the sterilization dose.

 

The effectiveness of sterilization of medical devices with gamma radiation also depends on the way the products are stacked. For each type of product, an instruction is approved, including a description of the packaged product (dimensions, density, permissible changes in these parameters, orientation of the product in the package), a description of the method of placing products in the irradiation container, a description of the irradiation container and its dimensions.

The development, validation and routine control of the gamma radiation sterilization process is only allowed for those participants whose
competence is confirmed by appropriate training and qualifications.

The definition of their authority and responsibility is documented in quality management systems. Process monitoring includes monitoring of process equipment, product movement before, during and after irradiation, routine and preventive maintenance, regular calibration of timers and dosimeters, routine dosimetry monitoring, process continuity and record keeping.

Radiation sterilization of medical devices, especially when it comes to gamma radiation, is a safe process while meeting the requirements of industry standards. We cooperate with accredited sterilizing centers that carry out ion sterilization activities.