RADIATION STERILIZATION I: THE USE OF RADIATION STERILIZATION IN MEDICAL INSTRUMENTS

Fatma BERK*, A.Yekta Özer*°

*Hacettepe University, Faculty of Pharmacy, Department of Radiopharmacy, 06100 Sihhiye, ankara, TURKEY.
°Corresponding Author

Summary :
Medical instruments may be sterilised with heat, vapour ethylene oxide and radiation. In this article we review the basic principles of radiation science, radiation sources, good radiation practice, good manufacturing practice, sterility assurance level, dosage, safety and micro biology of sterilisation procedures used in medical instruments. Radiation exerts a lethal effect on microorganisms by causing DNA breakage and cross-link damage. Radioactive sources such as 60Co and 137Cs are used for radiation sterilisation and the use of 60Co is more common. The product to be sterilised must be produced according to the GMP rules and irradiated according to the GRP rules set. SAL must be chosen according to the field of use of the material and the sterilising dose is adjusted to the microbial load of the product. If this data is not reliable, a dose of 25 kGy is recommended for minimum sterilisation dose. The material to be sterilised must be produced from radiation resistant materials. Radiation sterilisation enables the product to be sterilised after packaging and the process is continuous without formation of any toxic residues. Despite requiring a higher investment at the beginning, radiation sterilisation is much more cost-effective and reliable in the long-run.

Key words:
Sterilisation, Radiation sterilisation, Sterilisation in medical instruments.