RADIATION STARILIZATION: 2-RADIATION STERILIZATION OF DRUGS

Güldem OLGUNER*, A.Yekta ÖZER*°

*Hacettepe University, Faculty of Pharmacy, Departemant of Radiopharmacy, 06100 Sihhiye, Ankara, TURKEY.
°Corresponding Author

Summary:
Gama sterilization is the most convenient method for the sterilization of pharmaceutical raw materials, pharmaceutical dosage forms or controlled release drug delivery systems that are not sterilized with conventional sterilization techniqus because of thermal instability or toxic residue.
Sterilization of the product in finished from, easy validation and determination of the radiation dose absorbed by the product by dosimetry are the advantages of radiation sterilization.
Before sterilization of the product, the radiation stability of the product must be determined. Therefore before the sterilization of the product with gamma rays, physical, chemical and physicochemical, microbiological and biological properties of the product should be determined and after sterilization changes in these properties must be evaluated.
Minimum radiation dose which will provide acceptable chemical activity loos and efficient sterilization should be determined before sterilization.
Pharmaceutical dosage forms that can be sterilized with gamma rays are: Thermally unstable pharmaceutical dosage forms, sterile injectable powders, aqueous solutions, aqueous suspensions,oily solutions,oily suspensions W/O or O/W ophtalmic ointments, ophtalmic suspensions in oil and/or aqueous vehicle, natural or synthetic polymeric raw materials, microspheres, nanospheres microcapsules and nanocapsules.

Key words:
Sterilization, Radiation sterilization, Terminal sterilization , Sterile product.