The Preparation of Dye-Acrylamide/Itaconic Acid Gel Dosimeters for Process Validation of Medical Device Sterilization

Abstract

Aim:In this study, a new polymer gel dosimeter (PGD) was prepared using gamma rays for process validation of medical device sterilization. New polymeric systems were studied, consisting of itaconic acid, acrylamide, gelatin, different dyes [methylene blue, methyl orange and crystal violet (CV)] and N,N’-methylenebisacrylamide, with ascorbic acid as an oxygen scavenger.Materials and Methods:The study investigated the effect of the different dyes in the newly prepared PGD dosimeter formulations on the dose rate constants and radiation chemical yields in the high dosage ranging from 7 to 28 kGy-typical for the sterilization of many medical devices, pharmaceutical products and biological tissue-by using a ultraviolet-visible spectrophotometer method.Results:The sample spectrums of the prepared PGD dosimeters underwent a change following gamma irradiation, and bleaching of the blue gel color increased with the radiation dose. Even at the sterilization dose for medical devices (25 kGy), the dark blue color of the non-irradiated CV-PGD became almost colorless. The response of non-irradiated and irradiated PGD dosimeters remained stable during a storage period of 60 days.Conclusion:The prepared dye-PGD dosimeters are therefore suitable for use in monitoring various high dose radiation-processing applications, which can be useful for many medical devices and healthcare products.

Keywords

• dosimeter
• gamma ray
• radiation
• sterilization