Tıbbi Cihazların Sterilizasyonunun Proses Validasyonu için Hazırlanan Boya-Akrilamid/İtakonik Asit Jel Dozimetresi

Amaç: Bu çalışmada tıbbi cihazların sterilizasyonunun proses validasyonu için kullanılacak yeni bir polimer jel dozimetre (PGD), gama ışınları kullanılarak hazırlanmıştır. İtakonik asit, akrilamid, jelatin, farklı boyalar [metilen mavisi, metil turuncusu ve kristal mor (KM)] ve oksijen tutucu olarak N, N’-metilenbisakrilamid ve askorbik asitten oluşan yeni polimerik sistemler üzerinde çalışılmıştır. Gereç ve Yöntem: Hazırlanan yeni PGD dozimetre formülasyonlarındaki farklı boyaların doz hız sabitleri ve radyasyon kimyasal verimleri üzerindeki etkisi, birçok tıbbi cihaz, farmasötik ürün ve biyolojik dokunun ultraviyole kullanılarak sterilizasyonu için tipik olan 7-28 kGy yüksek doz aralığında spektrofotometre yöntemi ile araştırılmıştır. Bulgular: Hazırlanan PGD dozimetrelerinin spektrumu, numunelerin gama ışıması üzerine bir değişikliğe uğraması ve mavi jel renginin ağartılması, radyasyon dozu ile artar; tıbbi cihazın sterilizasyon dozunda (25 kGy) bile, ışınlanmamış KM-PGD’nin koyu mavi rengi neredeyse renksiz olana dönmüştür. Işınlanmamış ve ışınlanmış PGD dozimetrelerinin tepkisi, 60 günlük saklama süresi boyunca oldukça kararlıdır. Sonuç: Hazırlanan boya-PGD dozimetrelerinin yüksek doz gerektiren radyasyon proses uygulamalarında, örneğin; tıbbi cihazlar ve sağlık bakım ürünlerinin sterilizasyonunun proses validasyonunda faydalı olacağı kanaatindeyiz.

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

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 28kGy-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 (25kGy), the dark blue color of the non-irradiated CVPGD 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.

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