Tıbbi ürünlere endüstriyel skalada uygulanan sterilizasyon proseslerinin incelenmesi
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Date
1988-01
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Türkiye Atom Enerjisi Kurumu, Çekmece Nükleer Araştırma ve Eğitim Merkezi
Abstract
Tıbbi ürünlerin endüstriyel ekalada sterlllzasyonu İçin halen uygulanan kuru sıs, nemli ısı, etilen oksit ve radyasyon sterilizasyonu yöntemleri mukayese edilmiş ve herhir prosesi etkileyen faktörler ile avantaj ve dezavantajları tartışılmıştır. Sterllizasyon proseslerinin etkinlikleri inaktlvasyon faktörlerl ile ifade edilmiş ve radyasyon sterilizasyonunun patojenler dahil birçok mikroorganizmaya karşı güvenlik faktörünün yüksek olduğu gösterilmiştir. Etilen oksit ile steril edilen ürünlerde, sterllizasyon sırasında oluşan etilen klorohidrin ve etilen glikol riziduleri İçin limit değerler verilmiştir. Etilen oksit ve bu rezidtilerln tehlikeli, tokslk ve canlı organizmalar üzerindeki mutajenlk etkisi vurgulanmış ve neden oldukları toksik reaksiyonlardan bazı örnekler verilmiştir. Ayrıca, etilen oksit sterillzasyon prosesi için bazı ülkelerde getirilen kısıtlamaların proses maliyetini arttırdığı belirtilmiştir.
Radyasyon sterilizasyonunun dünyadaki durumu ve bu alanda son yıllarda kaydedilen gelişmeler gösterilmiştir. Ayrıca radyasyonla steril edilen tıbbî ürün ve gereçler ile farmasötlk endüstrisinde kullanılan malzeme ve hammaddelerden örnekler verilmiştir. Radyasyon sterllizasyon tesislerinin bileşenleri ile ilgili kısa bir bilgi verilmiş ve bu tür tesislerin ülkemizde de kurulmasının gerekliliği vurgulanmıştır.
Methods of dry heat, moist heat, ethylene oxide and radiation, which are presently applied in industrial scale for the sterilisation of medical products, have been compared and factors affecting each process were given. Their advantages and disadvantages have been also discussed.The effectiveness of each sterilisation process is expressed as inactivation factor. It was shown that for radiation sterilisation, inactivation factors are sufficiently high to offer a high safety factor against many common micro-organisms including pathogens. The permissible limits for ethylene oxide, ethylene glycol and ethylene chlorohydrin in ethylene oxide sterilised products were given. The toxic and mutagenic effects of ethylene oxide and other residues on living organisms have been emphasized. Examples of the toxic reactions caused by ethylene oxide sterilised products were given. It is pointed out that the restrictions brought in some countries for ethylene oxide process increase the process cost. The worldwide status of radiation sterilisation and recent developments in this field were shown. Examples of medical products and supplies with substances and raw materials used in pharmaceutical industry, which are currently being sterilised by radiation were given. A brief information on the components of irradiation plants were given and the need for construction of these plants in Turkey have been strongly eiaphasized.
Methods of dry heat, moist heat, ethylene oxide and radiation, which are presently applied in industrial scale for the sterilisation of medical products, have been compared and factors affecting each process were given. Their advantages and disadvantages have been also discussed.The effectiveness of each sterilisation process is expressed as inactivation factor. It was shown that for radiation sterilisation, inactivation factors are sufficiently high to offer a high safety factor against many common micro-organisms including pathogens. The permissible limits for ethylene oxide, ethylene glycol and ethylene chlorohydrin in ethylene oxide sterilised products were given. The toxic and mutagenic effects of ethylene oxide and other residues on living organisms have been emphasized. Examples of the toxic reactions caused by ethylene oxide sterilised products were given. It is pointed out that the restrictions brought in some countries for ethylene oxide process increase the process cost. The worldwide status of radiation sterilisation and recent developments in this field were shown. Examples of medical products and supplies with substances and raw materials used in pharmaceutical industry, which are currently being sterilised by radiation were given. A brief information on the components of irradiation plants were given and the need for construction of these plants in Turkey have been strongly eiaphasized.
Description
TENMAK D.N.. 7707
Keywords
Medical instruments and apparatus -- Sterilization, Tıbbi aletler ve cihazlar -- Sterilizasyon, Medical supplies -- Sterilization, Tıbbi sarf malzemeleri -- Sterilizasyon
Citation
Erkol, A. Y. (1988). Tıbbi ürünlere endüstriyel skalada uygulanan sterilizasyon proseslerinin incelenmesi. İstanbul : Türkiye Atom Enerjisi Kurumu, Çekmece Nükleer Araştırma ve Eğitim Merkezi.