Guide for radiation sterilization of pharmaceuticals and decontamination of raw materials

Detection of Structural Defect in Methoxymethyltriphenylphosphonium Chloride Single Crystal by Electron Paramagnetic Resonance

“…sonucunda gıdalarda organik serbest radikaller oluşur [11]. Uygulanan bu işlemler arasında özellikle gama ışınlaması ilaç, tıbbi malzemeler ve gıdaların sterilizasyonu ve dayanıklılık süresinin uzatılması için sıklıkla kullanılır [12]. Gama ışınlaması, ilaç, antioksidan, vitamin ve gıdalarda serbest radikal oluşumuna sebep olabilir.…”

Ionizing Radiation Used in Drug Sterilization, Characterization of Radical Intermediates by Electron Spin Resonance (ESR) Analyses

“…Irradiated drug/drug raw materials are also completely safe to use immediately after sterilization process [2,3,10,14,18]. Because of these advantages, sterilization by ionizing radiation, especially gamma radiation, has been successfully applied in many countries [13,21,22]. EN 552 and ISO 11137 publications recognize standard for implementing radiation technology on sterilization [19,20].…”

“…Nevertheless, besides its advantages, radiosterilization also has some drawbacks. Radiation cannot only eliminates microorganisms included in pharmaceuticals but also can cause a molecular decrease in the amount of active drug by destroying it and, therefore, creating reactive molecular fragments which may result in a toxicological hazard [2,5,18,[21][22][23][24]. Although the radiolytic products induced upon irradiation are generally in very small quantities [14], the characterization of the radio-induced radicals is very important and necessary, both to determine the feasibility of the radiation treatment and to control it.…”

Influence of e-Beam Irradiation on Sulfamethoxazole in Solid State

“…Pharmacopoeias recommend many methods of sterilization, but the optimum is that by irradiation. 4,5 The problem is to check if irradiation of a given therapeutic substance does not change its properties that could affect the pharmacological effect, so practically each substance should be tested for the possibility of irradiation sterilization. In particular, the tests should permit us to establish the doses that would have strong enough sterilizing effect but would not damage the therapeutic activity of a given substance.…”