PDA TR11_伽玛射线灭菌_Sterilization by Gamma Radiation_1988.pdf

Sterilizationof Parenterals by Gamma Radiation 注射用药物伽马射线灭菌 MICROBIOLOGY SUB-COMMITTEE RADIATIONSTERILIZATIONTASK FORCE 微生物学小组委员会放射灭菌工作组 Introduction 简介 The United States Pharmacopeia recognizes five distinct methods of sterilization: steam, dry heat, ethylene oxide, filtration, and ionizing radiation (1). A sterilization method is selected based upon the specific characteristics of the product and process of manufacture. The selection requires knowledge of the sterilization process, the equipment required, as well as information regarding the physical, chemical, and functional compatibility of the product and its package with the sterilization process. The sterilization process must achieve the desired sterility assurance level and maintainthe productstotalquality attributes. 5 美国药典认可的 种不同灭菌方法：蒸汽 1 灭菌，干热灭菌，环氧乙烷灭菌，过滤灭菌和电离辐射灭菌 （）。灭菌方法是根据产品 和生产工艺的具体特点来选择的。选择时需要了解灭菌工艺知识，所要求的设备以及物 理，化学和功能兼容性的信息和无菌工艺的包装信息。灭菌工艺必须达到期望的无菌保 证级并维持产品的总质量属性。 This paper provides general information concerning development and validation of gamma sterilization processes employing cobalt-60 and cesium-137 isotopes as a source of ionizing radiation. Particular attention is paid to the development and validation of sterilization processes for health care products at contract radiation facilities. Where a manufacturer has internal irradiation capability, the separate responsibilities of the radiationcontractorand pharmaceuticalfirmare combinedwithin a single organization. This document assumes that an outside contractor will be employed inorderto more clearly delineate the individual obligations of each party. 60 本文提供了伽马射线灭菌工艺的开发和验证的总体信息，该工艺采用钴 和同位素铯 137 作为电离辐射源。要特别注意辐射设施中保健产品灭菌工艺的开发和验证。如果生 产商具有内辐照能力，放射承包商和制药公司的各自责任融合在一个单独组织中。该文 件假设雇佣外部承包商，以便更清楚地描述每一方的责任。 The ab