洁净室消毒办法及方法验证研究-药事管理专业论文.docxVIP

第 第 PAGE 5 页共 61 页 浙江工业大学 工盎硕士论文 证采用仪器检测法、高效气相检测法进行研究，臭氧残留方法验证本 文采用仪器检测法进行研究，通过以上方法验证的研究，证明采用本 文的消毒办法消毒物质残留符合法规对于残留安全要求。 针对固体口服制剂车间的周部消毒办法，本文对于目前常用的消 毒剂如: 75%乙醇、 2%。新沽尔灭溶液、3%--5%的来苏儿、 1%苯盼溶液、 70%异丙醇等分别进行了消毒办法的研究，通过以上研究本文推荐使 用 75%乙醇与 2%0新沽尔灭溶液交替使用来达到固体口服制剂车间的 局部消毒要求。为了论证消毒办法有效性，本文对消毒效果进行了验 证。消毒效果验证本文采用了表面污染试验方法来进行研究，通过以 上消毒效果的研究，证明本文介绍的消毒方法对本车间的消毒能够达 到法规要求，并且本文推荐一种消毒剂 t 异丙醉，通过消毒后的效果 来论证此消毒剂的有效性及其对环境及药品不带入二次污染的优越 性、安全性。本企业正在试用及推广过程中。 关键词洁净室，消毒办法，方法验证， t... 、. 浙江工业大学 工盔研士论文 THE ASEPTIC PROCESSING STUDY AND STERILIZING EFFECT VALIDATION IN CLEAN AREA ABSTRACT Since GMP regulations on the environmental monitoring in clean area of pharmaceutical production (especially the manufacturing of sterile drug products) have a very strict control requirement ，it is more important how to control the microbial limits and minimize the contaminants risk in the manufacturing of sterile products. Beside the sterile filtration and the final sterilization that can directly control the microbial bioburden to remove the microbial contaminants in the final products，minimizing the contaminants from environmental also should be pe斤。rmed. After studying various aseptic processing， two aseptic processing are selected in this article，which a space disinfection method that is propitious to a sterile filling workshop of a pharmaceutical company in Zhejiang Province and a surface disinfection method that is used for an oral solid formulation 浙江工业大学 ， 工程硕士论文 workshop. 丁he effect validation for the two aseptic methods and the residual study from the disinfector had been performed to prove the two asepti? methods can meet tbe domestic and international regulatory requirements. Meanwhile，this pharmaceutical ∞mpany has used these methods to manufacture for many years; the product quality conformed to requiremen怡 and passed many domestic and