无菌工艺设计及风险控制杨军.pptxVIP

无菌工艺设计及风险控制杨军第1页/共57页 2无菌工艺设计及风险控制ASEPTIC ENGINEERING AND RISK CONTROL 第2页/共57页 32012 ISPE CHINA ANNUAL CONFERENCE无菌 – 没有活体微生物存在。 Aseptic – No Viable Microbe Exists无菌药品 - 法定药品标准中列有无菌检查项目的制剂和 原料药，包括无菌制剂和无菌原料药。 -- 摘自中国GMP（2010年修订） Aseptic Drug Product – The drug product which needs to be tested for their sterility by the legal standards, including aseptic formulation and APIs. -- From Chinese GMP(2010)第3页/共57页 4无菌药品的生产工艺Type of Manufacturing Process按去除微生物方法的不同：Removing of microbe from product:最终灭菌工艺 Process with final sterilization非最终灭菌工艺 Process without final sterilization第4页/共57页 5非最终灭菌工艺Process without final sterilizing 适用于产品不耐高温，不能采用通常的热力学方法最后进行灭菌以去除产品中的微生物。 For those product which are thermal-sensitive and the microbe in it can not be removed by thermal sterilization. 常用于冻干粉针、粉针、无菌原料药的生产。 Normally used in manufacturing of freeze drying powders, aseptic powdersand APIs 非最终灭菌工艺又称为无菌生产工艺。 This process is also called Aseptic Processing第5页/共57页 62012 ISPE CHINA ANNUAL CONFERENCE无菌生产工艺的特点Characteristics of Aseptic Process 在无菌生产工艺中，产品、容器、密封件等分别经过灭菌后再进行灌装、封口，而液体产品则通过无菌过滤以去除微生物。由于产品装入最终容器后不再作进一步的灭菌处理，因此整个生产过程必须保证不被微生物所污染。 All the product/container/closures are pre-sterilized All the product-liquid must be sterile filtered No further sterilization required after filling and closing Microbe contamination must be avoided during the whole processing 第6页/共57页 72012 ISPE CHINA ANNUAL CONFERENCE无菌生产工艺设计的关键 无菌生产核心区的确定 Critical Area/Core Area第7页/共57页 82012 ISPE CHINA ANNUAL CONFERENCE什么是无菌生产核心区?What is Critical/Core Area 核心区就是无菌产品、容器、包装物及其产品接触的表面直接暴露在环境条件下的区域，该区域的设计必须保证产品的无菌度要求。(FDA/ISPE) A CRITICAL AREA is one in which the sterilized drugproduct, containers/closures or product contact surfacesare exposed to environmental conditions that must bedesigned to maintain product sterility. (FDA/ISPE)第8页/共57页 9如何确定无菌生产核心区？How to define the