控制婴儿配方奶粉中阪崎肠杆菌：国际上法律法规的要求和良好的控制手段试卷.pptVIP

单击此处编辑母版标题样式 单击此处编辑母版文本样式 第二级 第三级 第四级 第五级 单击此处编辑母版标题样式 单击此处编辑母版文本样式 第二级 第三级 第四级 第五级 1 Control Enterobacter Sakazakii in Powdered Infant Formula: Regulatory Requirements and Best Practice 控制婴儿配方奶粉中阪崎肠杆菌：国际上法律法规的要求和良好的控制手段 By Joe Zhou, QA Manager of Cargill USA 周永武博士，美国嘉吉质量保证经理 Infant Formula and Microbiological Risks 婴幼儿配方奶粉和微生物风险 Enterobacter Sakazakii 阪崎杆菌 Control of Enterobacter Sakazakii 阪崎杆菌控制: 1) Zone Idea 分区 Control of Enterobacter Sakazakii 阪崎杆菌控制: 2) Mirco-biologic monitoring program 微生物监控系统 Analytical method 检测方法 Seminar Contents 内容 Mirco Risks for Powdered Infant formula 婴幼儿配方奶粉和微生物风险 The process steps associated with dried ingredients or products are the key areas that need to be controlled for micro contaminations 与干混配料和产品有关的操作步骤是需要控制微生物污染的主要区域 Salmonella and E. sak are the only two microorganisms for which a well established cause of illness in infants was identified 沙门氏菌和阪崎杆菌是仅有的两种对婴儿致病机理知晓的微生物 GMP and GHP is a key to control micro risks. GMP和GHP是控制微生物风险的主要措施 Enterobacter Sakazakii 阪崎杆菌 Enterobacter sak is an emerging pathogen for infant 阪崎杆菌是对1岁以下婴儿的致病菌 It exists everywhere 存在于所有区域 Need more strict control measures to minimize its contaminations to final products 需要更严格的控制措施减少其对最终产品的污染 The other microbiological contaminations will get controlled if E. sak could be controlled well 如果阪崎杆菌能得到很好的控制，其它微生物也相应得到良好的控制 Environmental monitoring program and zone idea are two effective ways to control E. sak 分区原则和监控程序 Environmental Monitoring Program 监控程序 Main objective of monitoring is verification that the process has been under control 监控的主要目的是确认生产过程在控制中 It could give us maximum assurance for safety of our product if this program is executed in the factory well. 如果这个程序在工厂得到很好的执行将最大程度保证我们产品的安全 Use Enterobacteriacease (EB) as an indicator organism, a family including both “S” and “Es” 环境监控应关注肠杆菌，肠杆菌是包含沙门氏菌和阪崎杆菌一个微生物“科” Zone Idea 分区原则 Need to divide the processing areas into zones to reduce unwanted contaminations 对生产区域分区以减