制药企业培训-无菌生产.pptxVIP

Aseptic Processing Overview 无菌工艺概述 Purpose 目标 To provide an overview of Aseptic Operations for personnel working in Aseptic areas. 为无菌区域内工作的操作人员提供无菌操作的概述 Audience 受众 Aseptic Operators 无菌操作员工 Course Length课时 2.0 hours Required 要求的Document(s)文件 N/A Equipment / 设备Materials / 材料Resources 资源 N/A Safety Precautions / PPE安全措施/个人防护装备 N/A Prerequisite 前期Training培训 N/A Press F5 now to view this presentation as a Slide Show At the end of the course, you will be able to:课程结束时，你将有下列能力： List examples of general aseptic rules列举无菌操作的一般规则 Know the position you should be in when not performing a task当不做任务时，知道自己的职责 Define interventions明确干涉 Describe Airflow Pattern Testing (AFPT)描述气流模式测试 Describe the EM testing performed on gowned aseptic operators 描述EM测试时的无菌更衣操作 Course Objectives课程目标 Confirm your ResponseCard is communicating with the receiver. 确定你的问答仪正在和接收者交流 The ResponseCard should be set to channel 41. 问答仪要调到41频道 Press the Channel button (may also use CH or GO).按频道按钮（也可能使用CH或者GO） Enter the 2-digit channel number (41). 确认41频道 Press the Channel button again. 再次按下频道按钮 When the ResponseCard receives the new channel, the light will turn green. 当问答仪收到新的频道信号时，指示灯就会变成绿色。 Using your ResponseCard Lesson 1: General Aseptic Practices基本的无菌规范 In this section, we will review:在这部分,我们将看到: GMP regulations that affect aseptic operations 影响无菌操作的GMP法规 What aseptic operators should do if they are ill 当无菌操作者生病了应该做什么 General principles for working in the aseptic area 在无菌工作区的基本准则 The importance of moving slowly in the aseptic environment在无菌环境缓慢移动的重要性 cGMPs Good Manufacturing Practices (GMPs) are regulations issued by the Food and Drug Administration GMP是由食物和药品管理局（FDA)发布的 The “c” stands for “current.” Over time, the GMPs become stricter, requiring higher and higher levels of performance c代表当前，GMP变得越来越严格，要求越来越高的实施水平 GMPs are published in the Code of Federal Regulations GMP由美国联邦法规出版 The objective is to protect consumers from drugs (or food) that a