制药企业培训--人员基础微生物学

FDA Response FDA的应对措施
The worst effects are those on the patient. 最坏的影响是对于患者
Effects range from fever to death. 影响的范围从发烧到死亡
Consequences to the Patient 对患者的 影响
Infants, the elderly, and those with compromised health are susceptible because it takes a smaller amount of contaminant to cause illness or death for them.婴儿，老年人以及缺乏抵抗力的人易受到影响，因为这些人少量的污 染物就会导致疾病或者死亡。 To prevent a possible tragedy, we must strictly adhere to defined cleaning, sanitization, aseptic technique, and gowning requirements. 为了预防可能的悲 剧，我们必须严格的坚持明确清洁，消毒，无菌技术，和更衣的要求。
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Prerequisite Training前期培训
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Course Objectives 课程目标
At the end of the course, you will be able to identify / define: 本课程结束后，你将能够鉴别/明确： • The types of contamination 污染的类型 • Where contamination comes from 污染的来源 • The consequences of contaminated product 产品污染的影响 • Aseptic processing 无菌过程 • The basic processes used to protect medicine 药物保护的基本流程 • Different types of organisms 不同类型的微生物
What is Contamination?什么是污染
Contamination: A state of impurity caused by the presence of unwanted living (viable) or particulate (nosequences影响
In this course, we are concerned about mitigating hazard ingress (e.g., minimizing contamination entry) due to our work in the aseptic area. However, wherever the contaminant comes from, it has consequences:在这 部分内容，我们会关注怎样通过我们在无菌区域内的工作来减轻危害进 入（例如，使污染最小化），但是无论污染物来源于哪里，都会有影响。 If discovered during Production: It causes product loss and / or delays.如果在 生产过程中发现：会导致产品的缺损和/或延误 If discovered after market: it results in actions such as: 如果在售后市场发现：会导致以下后果 FDA intervention FDA调查 Medical crisis for the patient 对患者的药物危机 Impact to Lilly brand 影响lilly的商标
Contaminated Product that made it to the Market 污染的产品进 入市场
Texas, 1989, contaminated iodine leads to infection (peritonitis). 6 people infected. Clinipad Corporation voluntary recalls the lot. 德克萨斯洲,1989年，受污染的碘导致感染（腹膜炎）。 6个人受到感染，Clinipad公司召回了那个批次。 Utah hospital, October to November 1994, contaminated balanced salt solution leads to 3 children getting meningitis. Life Technologies, Inc. issued a voluntary recall of the lot. Utah 医院，1994年 10月至11月，受污染的平衡盐溶液导致3个儿童感染脑膜炎。生命技术股份公司发布自愿召回 那个批次。 Brazil, October 1996, contamination of unopened vials of bidistilled water and glucose leading to sepsis (bacteria in the blood). 35 newborns die; 20 deaths attributed to sepsis. Hipolabor Farmaceutica Ltd was closed. 巴西，1996年10月，污染的未开封的重蒸馏水和葡萄糖药水瓶导 致了败血症（细菌进入到血液。35个新生儿死亡；20个是因为败血症导致的死亡。Hipolabor Farmaceutica公司也因此关门了 New England, 2012, contaminated steroid product leads to fungal meningitis. By March 2013, 48 people died and at least 720 infected. FDA recalls all New England Compounding Center (NECC) lots. By December 2012, NECC filed for bankruptcy.新英格兰，2012年，受污染的类固醇产品导致了真 菌性脑膜炎，到2013年三月，48人死亡，至少720人感染。FDA召回了NECC的所有批次，到 2012年12月NECC申请破产
Types of Contaminants污染的类型
Contaminants we work to eliminate include:需要清除的污染物 包括：
Microorganisms (viruses, spores, bacteria) 微生物（病毒，芽孢，细菌） Endotoxins (fragments of organisms)细菌内毒素（微生物体碎片） Particulates (non-living contaminants)微粒（非生命的污染物） Cross-contamination (e.g., other product, cleaning agents)交叉污染（例如，其他 产品，清洁剂）
Lesson 1: Contamination 课程1：污染
In this section, we will review:在本节中，我们会回顾： The definition of contamination污染的定义 The types of contamination污染的类型 The consequences of contaminated product 产品污染的 影响 Where contamination comes from污染的来源
Why Avoiding Contamination is Particularly Important in Parenteral为 什么避免污染对注射用药物特别重要
Parenteral medicines are not taken orally, but by injection such as subcutaneous (under the skin), intramuscular (into muscles), intravenous (into blood vessels).注射类药 物不是口服的，而是通过注射，例如皮 下注射（皮肤下），肌肉注射（到肌肉 里），静脉注射（到血管里） Injectable products bypass some of the natural defenses of the body (e.g., the mucus membrane, the skin) and enters the blood stream quickly.注射类产品会避开人体的 自身防御功能。
Basic Microbiology Overview 基础微生 物学概述
Purpose 目的 Audience 听众 Course Length 课 时 Required Document(s) 相关文件 Equipment / 设备 Materials / 材料 Resources资源 Safety Precautions / PPE安全措施/个人 防护 To provide an overview of contamination and basic microbiology for personnel working in aseptic areas. 向无菌区域的工作人员简要介绍关于污染和基本微生物学 Aseptic Operators 无菌操作人员 2 hours
污染：是一种有害的生物（有生命的）或者微粒（无生命的）物质存在于产品 中而导致的产品不纯的状态。
The #1 reason to avoid contamination is patient safety.
避免污染是患者安全的首要因素。