型净化工作台验证方案

1、SW-CJ-2FD净化工作台验证方案起 草 人：审 核 人：批 准 人：起草部门：起草日期：审核日期：批准日期：执行日期：验证小组会签部门岗位签名签名日期颁发部门： 质量部Copy ： 行政部 物供部 质量部QA 质量部QC 研发部 生技部 疫苗车间 分包装车间 工程部 保安部 营销部 财务部 变更记载：修订号 批准日期 执行日期00变更原因及目的：建立验证文件，并通过验证证明所验证对象有效、稳定、可靠。目 录验证方案···············

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35、标准附件2：资料档案确认表附件3：安装确认记录表附件4：运行确认记录表附件5：静态尘埃粒子确认记录表附件6：静态沉降菌确认记录表验证方案1 概述净化工作台主要用于为试验提供百级试验环境，减少试验过程中微生物污染的机率，为试验检测数据的准确性提供重要的保障。因此必须对净化工作台进行验证，以确保该设备能提供一个长期稳定的洁净环境，确保检验数据的真实可靠。本方案规定了净化工作台的验证方案及接受标准，依据是净化工作台的使用说明书和SW-CJ-2FD型净化工作台使用、维护保养标准操作规程2 目的对该设备进行验证，以确保该设备能提供稳定的洁净环境，确保检验数据的真实可靠。3 职责质量部QC室：负责起草质量部QC室净化工作台的验证方案，报告及验证实施。工程部：协助质量部进行净化工作台的验证实施。验证小组：负责验证方案的实施、验证方案与验证报告的审核会签。验证管理员：负责对验证过程进行协调检查。QC检验员：负责验证中的取样检验，测试检验数据，并出具准确的检验报告。4 验证内容4.1 预确认：见附件14.2 安装确认4.2.1 资料档案：确认内容见附件2。4.2.2 安装确认：确认内容见附件3。4.2.3 仪表检验 尘埃粒子计数器由生产厂家进行校验。4.3 运行确认4.3.1 目的4.3.1.1 对标准操作规程的适用性进行确认。4.3.1.2 检查确认系统运转是否正常，并符合技术参数要求。对操作