STPYZ10500SWCJ2FD型净化工作台验证方案_超净化工作台验证方案

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大连昆阳制药有限公司STP/YZ105-00

SW-CJ-2FD净化工作台验证方案

验证方案·····································································································································3 1 概述···································································································································3 2 目的···································································································································3 3 职责···································································································································3 4 内容···································································································································3 4.1 预确认·······················································································································3 4.2 安装确认·······························································································3 4.3 运行确认···················································································································3 4.4 性能确认···················································································································3 4.4.1 目的·······················································································································4 4.4.2 可接受标准···········································································································4 4.4.3 静态尘埃粒子检测·······························································································4 4.4.4 静态沉降菌检测···································································································4 5 日常监控···························································································································4 附件1：确认内容及可接受标准附件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》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。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1 4.2 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。对操作规程的适用性进行确认。

4.3.1.3 测试记录见附件4。4.4 性能确认

4.4.1 目的4.4.1.1 检查确认系统运转是否正常，并符合技术参数要求，满足工作需要。4.4.1.2 对操作规程的适用性进行确认。

4.4.2 可接受标准：操作各控制器时，应灵活有效，洁净度应符合技术参数要求。4.4.3 静态尘埃粒子检测 4.4.3.1 目的考察设备运行时能否达到百级环境内尘埃粒子数的要求 4.4.3.2 测试与方法：

4.4.3.2.1 按《SW-CJ-2F型净化工作台使用、维护保养标准操作规程》进行操作，开启净化工作台通风30分钟。

4.4.3.2.2 按《CLJ-BM型尘埃粒子计数器使用、维护保养标准操作规程》进行操作，将仪器自净20分钟后进行检测。