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大连昆阳制药有限公司STP/YZ105-00第１页共6页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。大连昆阳制药有限公司STP/YZ105-00第２页共6页目录验证方案·····································································································································31概述···································································································································32目的···································································································································33职责···································································································································34内容···································································································································34.1预确认·······················································································································34.2安装确认·······························································································34.3运行确认···················································································································34.4性能确认···················································································································34.4.1目的·······················································································································44.4.2可接受标大连昆阳制药有限公司STP/YZ105-00第３页共6页准···········································································································44.4.3静态尘埃粒子检测·······························································································44.4.4静态沉降菌检测···································································································45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大连昆阳制药有限公司STP/YZ105-00第４页共6页验证方案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性能确认大连昆阳制药有限公司STP/YZ105-00第５页共6页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。4.4.3.2.3取净化工作台左、中、右三个点进行检测，每个点打印数据三次（见附件5）。4.4.4静态沉降菌检测4.4.4.1目的考察设备运行时能否达到百级环境沉降菌数≤1/皿的要求4.4.4.2测试与方法：4.4.4.2.1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。4.4.4.2.2将已预孵合格的φ90mm琼脂平皿五个分别放置在净化工作台上两个、中一个、下两个，打开平皿盖子，暴露30分钟后盖上盖子，将平皿放入35～37℃恒温培养箱中培养48小时，记录菌落数（见附件6）。5日常监控（1）在日常运行中要经常检查设备的运行状况。（2）日常监控：QC人员每个月监测。（3）正常情况下系统每年做一次验证。大连昆阳制药有限公司STP/YZ105-00第６页共6页附件1：确认内容及可接受标准附件2：资料档案确认表附件3：安装确认记录表确认内容接受标准确认结果确认人主机外观无损伤，表面喷涂处理或为不锈钢材料安装位置SW-CJ-2FD无菌检查室环境要求万级洁净室内，地面应平整结论：实施人：日期：审核人：日期：确认内容可接受标准确认结果确认人电源电压220V50Hz尘埃粒子数（0.5μm）≤3500个/m3尘埃粒子数（5μm）≤0个/m3沉降菌数≤1平均风速0.35M/S±20%结论：实施人：日期：审核人：日期：确认内容存放处确认结果确认人使用说明书产品合格证结论：实施人：日期：审核人：日期：大连昆阳制药有限公司STP/YZ105-00第７页共6页附件4：运行确认记录表（无菌检查室）附件5：静态尘埃粒子确认记录表（无菌检查室）附件6：静态沉降菌确认记录表（无菌检查室）确认内容接受标准确认结果确认人标准操作规程适用性适用仪器运转情况正常结论：实施人：日期：审核人：日期：确认内容可接受标准确认结果确认人左侧≤3500个/m3(0.5μm)≤0个/m3(5μm)中部≤3500个/m3(0.5μm)≤0个/m3(5μm)右侧≤3500个/m3(0.5μm)≤0个/m3(5μm)结论：实施人：日期：审核人：日期：确认内容可接受标准确认结果确认人1≤2≤3≤45结论：实施人：日期：审核人：日期：