STPYZ106-00101-2A型数显电热鼓风干燥箱验证方案.doc

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1、101-2A型数显电热鼓风干燥箱验证方案起草人：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·················································································

2、·······································································31概述···································································································································32目的·························································································

3、··········································33职责···································································································································34验证内容····················································································································

4、·······34.1设备确认···················································································································34.1.1文件资料确认···································································································34.1.2设备安装确认··············································

5、·····················································34.2负载形式···················································································································34.2.1空柜验证···········································································································34.2.2

6、负载验证···········································································································4附件1：文件资料确认记录附件2：设备安装确认记录附件3：负载验证试验记录附件4：装载内容物及数量记录附件5：灭菌去热源检查记录验证方案1概论(1)设备名称：101-2A型数显电热鼓风干燥箱(2)制造厂家：上海阳光实验仪器有限公司。(3)特点与用途：电热鼓风干燥箱主要由工作室、鼓风装置、电热器、自动控温系统组成。工作室尺寸具有大小四种规格，可供各种试品置入使用，适用于干燥、

7、热处理及其他加热，配套的鼓风装置，可促成箱内热空气机械对流，温度均匀，试品至于其内进行各种处理，可获得一致的结果。其工作温度可由室温升10℃起至最高温度止（最高工作温度为300℃），在此范围内可任意选定工作温度，选取定后可借箱内自动控制系统使温度恒温。2目的通过对101-2A型数显电热鼓风干燥箱，确认该设备能满足生产中灭菌、除热原的需要。3职责质量部QC室：负责起草101-2A型数显电热鼓风干燥箱的验证方案、