stpyz00700真空系统验证方案

1、真空系统验证方案起 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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30、183;····················5附件1：真空系统工艺流程图附件2：文件资料的确认记录附件3：主要设备安装确认记录附件4：管路分配系统的安装确认记录附件5：管道试压记录附件6：公用工程安装确认记录附件7：仪器仪表的校正确认记录附件8：运行确认记录验证方案1 概述（1）待验证的真空系统位于工程部空调机房。整个系统由液环真空泵、贮气罐、气水分离器及管道系统组成。该系统在疫苗制备过程中用

31、于液体的转移，分装过程中为吸起胶塞提供真空等。系统工艺流程图见附件1。（2）主要技术参数：系统真空度：-0.08mpa 吸气压力不得低于80mbar最大排气压力为1100mbar最大气喷射器可获得10mbar最大压差：200mbar工作液流量：0.5m3/h允许从吸气法兰吸入的最大水量：0.7m3/h2 目的通过对真空系统的验证，证明该系统在实际生产中能够提供稳定的真空。具体包括：（1）确认系统设备所用材质、安装均符合设计要求和gmp要求；（2）确认管路分配系统所用材质、安装均符合设计要求和gmp要求；（3）确认系统所有文件资料齐全，符合gmp要求；（4）确认设备配套公用工程符合设计要求和gm

32、p要求；（5）确认系统设备的各种仪器仪表经过校正合格；（6）确认系统各种控制功能符合设计要求；（7）确认系统设备在操作范围内能稳定运行，产生的真空度能达到设计标准；（8）确认真空系统设备工艺管道流程图；（9）确认真空系统设备平面布局图。3 职责工程部：参与设备验证方案的确定，负责设备的接收、检查与安装，负责设备档案资料的整理，负责验证方案和报告的起草，负责验证的实施。物供部：参与设备采购方案的确定，负责设备的采购、并要求厂家提供验证所需技术资料。生技部：负责设备采购方案的确定，参与验证方案的审核，辅助验证的实施。质量部：参与设备采购方案的确定，负责验证方案的审核，参与和监督验证的实施，负责验证

33、报告的审核，验证小组总负责人负责验证方案和报告的批准。4 验证内容与记录4.1 安装确认4.1.1 文件资料的确认方法：采购设备前明确要求厂家提供完整的技术资料，设备到后对所附资料进行清理，缺少的资料及时向厂家索取，整理分类后存入设备档案。标准：所有资料应能满足真空系统正常运行要求和gmp的要求。记录：见附件24.1.2 主要设备安装确认方法：对照设计方案和厂家提供的相关技术资料，检查系统设备单体的材质及安装情况。标准：设备的材质和安装情况均符合设计要求。记录：见附件34.1.3 管路分配系统的安装确认方法：（1）检查管路分配系统管道和阀门的材质是否为304不锈钢；（2）检查管路分配系统管道是

34、否采用热熔式氩弧焊焊接，内壁是否光滑；（3）检查管路分配系统管道焊接结束后，是否进行管道试压试验。（见附件5）标准：所有管道材质及必要的处理均符合设计要求。记录：见附件44.1.4 管道压力测试确认管道、设备安装完成后，必须做压力试验和密封性试验进行检查。压力试验又称之为强度试验。 方法：压力试验时，用空压机压入无油空气（或惰性气体），缓慢增加压力至设计压力的1.15倍，然后用发泡剂检查所有接口，不泄漏为合格。 标准：根据设计要求，密封性试验按如下进行。压入无油空气（或惰性气体） 至系统操作压力，稳压30分钟，记下管道中的压力p1和温度t1,12小时后记下此时的p2和t2。分别换算成绝对压力p1、p2和绝对