1、真空系統驗證方案起 草 人：審 核 人：批 準 人：起草部門：起草日期：審核日期：批準日期：執行日期：驗證小組會簽部門崗位簽名簽名日期頒發部門： 質量部copy ： 行政部 物供部 質量部qa 質量部qc 研發部 生技部 疫苗車間 分包裝車間 工程部 保安部 營銷部 財務部 變更記載：修訂號 批準日期 執行日期00變更原因及目的：建立驗證文件，并通過驗證證明所驗證對象有效、穩定、可靠。目 錄驗證方案················

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30、183;····················5附件1：真空系統工藝流程圖附件2：文件資料的確認記錄附件3：主要設備安裝確認記錄附件4：管路分配系統的安裝確認記錄附件5：管道試壓記錄附件6：公用工程安裝確認記錄附件7：儀器儀表的校正確認記錄附件8：運行確認記錄驗證方案1 概述（1）待驗證的真空系統位于工程部空調機房。整個系統由液環真空泵、貯氣罐、氣水分離器及管道系統組成。該系統在疫苗制備過程中用

31、于液體的轉移，分裝過程中為吸起膠塞提供真空等。系統工藝流程圖見附件1。（2）主要技術參數：系統真空度：-0.08mpa 吸氣壓力不得低于80mbar最大排氣壓力為1100mbar最大氣噴射器可獲得10mbar最大壓差：200mbar工作液流量：0.5m3/h允許從吸氣法蘭吸入的最大水量：0.7m3/h2 目的通過對真空系統的驗證，證明該系統在實際生產中能夠提供穩定的真空。具體包括：（1）確認系統設備所用材質、安裝均符合設計要求和gmp要求；（2）確認管路分配系統所用材質、安裝均符合設計要求和gmp要求；（3）確認系統所有文件資料齊全，符合gmp要求；（4）確認設備配套公用工程符合設計要求和gm

32、p要求；（5）確認系統設備的各種儀器儀表經過校正合格；（6）確認系統各種控制功能符合設計要求；（7）確認系統設備在操作范圍內能穩定運行，產生的真空度能達到設計標準；（8）確認真空系統設備工藝管道流程圖；（9）確認真空系統設備平面布局圖。3 職責工程部：參與設備驗證方案的確定，負責設備的接收、檢查與安裝，負責設備檔案資料的整理，負責驗證方案和報告的起草，負責驗證的實施。物供部：參與設備采購方案的確定，負責設備的采購、并要求廠家提供驗證所需技術資料。生技部：負責設備采購方案的確定，參與驗證方案的審核，輔助驗證的實施。質量部：參與設備采購方案的確定，負責驗證方案的審核，參與和監督驗證的實施，負責驗證

33、報告的審核，驗證小組總負責人負責驗證方案和報告的批準。4 驗證內容與記錄4.1 安裝確認4.1.1 文件資料的確認方法：采購設備前明確要求廠家提供完整的技術資料，設備到后對所附資料進行清理，缺少的資料及時向廠家索取，整理分類后存入設備檔案。標準：所有資料應能滿足真空系統正常運行要求和gmp的要求。記錄：見附件24.1.2 主要設備安裝確認方法：對照設計方案和廠家提供的相關技術資料，檢查系統設備單體的材質及安裝情況。標準：設備的材質和安裝情況均符合設計要求。記錄：見附件34.1.3 管路分配系統的安裝確認方法：（1）檢查管路分配系統管道和閥門的材質是否為304不銹鋼；（2）檢查管路分配系統管道是

34、否采用熱熔式氬弧焊焊接，內壁是否光滑；（3）檢查管路分配系統管道焊接結束后，是否進行管道試壓試驗。（見附件5）標準：所有管道材質及必要的處理均符合設計要求。記錄：見附件44.1.4 管道壓力測試確認管道、設備安裝完成后，必須做壓力試驗和密封性試驗進行檢查。壓力試驗又稱之為強度試驗。 方法：壓力試驗時，用空壓機壓入無油空氣（或惰性氣體），緩慢增加壓力至設計壓力的1.15倍，然后用發泡劑檢查所有接口，不泄漏為合格。 標準：根據設計要求，密封性試驗按如下進行。壓入無油空氣（或惰性氣體） 至系統操作壓力，穩壓30分鐘，記下管道中的壓力p1和溫度t1,12小時后記下此時的p2和t2。分別換算成絕對壓力p1、p2和絕對