【正文】 .................................................65 安裝圖 .......................................................................................................................................7安裝確認 ........................................................................................................................81 文件資料 ...................................................................................................................................92 主機安裝 .................................................................................................................................10 檢查并確認設備的材質(zhì)符合 GMP 要求 .................................................................10 確認機器無外觀缺陷和損壞 ....................................................................................10 確認主機已安裝穩(wěn)固 ................................................................................................10 確認設備安裝位置有充分的回轉(zhuǎn)空間和維修空間 ................................................10 確認設備與界面安裝的密封性符合要求 ................................................................11 確認設備的設計制造符合合同要求 ........................................................................11 確認設備安裝的空間符合 GMP 要求 .....................................................................11 確認設備的安裝符合國家有關壓力容器的安裝要求 ............................................113 輔助設備的安裝 .....................................................................................................................12 確認主控柜與主機連線正確 ....................................................................................12 確認壓縮空氣系統(tǒng)與主機連接正確且運行正常 ....................................................12 確認真空系統(tǒng)與主機連接正確且運行正常 ............................................................124 公用工程安裝 .........................................................................................................................13 電源確認 ....................................................................................................................13 壓縮空氣 ....................................................................................................................14 純蒸汽 ........................................................................................................................15 冷卻水 ........................................................................................................................165 儀器儀表、空氣處理系統(tǒng)的確認 .........................................................................................17 過濾器的完整性確認 ................................................................................................17 壓力表 ........................................................................................................................18 溫度探頭 ....................................................................................................................19 安全溫度計的校驗 .................................................................................................................................20運行確認 ......................................................................................................................21密封門的開關與安全溫度計的連接 .................................................................................................22緊急停機功能檢查 .............................................................................................................................23真空度及滅菌腔室內(nèi)泄露試驗 .........................................................................................................24溫度控制器及溫度記錄儀誤差試驗 .................................................................................................25空載熱分布試驗 .................................................................................................................................27ValidationFOF2 濕熱滅 菌 Page 4 of39 負載熱分布試驗 .................................................................................................................................30熱穿透試驗 ..................................................................