【正文】 FOF2 濕熱滅菌柜驗(yàn)證方案Validation ValidationFOF2 濕熱滅 菌 Page 1 of39 驗(yàn)證方案批準(zhǔn)方案起草 簽名 日期方案審核 簽名 日期方案批準(zhǔn) 簽名 日期ValidationFOF2 濕熱滅 菌 Page 2 of39 驗(yàn)證小組名單組長(zhǎng)姓名 職務(wù) /職稱 部門(mén)成員姓名 職務(wù) /職稱 部門(mén)ValidationFOF2 濕熱滅 菌 Page 3 of39 目錄引言 ..........................................................................................................................51 概述 ...........................................................................................................................................52 本公司設(shè)備編號(hào)及位置 ...........................................................................................................53 主要技術(shù)參數(shù) ...........................................................................................................................54 驗(yàn)證目的 ...................................................................................................................................65 安裝圖 .......................................................................................................................................7安裝確認(rèn) ........................................................................................................................81 文件資料 ...................................................................................................................................92 主機(jī)安裝 .................................................................................................................................10 檢查并確認(rèn)設(shè)備的材質(zhì)符合 GMP 要求 .................................................................10 確認(rèn)機(jī)器無(wú)外觀缺陷和損壞 ....................................................................................10 確認(rèn)主機(jī)已安裝穩(wěn)固 ................................................................................................10 確認(rèn)設(shè)備安裝位置有充分的回轉(zhuǎn)空間和維修空間 ................................................10 確認(rèn)設(shè)備與界面安裝的密封性符合要求 ................................................................11 確認(rèn)設(shè)備的設(shè)計(jì)制造符合合同要求 ........................................................................11 確認(rèn)設(shè)備安裝的空間符合 GMP 要求 .....................................................................11 確認(rèn)設(shè)備的安裝符合國(guó)家有關(guān)壓力容器的安裝要求 ............................................113 輔助設(shè)備的安裝 .....................................................................................................................12 確認(rèn)主控柜與主機(jī)連線正確 ....................................................................................12 確認(rèn)壓縮空氣系統(tǒng)與主機(jī)連接正確且運(yùn)行正常 ....................................................12 確認(rèn)真空系統(tǒng)與主機(jī)連接正確且運(yùn)行正常 ............................................................124 公用工程安裝 .........................................................................................................................13 電源確認(rèn) ....................................................................................................................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(rèn) .........................................................................................17 過(guò)濾器的完整性確認(rèn) ................................................................................................17 壓力表 ........................................................................................................................18 溫度探頭 ....................................................................................................................19 安全溫度計(jì)的校驗(yàn) ....................................................................................................