【正文】 干熱滅菌柜驗證方案Validation 編號:VP驗證方案批準(zhǔn)方案起草 簽名 日期方案審核 簽名 日期方案批準(zhǔn) 簽名 日期驗證小組名單組長姓名 職務(wù) /職稱 部門成員姓名 職務(wù) /職稱 部門目錄引言 ............................................................................................................................................................51 概述 ...........................................................................................................................................52 本公司設(shè)備編號及位置 ...........................................................................................................53 主要技術(shù)參數(shù) ...........................................................................................................................54 驗證目的 ...................................................................................................................................55 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 檢查并確認(rèn)機(jī)器無外觀缺陷和損壞 ........................................................................10 確認(rèn)主機(jī)已安裝穩(wěn)固 ................................................................................................10 確認(rèn)主機(jī)與控制柜、計算機(jī)系統(tǒng)連接正確 ............................................................11 確認(rèn)設(shè)備安裝位置有充分的回轉(zhuǎn)空間和維修空間 ................................................11 檢查設(shè)備安裝與天花板界面密封良好 ....................................................................11 檢查可拆卸的工作部件應(yīng)易于拆卸、安裝 ............................................................12 確認(rèn)設(shè)備的外觀及內(nèi)腔尺寸符合合同要求 ............................................................12 確認(rèn)設(shè)備的送風(fēng)系統(tǒng)及排風(fēng)系統(tǒng)符合設(shè)計要求 ....................................................123 輔助設(shè)備安裝 .........................................................................................................................13 檢查并確認(rèn)主電源電壓為 380VAC..........................................................................13 檢查并確認(rèn) PLC 電源電壓為 24VPC......................................................................13 冷卻水 ........................................................................................................................13３ .4 壓縮空氣 ................................................................................................................144. 儀器儀表空氣處理系統(tǒng)的確認(rèn) .............................................................................................15 壓力表 ........................................................................................................................15 溫度探頭 ....................................................................................................................16 高效過濾器 ....................................................