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gzlyz20凍干機再驗證方案(完整版)

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【正文】 bers and the selfdiscipline norms, moral declaration issued to all members of the party and the National People39。s eighteen years prehensive strictly practice. (a) revised two regulations of the party need of the ICAC guidelines in in 1997 Leaders as members of the Communist Party of China clean politics certain criteria (Trial) based on revised, the promulgation and implementation of January 2010, to strengthen the construction of the contingent of leading cadres play an important role. But with the party to manage the party strictly administering the deepening, has not been able to fully meet the actual needs. Content is too plicated, eight prohibition, 52 are not allowed to hard to remember, and also difficult to put into practice。七. 驗證結(jié)論及評價 由驗證小組依據(jù)驗證報告進行逐項的驗證確認后,根據(jù)檢測情況和數(shù)據(jù)統(tǒng)計進行的分析判斷,并做出相應(yīng)的評價 由驗證領(lǐng)導(dǎo)小組根據(jù)驗證小組的報告發(fā)表審核意見,并簽署報告批準書(英文版 ) Two regulations promulgated for implementation is in the party in power for a long time and the rule of law conditions, the implementation of prehensive strictly strategic plan, implementation in accordance with the rules and discipline to manage the party, strengthen innerparty supervision of major initiatives. The two regulations supporting each other, the code adhere to a positive advocate, focusing on morality is of Party members and Party leading cadres can see, enough to get a high standard。 數(shù)據(jù)記錄: 見附錄八結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:檢測凍干機的安全性能是否符合設(shè)計要求合格標準:達到以下性能要求 斷水保護:水壓力,凡用水冷卻的設(shè)備不能工作?!^續(xù)抽真空2小時,記錄極限真空度。數(shù)據(jù)記錄: 見附錄三結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:檢查并確認冷凝器的降溫速率符合設(shè)計要求。——啟動凍干機器,在空載狀態(tài)下進行溫度分布測試,溫度測試點分別為30℃、0℃、30℃記錄試驗數(shù)據(jù)。(是否符合材料配置要求)(檢測其是否符合施工圖紙要求)結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:設(shè)備的保濕系統(tǒng)安裝符合設(shè)計要求 項目 要求 實測結(jié)論保溫材料阿姆斯壯隔熱材料所需保溫的管路、設(shè)備板式交換器、氣分、制冷管路保溫質(zhì)量保溫材料包扎牢固,各接頭處均經(jīng)密封,外潔凈、美觀,無大面積結(jié)霜結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:確認冷凝器和凍干箱度面的傾斜度符合設(shè)計要求 合格標準:當(dāng)冷凝器和凍干箱有水時,打開放水閥,其中的水大部分能放出 驗證程序:打開進水閥,當(dāng)箱內(nèi)有積水時,打開放水閥,約十分鐘后,觀察箱內(nèi)積水情況 檢查結(jié)果:結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 序號儀器儀表名稱規(guī)格生產(chǎn)廠家/國家數(shù)量12345678910所有儀器儀表由廠家負責(zé)校驗工作,廠家提供檢驗標準合格證(注明校驗日期、有效期、計量部門蓋章) 校驗結(jié)果序號儀器儀表名稱規(guī)格生產(chǎn)廠家數(shù)量校正結(jié)果合格證12345678910儀器儀表校準結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 驗證目的: 檢查并確認凍干機空載運行時板層溫度均勻性符合設(shè)計要求,溫控能力符合設(shè)計要求。用500V兆歐表測電機接線導(dǎo)線和保護接地電路間的絕緣電阻。含水量是否達到標準,可以從溫度曲線上確定。 制品放入干燥箱內(nèi),制冷系統(tǒng)對板層進行制冷,板層向制品吸收熱量,從而對制品進行凍結(jié),即制品從液態(tài)轉(zhuǎn)化為固態(tài)。用戶可實現(xiàn)屏幕操作。優(yōu)質(zhì)的AISI316L不銹鋼板層薄形空心夾板形式。再驗證方案GZLYZ20冷凍干燥機再驗證方案目錄一. 概述…………………………………………………………6二. 安裝確認……………………………………………………9三. 儀器儀表校正………………………………………………16四. 運行確認……………………………………………………18五. 性能確認……………………………………………………27六. 再驗證周期…………………………………………………27七. 驗證結(jié)論及評價……………………………………………27八. 驗證報告批準書……………………………………………27 GZLYZ20(CIP、SIP)真空冷凍干燥機是由上海遠東制藥機械總廠生產(chǎn),適用于醫(yī)藥的凍干粉針的專用設(shè)備,設(shè)備各項技術(shù)指標均處于國內(nèi)先進水平。平整度為177。——液壓系統(tǒng):采用高質(zhì)量閥件制成的液壓泵和油缸組成液壓系統(tǒng),徹底消除液壓油的泄漏問題。此階段要求凍結(jié)至制品共晶點(溶液全部凝結(jié)的溫度)以下,并保持一段時間(一般為2小時左右),以確保使制品全部凍結(jié)。、設(shè)計、制造符合GMP要求;;,公用工程系統(tǒng)配套齊全且符合設(shè)計要求;、儀表經(jīng)過校正且合格;;;、改造和再驗證提供數(shù)據(jù)資料。檢查結(jié)果:絕緣電阻值:結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 序號檢測項目檢測依據(jù)實測結(jié)論 1PLC控制單元 三菱FN2根據(jù)供應(yīng)商提供的質(zhì)量證明、使用說明檢測其性能。合格標準:——板層各點之間溫差小于177。 測溫電阻點布置圖:A1B1C1A2B2C2A3B3C3 數(shù)據(jù)記錄: 見附錄一結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: (冷媒)的降溫速率 目的:檢查并確認板層(冷媒)的降溫速率符合設(shè)計要求。合格標準:從室溫(20℃)降至40℃的時間不大于30min。數(shù)據(jù)記錄: 見附錄五結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:檢查并確認箱體的密封性符合設(shè)計要求。 斷氣保護:空氣壓力 MPa將報警,同時自動程序不被執(zhí)行。 rule around the party discipline, disciplinary ruler requirements, listed as negative list, focusing on vertical gauge, draw the party organizations and Party members do not touch the bottom line . Here, the main from four square face two party rules of interpretation: the first part introduces two party Revised regulations the necessity and the revision process。 the second is concisely positive advocated by the lack of prohibited provisions excessive, no autonomy requirements。s solemn mitment. criterion of a clean and honest administration consists of 4 parts, 18, more than 3600 words. After the revision of the code , a total of eight, 281 words, including lead, specification and Party member cadre clean fingered selfdiscipline norms, etc. Part 3 members lowcost clean and selfdiscipline, the main contents can be summarized as four must eight code. Lead part, reiterated on ideal and faith, fundamental purpose, the fine traditions and work style, noble sentiments, such as four must the principle of requirements, strong tone of selfdiscipline, The higher request for 6 and supervised tenet, the foothold in permanent Bao the party39。 at the same time, to investigate violations of Party members and even criminal behavior of Party discipline and responsibility, Regulations distinguish five different conditions, with special pr
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