【正文】 是否符合設(shè)計(jì)要求合格標(biāo)準(zhǔn)：凍干箱加熱至干燥狀態(tài)，冷凝器溫度小于50℃時(shí)，真空度自一個(gè)大氣壓升高到10Pa時(shí)，所需要的時(shí)間小于30min。 驗(yàn)證程序：——冷凝器制冷到50℃；——凍干箱加熱至35℃；——開啟真空泵/真空泵組，記錄開啟時(shí)間?！^續(xù)抽真空2小時(shí)，記錄極限真空度。合格標(biāo)準(zhǔn)：真空泄漏率為≤?m3/s 驗(yàn)證程序：——按照凍干機(jī)使用標(biāo)準(zhǔn)操作規(guī)程在空載狀態(tài)下運(yùn)行凍干機(jī)；——冷凝器制冷到50℃；——凍干箱加熱至35℃；——開啟真空泵； ——當(dāng)達(dá)到極限真空度時(shí)，關(guān)閉真空大蝶閥保壓；——到達(dá)5Pa時(shí)開始計(jì)時(shí)，觀察真空度變化。數(shù)據(jù)記錄： 見附錄七結(jié)論：執(zhí)行人： 日期： 復(fù)核人： 日期： 目的：確認(rèn)凍干機(jī)的捕水能力達(dá)到設(shè)計(jì)要求。連續(xù)干燥24小時(shí)，停機(jī)稱量平底托盤中的殘留注射用水的量，按照下列公式計(jì)算凍干機(jī)的最大捕水量。 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(cè)凍干機(jī)的安全性能是否符合設(shè)計(jì)要求合格標(biāo)準(zhǔn)：達(dá)到以下性能要求 斷水保護(hù)：水壓力,凡用水冷卻的設(shè)備不能工作。 真空保護(hù)：真空度設(shè)定為10~30Pa（可自己設(shè)定）,當(dāng)真空度超出此范圍時(shí)將報(bào)警。驗(yàn)證程序：按以上要求進(jìn)行測(cè)試測(cè)試結(jié)果：結(jié)論：執(zhí)行人： 日期： 復(fù)核人： 日期： 目的：檢測(cè)大蝶閥的氣密性。檢測(cè)項(xiàng)目及結(jié)果：按鈕狀態(tài)實(shí)驗(yàn)次數(shù)結(jié)論備注開關(guān)壓縮機(jī)1壓縮機(jī)2板冷閥1板冷閥2摻冷閥冷凝器閥1冷凝器閥2循環(huán)泵1循環(huán)泵2真空泵1真空泵2水環(huán)泵大蝶閥小蝶閥摻氣閥前箱進(jìn)氣閥后箱進(jìn)氣閥液壓泵板層上升板層下降溢流閥前箱進(jìn)水閥后箱進(jìn)水閥前箱出水閥后箱出水閥電加熱有限量泄漏(啟動(dòng))真空?qǐng)?bào)警消警操作記錄冷凍干燥在位清洗在位消毒趨勢(shì)曲線工藝報(bào)表報(bào)警項(xiàng)目有效性結(jié)論備注有效無效水壓力空氣壓力真空?qǐng)?bào)警高壓報(bào)警1高壓報(bào)警2油壓差1油壓差2熱保護(hù)1熱保護(hù)2收液1收液2超溫報(bào)警`結(jié)論：執(zhí)行人： 日期： 復(fù)核人： 日期： 壓縮機(jī)組測(cè)試 目的：確認(rèn)壓縮機(jī)組的各項(xiàng)性能符合設(shè)計(jì)要求 合格標(biāo)準(zhǔn)及驗(yàn)證程序：依下列所示進(jìn)行開機(jī)運(yùn)行，觀察各相關(guān)參數(shù)的具體數(shù)值，并進(jìn)行判斷檢測(cè)或檢查項(xiàng)目合格標(biāo)準(zhǔn)實(shí)測(cè)結(jié)果結(jié)論水循環(huán)系統(tǒng)冷卻水泵，冷凍水泵，冷卻塔風(fēng)機(jī)運(yùn)轉(zhuǎn)正常，水管及接口處不滲漏機(jī)組氣密性增壓試驗(yàn)充氮?dú)庵林评涔苈分?，真空試?yàn)關(guān)閉制冷機(jī)通大氣閥門，開啟真空泵，停真空泵24H后，真空度下降不小于25 pa安全聯(lián)鎖系統(tǒng)冷卻水和冷凍水的壓力低于規(guī)定值時(shí)能進(jìn)行報(bào)警并停止工作數(shù)據(jù)記錄：檢測(cè)方法檢測(cè)數(shù)據(jù)結(jié)論時(shí)間壓力讀數(shù)漏點(diǎn)增壓試驗(yàn)真空試驗(yàn)檢查結(jié)果：結(jié)論：執(zhí)行人： 日期： 復(fù)核人： 日期： （模擬試生產(chǎn)） 目的：以模擬在正常生產(chǎn)情況下，凍干機(jī)能滿足凍干粉工藝要求 合格標(biāo)準(zhǔn)：產(chǎn)品質(zhì)量符合國(guó)家藥品標(biāo)準(zhǔn)WS1－（X－064）－2001Z 驗(yàn)證程序：依凍干機(jī)操作SOP，和產(chǎn)品的凍干工藝要求執(zhí)行，記錄下運(yùn)行時(shí)的相關(guān)參數(shù)，并對(duì)凍干后粉針進(jìn)行全檢，共做三批。七. 驗(yàn)證結(jié)論及評(píng)價(jià) 由驗(yàn)證小組依據(jù)驗(yàn)證報(bào)告進(jìn)行逐項(xiàng)的驗(yàn)證確認(rèn)后，根據(jù)檢測(cè)情況和數(shù)據(jù)統(tǒng)計(jì)進(jìn)行的分析判斷，并做出相應(yīng)的評(píng)價(jià) 由驗(yàn)證領(lǐng)導(dǎo)小組根據(jù)驗(yàn)證小組的報(bào)告發(fā)表審核意見，并簽署報(bào)告批準(zhǔn)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。 the second part is the interpretation of the two fundamental principles of the revision of laws and regulations in the party。 the fourth part on how to grasp the implementation of the two regulations of the party. code and Regulations revised the necessity and revised history of the CPC Central Committee the amendment to the Chinese Communist Party members and leading cadres honest politics several guidelines and Chinese Communist Party discipline and Punishment Regulations column 1 by 2015 to strengthen party laws and regulations focus. Two party regulations revision work lasted a Years, pooling the wisdom of the whole party, ideological consensus, draw historical experience, respect for the wisdom of our predecessors, which reflects the unity of inheritance and innovation。s leadership, to solve the masses of the people reflect a focus on the problem. The new revision of the code and rule , reflects the party39。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。 the third is banned terms and discipline law, both with the party discipline, disciplinary regulations repeat and Criminal law and other laws and regulations repeat。 two is the political discipline regulations is not prominent, not specific, for violation of the party constitution, damage the authority of Party Constitution of misconduct lack necessary and serious responsibility to pursue。s eighteen, ten eight plenary, the spirit of the Fourth Plenary Session of the Eleventh Central Committee and General Secretary Xi Jinping important instructions on the revised low political criterion and Regulations , highlighting the ruling party characteristics, serious discipline, the discipline quite in front of the law, based on the current, a longterm, advance as a whole, with Bu Xiuding independent rule and rule . Main principle is: first, adhere to the party constitution to follow. The constitution about discipline and selfdiscipline required specific, awaken the party constitution of party passes party consciousness, maintaining the authority of the constitution. General Secretary Xi Jinping pointed out that no rules, no side round. Party constitution is the fundamental la