【正文】
3. Among them, add, delete, modify the provisions of the proportion of up to nearly 90%. 1, the general general is divided into five chapters. The first chapter to the regulations of the guiding ideology, principles and scope of application of the provisions, highlight the strengthening of the party constitution consciousness, maintenance the authority of Party Constitution, increase the party organizations and Party members must abide by the party constitution, Yan Centralized centralized, would examine at all levels of the amended provisions implementing and maintaining Party discipline, and consciously accept the party discipline, exemplary pliance with national laws and regulations. The second chapter of discipline concept, disciplinary action types and effects of the regulations, will be a serious warning from the original a year for a year and a half。 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。驗證程序:按以上要求進(jìn)行測試測試結(jié)果:結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:檢測大蝶閥的氣密性。數(shù)據(jù)記錄: 見附錄四結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:通過對真空度上升速度的測定,判斷真空系統(tǒng)工作性能是否符合設(shè)計要求合格標(biāo)準(zhǔn):凍干箱加熱至干燥狀態(tài),冷凝器溫度小于50℃時,真空度自一個大氣壓升高到10Pa時,所需要的時間小于30min。1℃。② 電氣設(shè)備和機械的所有裸露導(dǎo)線都應(yīng)接到保護(hù)接地電路上。平整度為177。濕度要求40%~80%?!评湎到y(tǒng):采用壓縮機組,每套均有獨立的循環(huán)系統(tǒng),即可制冷板層,又能制冷冷凝器,其中任何一套系統(tǒng)出故障,機器仍可正常工作。這一階段是為了除去制品中的殘留水份,以延長其保存性。類別檢測標(biāo)準(zhǔn)相關(guān)標(biāo)準(zhǔn)資料實測真空管路1. 采用不銹鋼管(檢測時依據(jù)供貨 單位提供的質(zhì)量保證書)。數(shù)據(jù)記錄: 見附錄二結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: (冷媒)升溫速率 驗證目的:檢查并確認(rèn)板層(冷媒)的升溫速率符合設(shè)計要求。合格標(biāo)準(zhǔn):最大捕水量200kg驗證程序:在平底托盤中加入厚度不超過10mm的注射用水,(最好用敞口西林瓶盛水)分別置于隔板上,記錄下總水量(kg),按照凍干機使用標(biāo)準(zhǔn)操作規(guī)程,對注射用水進(jìn)行真空干燥。 follow the correct direction, grasp the limited goals, adhere to the party39。s advanced nature and purity. 1, respect for the constitution, refinement and discipline. Revised rule from prehensive b physical constitution began, the party constitution and other regulations of the Party of Party organizations and Party discipline requirements refinement, clearly defined in violation of the party constitution will be in accordance with regulations to give the corresponding disciplinary action. The original 10 categories of misconduct, integration specification for political discipline, discipline, honesty and discipline masses Ji Law and discipline and discipline and other six categories, the content of rule real return to Party discipline, for the majority of Party members and listed a negative list. 7 2, highlighting the political discipline and political rules. Regulations according to the stage of the discipline of outstanding performance, emphasizing political discipline and political rules, organization and discipline, in opposition to the party39。s basic theory, basic line, basic program and basic experience, the basic requirement of behavior made prescribed punishment, increase the cliques, against the organization such as violation of the provisions, to ensure that the central government decrees and the Party of centralized and unified. 3, adhere to strict discipline in the law and discipline In front, Ji separated. Revised Regulations adhere to the problem oriented, do Ji separated. Any national law existing content, will not repeat the provisions, the total removal of 79 and criminal law, repeat the content of the public security management punishment law, and other laws and regulations. In the general reiterated that party organizations and Party members must conscientiously accept the party39。s 18 and the eighth session of the third, the spirit of the fourth plenary session, reflecting the experience of studying and implementing the General Secretary Xi Jinping series of important speech, reflects the party39。最大捕水量=總注射用水量一殘留注射用水量。對凍干機板層升溫速率進(jìn)行評價。(是否符合材料配置要求)(檢測其是否符合施工圖紙要求)循環(huán)管路(檢測時依據(jù)供貨單位提供的質(zhì)量保證書)。當(dāng)制品的含水量達(dá)到標(biāo)準(zhǔn)時,二次干燥即可結(jié)束,周期完成。——控制系統(tǒng):系統(tǒng)連鎖保護(hù),以防止不必要的誤操作。安裝環(huán)境要求廠房承載能力大于1000kg/m2,廠房內(nèi)不能有腐蝕性和易燃易爆的氣體,地面平整牢固,不需預(yù)埋地腳。:——干箱體和板層及熱交換系統(tǒng)材料選用:優(yōu)質(zhì)的AISI316L不銹鋼。 文件名稱存放地點檢查人日期產(chǎn)品質(zhì)量證明書出廠檢驗報告用戶驗收報告凍干機配套設(shè)備資料 平面布置圖工藝流程圖驗證方案、IQ、OQ文件凍干機技術(shù)說明凍干機使用說明凍干機維護(hù)說明結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 二. GZLYZ20(CIP、SIP)真空冷凍干燥機安裝確認(rèn)安裝確認(rèn)是檢查其是否符合GMP要求的確認(rèn)環(huán)節(jié),對照使用說明書,確認(rèn)其環(huán)境要求、安裝程序和方法能保證設(shè)備良好運行,并如何校正各種工藝參數(shù),以此來保證達(dá)到生產(chǎn)的要求,使設(shè)備達(dá)到最佳運行狀態(tài)目的:確認(rèn)設(shè)備的主要配件的規(guī)格符合設(shè)計要求名 稱規(guī) 格數(shù) 量生 產(chǎn) 廠 家 實 測 結(jié) 論壓縮機Z302臺意大利Frdscold真空泵E2M802臺英國愛德華羅茨泵EH12001臺英國愛德華循環(huán)泵UPS65-180F雙聯(lián)1臺GRUNDFOS液壓泵一組1臺臺灣達(dá)眾水冷冷凝器2臺水環(huán)泵2BV20701臺德國西門子(山東)板式交換器CB7642HX2臺瑞士舒維普PLCFN21套日本三菱結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:確認(rèn)設(shè)備所用材質(zhì)符合GMP的要求,采用不銹鋼材料項 目要 求實 測結(jié) 論凍干箱AISI316L擱板AISI316L冷凝器AISI316L外裝飾板AISI304密封門304L結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目的:確認(rèn)設(shè)備的各種公用介質(zhì)安裝符合設(shè)計要求名稱技術(shù)指標(biāo)接管材質(zhì)實測結(jié)論管徑連接方式用量總電源三相五線制90KW380V/50Hz冷卻水管螺紋(連接外螺紋)20噸/小時t≤25℃P≥鍍鋅管壓縮空氣1/4p≥化霜水、清洗水ISO253噸/小時P≥2kg/cm2不銹鋼管總放水管KF50鍍鋅管水環(huán)泵排水管管螺紋(連接內(nèi)螺紋)溢流管ISO25鍍鋅管真空泵排氣管φ32鍍鋅管結(jié)論:執(zhí)行人: 日期: 復(fù)核人: 日期: 目