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葡萄糖注射液的生產流程及設備-文庫吧

2025-05-23 05:51 本頁面


【正文】 0。 主要技術參數(shù): 生產能力:60200瓶/分 容器規(guī)格:201000ml圓柱形玻璃瓶或金屬聽 標簽規(guī)格:120300mm(最大) 電機功率:2Kw380v50Hz 外形尺寸:28009501100(長寬高) 機器凈重:800kg設備名稱處理量外形尺寸(長寬高)單機重量(kg)備注QG180型啟蓋機60200瓶/分10106601200800QJW6型外洗機30200瓶/分7505501320300QJB24(16)型超聲波洗瓶機60400瓶/分(20200瓶/分)5470360020006000GFA1型灌封機2060瓶/分2000150018005002臺SP上瓶機60200瓶/分5000220030001200XP卸瓶機60200瓶/分2500350030001200SDJ30/100燈檢機50200瓶/分鐘2500350030001000QCS系列全自動膠塞清洗機60200瓶/分2500160019001800TNZ200型直線式貼標機6020瓶/分28009501100800總結大輸液是通過靜脈滴定輸入體內的大劑量注射液,使用時通過輸液器調整滴速,持續(xù)而穩(wěn)定的進入靜脈以補充體液、電解質或提供營養(yǎng)物質。近年又出現(xiàn)了治療性輸液。大輸液在臨床上主要用于重危癥患者的搶救和治療由于直接靜茹血液具有藥效迅速、作用可靠和易于控制等優(yōu)點。葡萄糖注射液屬注射劑,是調節(jié)水鹽、電解質及酸堿平衡藥。可以補充能量和體液;用于各種原因引起的進食不足或大量體液丟失(如嘔吐、腹瀉等),全靜脈內營養(yǎng),饑餓性酮癥。工藝設備設計與選型分兩個階段,第一階段包括以下內容:①定型機械設備和制藥機械設備的選型;②計量貯存容器的計算:③定型化工設備的選型;④確定非定型設備的形式、工藝要求、臺數(shù)、主要規(guī)格。第一階段是解決工藝過程中的技術問題,例如過濾面積、傳熱面積、干燥面積以及各種設備的主要規(guī)格等。車間布置是車間工藝設計的一個重要環(huán)節(jié),它還是工藝專向其他非工藝專業(yè)提供開展車間設計的基礎資料之一。一個不合理的車間基建時工程造價高,施工安裝不便;車間建成后又會帶來生產和管理的問題,造成人流和物流紊亂,設備維修合法檢修不便,增加輸送物料的能耗,且容易發(fā)生事故。因此,車間布置設計應遵守設計程序,按照布置設計的基本原則,進行細致而周密的考慮。為規(guī)范藥品生產質量管理,根據(jù)《中華人民共和國藥品管理法》、《中華人民共和國藥品管理法實施條例》,制定本規(guī)范。企業(yè)應當建立藥品質量管理體系。該體系應當涵蓋影響藥品質量的所有因素,包括確保藥品質量符合預定用途的有組織、有計劃的全部活動。本規(guī)范作為質量管理體系的一部分,是藥品生產管理和質量控制的基本要求,旨在最大限度地降低藥品生產過程中污染、交叉污染以及混淆、差錯等風險,確保持續(xù)穩(wěn)定地生產出符合預定用途和注冊要求的藥品。企業(yè)應當嚴格執(zhí)行本規(guī)范,堅持誠實守信,禁止任何虛假、欺騙行為。參考文獻(M).北京:化學工業(yè)出版社,2010。,(M).北京:化學工業(yè)出版社,2007。(M).北京:石油工業(yè)出版社,2002。,:化工制圖(M).北京:化學工業(yè)出版社,2008。(M).北京:化學工業(yè)出版社,2009。6. 《GMP》規(guī)范。7. 花仲卉,林嘉民,[ J ] ,海峽藥學,2003,15(5):145148 8.中國藥典 2005版。9.崔福德. .藥劑學【M】.第三版,北京。人民衛(wèi)生出版社,2003。 10. 【S】,1998。11. 【M】.北京。化學工業(yè)出版社,12. 國家藥事管理局醫(yī)藥工業(yè)潔凈廠房設計規(guī)范,附錄一:附錄二:工藝流程及環(huán)境區(qū)域劃分示意圖附錄三:62(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。 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 part is the interpretation of the two fundamental principles of the revision of laws and regulations in the party。 the third part introduces two party regulations modified the main changes and needs to grasp several key problems。 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。 follow the correct direction, grasp the limited goals, adhere to the party39。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 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。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 second is concisely positive advocated by the lack of prohibited provisions excessive, no autonomy requirements。 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。 the fourth is to clean the theme is not prominent, not for the existing problems, and is narrow, only needle of countylevel leading cadres above. rule is in 1997 Chinese Communist Party disciplinary cases (Trial) based on revision, in December 2003 the promulgation and implementation, to strengthen the construction of the party play very important role. Along with the development of the situation, which many provisions have been unable to fully meet the prehensive strictly administering the practice needs. One is Ji law, more than half of the provisions and criminal law and other countries laws and regulations Repetition。 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。 third is the main discipline for the leading cadres, does not cover all Party members. Based on the above situation, need to the criterion of a clean and honest administration and rule the two is likely to be more relevant regulat
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