主要用途与简价/Brief Introduction:
针剂使使水的装置针剂使使水的是纯化水经减压蒸馏所得的,真菌内毒物等公式均合适我国的药典针剂使使水的项下规定标准的水质标准需求,适用于糊口物医药集团公司中各种随便针剂入人内口服药的溶液。针剂使使水的装置具体属于针剂使使水的制法、循环系统存放、技术性分配比例和工艺设计操作等具体板块。
特别/Characteristic:
◆全自動的实操具体方法,必免职工误的实操带给的产量亏损;Automatic operation mode, to prevent losses of wrong operation of production;◆结构件通过316L面料;Components in 316L texture◆带PLC管控的CIP食品;CIP products with PLC control◆的记录与存有清理工作的规格与布骤;Record and save the parameters of the cleaning process and steps◆具备GMP的标准的可追述性与可说是明性; Meet GMP requirements traceability and accountability◆一体式化制作还有效合理节省位置;Integrated design can effectively save space◆体现生产方式和洗涤的更快的就能;Implement production and clean fast switching◆巴氏进行杀菌的,除污更齐全;Babbitt disinfection sterilization, cleaning more thoroughly◆多效萃取机:组装机压缩空气管道相连接方式全部的选取系统自动电焊焊接,按环境卫生级准则,阀体选取快卡相连接方式,杜决了注射器自来水的2次生态破坏;Multi-effect distillation machine: the machine connection all adopt the automatic welding, according to the level of healthstandard, the valve with fast connection, to eliminate the secondary pollution of water for injection◆纯蒸汽时有高压发生器时有高压发生器:PLC人与机器的操作把握软件界面,可0-100%电脑自动改善至必须要的总产值规范;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲区设定:注射液体饮用水程序整洁供水管道满意GMP3D需要,胶垫为PTPE/EPDM,隔离膜阀水平方向怎么装置时为90度,嵌套循坏供水管道怎么装置设为0.5的坡度比,设低开为摆放点,并用湍液的状态嵌套循坏流失的放置和输送管程序,解决微菌物的大量滋生;3 d design without dead Angle: clean water for injection system satisfies the requirement of GMP3D tube, rubber pad of PTPE/EPDM, when mounted horizontally is 45 degrees, the diaphragm valve loop pipeline installation set as 0.5 grade, set low emission points, and the turbulent fluid state circulating storage and conveying system, prevent microbes breeding◆齐全的信息操作控制系统:①信息包含GMP必须;②智能化操作操作控制系统可包含GAMP5;③3Q信息需求制药企业厂校验的须得。Complete the file system: (1) documents conform to GMP requirements; (2) automatic control system can meet GAMP5; (3) 3 q documents meet the needs of the pharmaceutical factory to verify◆人员配备高安全性能变频器泵用于卸料和配置注射器污水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热交换器,在纯化水长耗时反复的的过程 中更好地发挥空气冷却效果。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆填充冲水贮罐原则按照开式贮罐再就是卧试贮罐,实现运输泵潮位耍求,专业设有罐中水流量制止微生物膜导致。Injection water tank using vertical storage tank priority second horizontal tank, satisfies the requirement of pump water level, scientific setting tank velocity to prevent biofilm formation.◆适用80℃上文保温层重复设计制作,以防清水软件菌群制品大量滋生和影响。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配用感应起电加熱(液体加熱)透气过滤清洁器。Equipped with electric heating, steam heating) breathing filter◆罐底留水部位加设球形侧板以改变采海面,必免涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐组网主要采用氦气保护好,长期保持制药企业使用水儲存及分派程序压缩空气,解决办法第三方逆流被污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆药业有限公司开水气力输送机泵通过316L不銹钢制造出(浸水地方),电增加光泽并钝化处里。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系統加工具体步骤图
