使用用途与介简/Brief Introduction:
滴注污水的的量设配滴注污水的的量是纯化水经分馏所有,细菌病毒内毒性等指标英文均按照华人药典滴注污水的的量项下暂行规定的水环境符合要求,适用于维持生计物药业有限公司机构中四种会滴注入人内口服药物的溶液。滴注污水的的量设配最核心还有滴注污水的的量化学合成、重复放置、动态图片平均分配和方法操控等最核心电源模块。
优势/Characteristic:
◆东莞激光切割管机化工作方试,以防员工误工作面临的生产方式折损;Automatic operation mode, to prevent losses of wrong operation of production;◆控制部件用到316L木头材质;Components in 316L texture◆带PLC管控的CIP车辆;CIP products with PLC control◆记录好与保护洗方式的指标与过程;Record and save the parameters of the cleaning process and steps◆考虑GMP规范的可追述性与言说明性; Meet GMP requirements traceability and accountability◆分离式化装修设计可以效增加前景;Integrated design can effectively save space◆进行产量和洁面的短时间调成;Implement production and clean fast switching◆巴氏消毒液除菌,清洁更根除;Babbitt disinfection sterilization, cleaning more thoroughly◆多效水蒸气蒸馏机:组装机蒸汽管道连入都是运用一键氩弧焊,按食品卫生级标准的,单向阀运用快卡连入,解决了针剂用清水的重新污染问题;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◆纯蒸气产生器:PLC组队使用把控菜单栏,可0-100%电脑自动转换至的标准的时产的标准;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无任何死角方案:针剂用自来水整体干净内部管道足够GMP3D的标准,胶垫为PTPE/EPDM,膈膜阀总体水平配置时为50度,循坏输水管线配置设为0.5的纵坡,设低开为产生点,仅以湍液状态下循坏传播的储藏和气力输送机整体,阻止微生物发酵学的孳生;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◆删改的档案名称下载平台的:①档案名称下载符合要求国家GMP必须;②重新化控制平台的可符合要求国家GAMP5;③3Q档案名称下载要求药业厂证实的都要。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◆购置高能直流变频泵主要用于气力输送机和合理安排注谢水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板传热器,在纯化水长事件巡环操作过程中具有制冷用处。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注入纯净水贮罐优先级进行开式贮罐次之离心式贮罐,的标准推送泵水温的标准,有效设备碱罐流体密度解决菌物膜型成。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.◆用到80℃这隔温配置开发,阻止用自来水整体微怪物形成和水污染。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆搭载感应起电采暖器(液体采暖器)感受不到全自动过滤器中器。Equipped with electric heating, steam heating) breathing filter◆罐底出液口加设圆锥形挡片以变大采表面,阻止涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐组网用于N2保护英文,能维持医药化工用清水店铺及划分机系统正压力,以防外界循环感染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆生物制药纯净水运输泵主要采用316L冷库保温隔热板的表层生产制造(浸水部位),电拋光并钝化处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、程序生产技术环节图
