的用途与详细资料/Brief Introduction:
填充需要加水的专用设备填充需要加水是纯化水经减压蒸馏所获资金,细菌病毒内内毒素等目标均包含华人药典填充需要加水项下标准要求的水硬度标准要求,需用养家糊口物医药化工工厂中各可以直接填充入人体健康内类药的容剂。填充需要加水的专用设备最重点的收录填充需要加水制取、循环往复处理、动态展示分配权和流程把控等最重点的功能模块。
特别/Characteristic:
◆全会自动操作步骤流程行为,严防的人员误操作的可能步骤流程引来的产生折损;Automatic operation mode, to prevent losses of wrong operation of production;◆部位通过316L布料材质;Components in 316L texture◆带PLC把握的CIP好产品;CIP products with PLC control◆数据与保护进行维护清洁过程中 的指标与过程;Record and save the parameters of the cleaning process and steps◆符合GMP特殊要求的可溯源性与可聊明性; Meet GMP requirements traceability and accountability◆分立式化设计的概念但是有效合理安排环境;Integrated design can effectively save space◆确保生产方式和清洁卫生的快捷切回;Implement production and clean fast switching◆巴氏紫外线消毒除臭,清晰更完全;Babbitt disinfection sterilization, cleaning more thoroughly◆多效分馏机:空机输送管联系全运用会自动焊接加工,按干净卫生级规格,管道阀门运用快卡联系,遏制了针剂用热水的再次环境污染;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◆纯蒸汽突发器突发器:PLC人机对战运营操纵软件界面,可0-100%自动化改善至应该的总产值请求;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲区设计构思:肌内注射用热水整体洁净间线路需求GMP3D规范,胶垫为PTPE/EPDM,隔离膜阀含量布置时为50度,反复的往复线管布置设为0.5的纵坡,设最低值为进行排放点,仅以湍液阶段反复的往复流通的茶叶保存和运送整体,解决办法微怪物的繁衍;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◆完善的压缩压缩文件夹软件:①压缩压缩文件夹按照GMP的要求;②主动化抑制软件可按照GAMP5;③3Q压缩压缩文件夹满意医药集团厂验证通过的所需。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交流变频泵从而输送带和划分滴注水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板传热器,在纯化水长事件配置流程中带来冷却后效果。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注入自来水贮罐优先级使用直列V型贮罐次之柜式贮罐,充分考虑传输泵地下水位的标准,有效软件设置罐体风速杜绝海洋生物膜行成。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.◆采取80℃往上保热嵌套循环结构设计,放到用水量设备菌群工程繁衍和危害。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆常备带电体升温(饱和蒸汽升温)吸呼进行过滤。Equipped with electric heating, steam heating) breathing filter◆罐底冒水口镇加设圆锥形档板以发展采河面上,阻止涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐连结采用了离氮气保護,保护制药业开水贮藏及配置装置 压,解决办法外观分流污染源。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆医药清水输料泵所采用316L不锈钢材质创造(浸水个部分),电打磨抛光并钝化正确处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、整体标准流程标准流程表
