应用场景与简单/Brief Introduction:
打冲水机械设备打冲水是纯化水经水蒸气蒸馏所得税率,菌内毒性等质量指标均符合标准中国内地药典打冲水项下指定的水体质量让,用做为食物制作药品行业中各间接打入机体内性药物的高沸点溶剂。打冲水机械设备主耍的属于打冲水制取、反复的保存、动态展示确定和方法抑制等主耍的引擎。
性能/Characteristic:
◆自动的进行策略,解决办法工作人员误进行引发的生产的毁损;Automatic operation mode, to prevent losses of wrong operation of production;◆机械部件使用316L质量;Components in 316L texture◆带PLC把控的CIP產品;CIP products with PLC control◆的记录与维持清理时的技术参数与步数;Record and save the parameters of the cleaning process and steps◆够满足GMP想要的可追朔性与可聊明性; Meet GMP requirements traceability and accountability◆立体式化设计方案有效避免浪费环境;Integrated design can effectively save space◆变现产出和除污的快就能;Implement production and clean fast switching◆巴氏消毒液灭菌,冲洗更恢复原状;Babbitt disinfection sterilization, cleaning more thoroughly◆多效萃取机:该机液压管路进行联系其他使用自动式电弧焊接,按环境卫生级标准,电动阀门使用快卡进行联系,制止了肌内注射加水的四次严重污染;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◆纯蒸气遭受器:PLC人机对战操作方法操控软件界面,可0-100%主动改善至可以的产品量追求;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲区构思:接种用纯净水系统化净化内部管道能够满足GMP3D条件,胶垫为PTPE/EPDM,隔阂阀品质装置时为90度,反复输油管线装置设为0.5的坡度系数,设最低点为排放标准点,并且以湍液阶段反复游动的茶叶保存和运输系统化,控制微生物检测工程的生长;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◆完全的资料软件:①资料符合国家国家GMP特殊要求;②全智能化以及自动化操作管理软件可符合国家国家GAMP5;③3Q资料要求药厂厂安全验证的必须。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◆标准配备高使用性能直流变频泵用为输送带和配置针剂使用水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板管壳式换热器器,在纯化水长准确时间循环往复期间中带来冷却水用处。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注射器用热水贮罐优先级用到垂直贮罐接下来水平贮罐,满足了气流输送泵水温追求,合理制定罐里流动速度控制怪物膜变成。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.◆用于80℃上面墙体保温嵌套循环设置,可以防止用水量系统性微菌物繁衍和严重污染。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配有带电体微波升温(空气压缩微波升温)喘气净化器。Equipped with electric heating, steam heating) breathing filter◆罐底出液口加设圆锥形侧板以放大采海面,避免 涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐接入网利用离氮气呵护,持续药厂用水量处理及左右控制系统 压,杜绝其他出液废弃物。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆医药开水输料泵采取316L不锈钢装饰管造成(浸水部件),电cnc精密机械加工并钝化加工处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、软件艺步骤图
