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注射用水设备

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应用场景与详细资料/Brief Introduction:


注塑需要使拿水量进行设备注塑需要使拿水量进行是纯化水经减压蒸馏所获资金,真菌内黑色素等质量指标均适用全球药典注塑需要使拿水量进行项下中规定的地表水规定,可以作为过活物医药化工公司企业中特殊会注塑入机体内用药的液体。注塑需要使拿水量进行设备最基本包涵注塑需要使拿水量进行提纯、反复的放置、动态的分摊和加工工艺操控等最基本引擎。


共同点/Characteristic:


◆全自行基本运营行为,避免相关人员误基本运营带给的生产方式损失率;Automatic operation mode, to prevent losses of wrong operation of production;◆组件利用316L金属材质;Components in 316L texture◆带PLC有效控制的CIP服务;CIP products with PLC control◆登记与保持清洁时的技术参数与布骤;Record and save the parameters of the cleaning process and steps◆能够满足GMP规定的可朔源性与言说明性; Meet GMP requirements traceability and accountability◆一体式化规划但是有效节省了办公空间;Integrated design can effectively save space◆达到工作和净化的迅速锁定;Implement production and clean fast switching◆巴氏的洗涤杀菌的,的洗涤更撤底;Babbitt disinfection sterilization, cleaning more thoroughly◆多效蒸溜机:该机液压管路对接所有选择自主焊接方法,按安全级规范,调节阀选择快卡对接,应对了填充污水的三次造成的污染;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◆纯液体引发器:PLC组队操作流程控住工具栏,可0-100%自然控制至所需的出产量特殊要求;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲点的设计:肌注加水系統美观滤油器提供GMP3D需求,胶垫为PTPE/EPDM,膈膜阀能力布置时为四十五度,重复线管布置设为0.5的道路倾斜度,设低一点为排出点,并用湍液状况重复传递的储存室和输送机系統,杜绝细小微生物制品的引起;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◆详细完整的档案平台:①档案达到GMP让;②全智能工业操作平台可达到GAMP5;③3Q档案符合农药厂厂检验的可以。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◆具备高功能定频泵借以输送管和配资注入纯净水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器,在纯化水长日子反复进程中有冷却水功效。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆针剂拿水贮罐必需应用直列V型贮罐前者柜式贮罐,实现传输泵三峡水位耍求,科学课制定罐体流动速度放置微生物膜建立。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.◆采用了80℃及以上隔温再循环设定,严防用水的软件微益生菌滋生腐败和污染源。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配发感应起电预热(水汽预热)吸过虑器。Equipped with electric heating, steam heating) breathing filter◆罐底有水出口加设圆锥形挡片以减少采冰面,以避免涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐和接入通过氢气防护,达到药厂用清水储放及调整系统性送风机,可以防止表面出液水污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆医药使用水输送带泵用到316L不锈钢板生产制造(浸水区域),电磨光并钝化办理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment


三、机系统工艺工作流程工作程序流程图