的主要用途与筒介/Brief Introduction:
滴注加水机器机械设备滴注加水是纯化水经萃取所述,微生物内毒性等指标体系均遵循全国药典滴注加水项下标准的水体质量需求,能以养家糊口物药业品牌中几大类可以直接滴注入人的身体内肿瘤药物的有机溶剂。滴注加水机器机械设备重点还包括滴注加水提纯、循环系统存贮、的动态确定和工艺设备操作等重点信息模块。
性能/Characteristic:
◆全会自动方法的方式,处理考生误方法提供的研发经济损失;Automatic operation mode, to prevent losses of wrong operation of production;◆配件选用316L原料;Components in 316L texture◆带PLC管理的CIP商品;CIP products with PLC control◆登记与存储的洗涤历程的性能参数与步驟;Record and save the parameters of the cleaning process and steps◆无法GMP的要求的可产品追溯性与顾忌明性; Meet GMP requirements traceability and accountability◆三合一化构思还有效降低成本空间区域;Integrated design can effectively save space◆建立研发和保洁的迅猛添加;Implement production and clean fast switching◆巴氏消菌消菌,刷洗更彻底清除;Babbitt disinfection sterilization, cleaning more thoroughly◆多效减压蒸馏机:该机输送管接触所有 适用定时点焊,按安全级标准的,调节阀适用快卡接触,制止了滴注用纯净水的2次被污染;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◆纯蒸气发生了器:PLC组队运作抑制游戏界面,可0-100%自己调整至必须 的产销量的标准;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无墙边制作:打水体统美观输料管满足了GMP3D请求,胶垫为PTPE/EPDM,膈膜阀程度装有时为50度,配置管道装有设为0.5的相对高度,设低开为排卸点,同时以湍液感觉配置外溢的储存和输料体统,解决办法微生物当中工程的泛滥;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◆完善的信息平台:①信息贴合GMP条件;②自主化操作平台可贴合GAMP5;③3Q信息够满足医药集团厂检验的是需要。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◆标准配置高使用性能直流变频泵主要用于输送管和配置填充用自来水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器,在纯化水长时期重复时中具备闭式冷却塔用处。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆接种污水贮罐为先用落地贮罐此外柜式贮罐,足够输送机泵水平线要,科学课设置成罐体气速处理菌物膜演变成。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.◆进行80℃上述墙体保温嵌套循环结构设计,处理加水机系统微动物产生和被污染的。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配有有电烧水(过热蒸汽烧水)呼气水过滤器器。Equipped with electric heating, steam heating) breathing filter◆罐底有水出口加设椎型挡片以拓展采冰面,可以防止涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐连结分为N2爱护,达到制药企业开水吸收及合理安排系统性 压,可以防止外部链接出液感染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药厂使用水进行推送泵运用316L不锈钢304手工制造(浸水一部分),电磨光并钝化除理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、设计加工工艺环节图
