功用与百科/Brief Introduction:
填充需要纯净水设施的设备填充需要纯净水是纯化水经减压蒸馏所有,螨虫内黑色素等统计指标均遵循中国内地药典填充需要纯净水项下的规定的饮需要用水的标准要求,用于为业物制药客户客户中各会填充入机体内用量的相转移催化剂。填充需要纯净水设施的设备其主要是以及填充需要纯净水制得、重复放置、日常动态配资和工艺设计抑制等其主要是模块图片。
作用/Characteristic:
◆全半自动的方法手段,解决人误的方法分享的生产方式消耗;Automatic operation mode, to prevent losses of wrong operation of production;◆部件通过316L板材;Components in 316L texture◆带PLC的控制的CIP商品;CIP products with PLC control◆记录表与保留的清洗时候的因素与环节;Record and save the parameters of the cleaning process and steps◆充分满足GMP想要的可朔源性与可以说明性; Meet GMP requirements traceability and accountability◆整体化的设计有效节约开支位置;Integrated design can effectively save space◆达到生产制造和擦洗的快修改;Implement production and clean fast switching◆巴氏室内消毒室内消毒消毒,清晰更彻彻底底;Babbitt disinfection sterilization, cleaning more thoroughly◆多效减压蒸馏机:整套装置蒸汽管道连到另一个适用自行焊,按卫生防疫级标准的,阀体适用快卡连到,避免出现了针剂需要用水的首次严重污染;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◆纯饱和蒸汽突发器:PLC组排操作步骤管理表面,可0-100%系统自动调控至须要的产出量标准;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无任何死角来设计:皮下注射饮用水程序净化后的压缩空气管道满意GMP3D追求,胶垫为PTPE/EPDM,膈膜阀含量组装时为90度,间歇往复输水管线组装设为0.5的坡度系数,设低些为排出点,并且以湍液状况间歇往复流动量的茶叶保存和输送带程序,防范微动物的存在;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◆完整详细的材料资料软件模式:①材料资料达到GMP需求;②自行化设定软件模式可达到GAMP5;③3Q材料资料需求满足冶炼厂厂核实的需求。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交流变频泵用来运送和分派注射器用自来水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器,在纯化水长的时间循环往复时中发挥着保压做用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆打清水贮罐合理采用了立柱式贮罐第二水平贮罐,具备输送机泵低水位请求,科学研究设立罐体流动速度避免 微生物膜演变成。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.◆按照80℃之内保温层循环体统设计构思,控制用水的体统生物学体蔓延和污染破坏。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配有导电进行受热(压缩空气进行受热)深呼吸油烟净化器器。Equipped with electric heating, steam heating) breathing filter◆罐底出水出水部位加设圆锥形隔板以扩张采海面,必免涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐联网主要包括离氮气保障,长期保持药业需要用水保存及管理系统化+压,控制第三方流回的污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆医药用自来水气力输送机泵分为316L不銹钢制造厂(浸水的部分),电抛光办理并钝化办理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、操作系统的工艺工艺操作流程
