种类与概述/Brief Introduction:
打开水机器装备打开水是纯化水经分馏所得税,日常细菌内毒性等标准均按照国家药典打开水项下规范的水污染想要,能以谋生物化工企业的中各种类型直接的打入机体内用量的有机溶剂。打开水机器装备大部分其主要包括打开水分离纯化、重复存储、动态图分派和生产工艺把控好等大部分版块。
特质/Characteristic:
◆全自然的操作使用办法,以免工作员误的操作使用所带来的分娩损耗;Automatic operation mode, to prevent losses of wrong operation of production;◆构件主要采用316L才质;Components in 316L texture◆带PLC掌控的CIP物品;CIP products with PLC control◆的记录与保护家电清洗工作的技术指标与布骤;Record and save the parameters of the cleaning process and steps◆满足需要GMP规定要求的可溯源性与可聊明性; Meet GMP requirements traceability and accountability◆二合一化装修设计还有效节省成本空间区域;Integrated design can effectively save space◆确保生产的和净化的加快修改;Implement production and clean fast switching◆巴氏消毒剂消菌,擦拭更充分;Babbitt disinfection sterilization, cleaning more thoroughly◆多效分馏机:空机输送管进行相连接大部分通过智能熔接,按健康级基准,闸阀通过快卡进行相连接,拒绝了接种污水的再次被污染;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◆纯饱和蒸汽发生了器:PLC电脑操作的调控操作界面,可0-100%一键设定至要有的出现想要;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无㓟盲区方案:注射器用自来水系统软件软件洁净并用管路做到GMP3D标准要求,胶垫为PTPE/EPDM,膈膜阀总体水平施工时为50度,循环往复系统软件管路施工设为0.5的相对高度,设低开为尾气排放标准点,同时以湍液情形循环往复系统软件流量的低温干燥和传输系统软件软件,处理微生物发酵制品的泛滥;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◆全部的相关文档下载系統:①相关文档下载完全符合标准要求GMP标准要求;②一键化管理系統可完全符合标准要求GAMP5;③3Q相关文档下载要有满足医药集团厂效验的要有。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◆标准配置高特性交流变频泵加以输送带和分摊肌内注射需要用水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热换器器,在纯化水长時间嵌套循环全过程中具有加热影响。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆皮下注射供水贮罐首先通过落地式贮罐第二立式贮罐,提供传送泵水位线标准,地理学设有罐中空气流速放到生物体膜出现。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℃不低于隔热不断循环装修设计,放到使用水进行设备微动物滋长和环保问题。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆添置感应起电加温(过热蒸汽加温)呼气油烟净化器器。Equipped with electric heating, steam heating) breathing filter◆罐底有水出口加设椎型挡片以不断扩大采河面上,制止电磁。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐联网用离氮气爱护,确保生物制药自来水储藏及分销系统性送风机,避免 对外部出液严重污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆药业有限公司清水输送管泵选用316L304不绣钢营造(浸水这部分),电抛光清理并钝化清理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系统性制作工艺操作流程图模板
