应用领域与概述/Brief Introduction:
填充用清水机填充用清水是纯化水经分馏所得税率,有害菌内毒性等指标值均符合国家我国的药典填充用清水项下暂行规定的水环境条件,可当过活物医药集团行业中各种随便填充入躯干内药物剂量的有机溶剂。填充用清水机常见涵盖填充用清水制作、间歇处理、最新分发和生产技术控住等常见传感器。
优势特点/Characteristic:
◆全自己的的操作办法,以防止工作员误的的操作受到的制作亏损资金;Automatic operation mode, to prevent losses of wrong operation of production;◆元件选用316L质材;Components in 316L texture◆带PLC掌控的CIP护肤品;CIP products with PLC control◆备案与存为清洁工作具体步驟的参数设置与步驟;Record and save the parameters of the cleaning process and steps◆充分考虑GMP符合要求的可可追溯系统性与顾忌明性; Meet GMP requirements traceability and accountability◆合一化定制可以效大大节省区域空间;Integrated design can effectively save space◆构建制造和的清洁的短时间修改;Implement production and clean fast switching◆巴氏拆洗消毒,拆洗更充分;Babbitt disinfection sterilization, cleaning more thoroughly◆多效减压蒸馏机:整个机械滤油器连结全部的通过自己电焊焊接,按卫生防疫级细则,止回阀通过快卡连结,禁止了打污水的首次弄脏;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◆纯饱和蒸汽出现器:PLC人与机器方法操纵工具栏,可0-100%自己调准至要有的产能必须;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无方位方案:打冲水模式整洁蒸汽管道无法GMP3D特殊要求,胶垫为PTPE/EPDM,隔阂阀情况按照使用时为90度,反复装置管路按照使用设为0.5的倾斜,设低开为污染物点,即为湍液环境反复装置游动的存储和传输模式,以防止微怪物的滋生腐败;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◆全部的资料目录模式:①资料目录契合GMP条件;②智能化的控制模式可契合GAMP5;③3Q资料目录实现药厂厂认证的都要。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◆配发高效果变频柜泵以便输送带和左右肌注使用水进行。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器,在纯化水一直段循坏历程中有着冷却水帮助。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆皮下注射用热水贮罐为先主要采用垂直贮罐之后离心式贮罐,要推送泵低水位要,数学设备罐体风速严防生物技术膜生成。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℃往上保温层循环往复设计,解决办法水平台益生菌体存在和弄脏。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配齐感应起电采暖器(蒸汽式采暖器)呼吸道筛选器。Equipped with electric heating, steam heating) breathing filter◆罐底出水量口加设圆锥形档板以扩张采河面上,以避免电磁感应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐和接入所采用氢气呵护,维系制药厂污水存储及配资体统 压,制止其他循环被污染的。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药业用纯净水运送泵适用316L不锈钢圆管生产(浸水的部分),电抛光处理并钝化处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系统生产技术步骤图
