应用场景与百科/Brief Introduction:
滴注开水主的设备滴注开水是纯化水经分馏所获资金,沙门氏菌内内毒素等指标值均贴合我们药典滴注开水项下相关规定的地表水特殊要求,能以糊口物化工各个企业中以及随时滴注入躯干内药的液体。滴注开水主的设备常见包含滴注开水制法、巡环贮藏、动态图片计算和方法管控等常见传感器。
基本特征/Characteristic:
◆全自然基本操作的原则,严防员工误基本操作的造成 的产出失去;Automatic operation mode, to prevent losses of wrong operation of production;◆安全装置采用了316L不锈钢材质;Components in 316L texture◆带PLC的控制的CIP产品的;CIP products with PLC control◆统计与留存洗涤步聚的数据与步聚;Record and save the parameters of the cleaning process and steps◆做到GMP要的可产品追溯性与可说是明性; Meet GMP requirements traceability and accountability◆立体式化的设计但是有效合理节省发展空间;Integrated design can effectively save space◆确保制作和干净的的迅猛锁定;Implement production and clean fast switching◆巴氏清洁室内消毒,洗涤更彻底删除文件;Babbitt disinfection sterilization, cleaning more thoroughly◆多效蒸溜机:一整台机器的管道管道阀门连入方式所有用半自动手工焊接,按卫生监督级原则,管道阀门用快卡连入方式,处理了滴注冲水的两次环保问题;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◆纯液体发生的器:PLC组排操作使用控制工具栏,可0-100%自动化调接至要有的产品量要;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲点设计制作:注射器需要用水平面台干净干燥聚氨酯保温管需要满足GMP3D让,胶垫为PTPE/EPDM,pu气管阀水平面配置时为四十五度,循坏输油管线配置设为0.5的相对高度,设低一点为进行排放点,并且以湍液情况循坏流通的存放和传输平台,解决办法微海洋生物的引起;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◆完正的信息模式性:①信息贴合GMP的标准;②智能化调控模式性可贴合GAMP5;③3Q信息无法药业厂查验的必须要 。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◆选配高功能直流变频泵主要用于卸料和分配原则注射器用纯净水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热交换器器,在纯化水长时长配置环节中充当散热使用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆皮下注射饮用水贮罐原则主要包括落地贮罐再就是卧试贮罐,考虑传输泵水量必须,科学有效设计碱罐流动速度解决动物膜演变成。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.◆使用80℃大于墙体保温嵌套循环设汁,必免需要用水模式微生物学制品滋生腐败和生态破坏。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆设备带电体水汽采暖器(水汽水汽采暖器)深呼吸过滤装置器。Equipped with electric heating, steam heating) breathing filter◆罐底满水后口加设锥型挡片以变大采水中,防范涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐对接进行氢气爱护,确保生物制药拿水存放及计算系统的送风机,必免其他分流水污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆药业使用水进行运送泵采取316L不锈钢材质的开发(浸水那部分),电抛光正确处理并钝化正确处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系统性加工方案图
