功用与简绍/Brief Introduction:
滴注自来水仪器滴注自来水是纯化水经减压蒸馏获得的,细菌和病毒内毒性等条件均适合在我国药典滴注自来水项下标准规定的水质检测条件,可以作为为业物医药化工各个企业中四种随时滴注入人體内药剂的石油醚。滴注自来水仪器最最主要涉及滴注自来水配制、巡环保管、日常动态调整和新工艺把握等最最主要模组。
基本特征/Characteristic:
◆全智能控制原则,以免的人员误控制所带来的制作经济损失;Automatic operation mode, to prevent losses of wrong operation of production;◆结构件使用316L材料;Components in 316L texture◆带PLC调整的CIP的产品;CIP products with PLC control◆登记与存放洗的过程的基本参数与步骤之一;Record and save the parameters of the cleaning process and steps◆足够GMP规范要求的可追溯性与可说是明性; Meet GMP requirements traceability and accountability◆分离式化制作有没有效增加前景;Integrated design can effectively save space◆保证生育和除污的高速切换桌面;Implement production and clean fast switching◆巴氏酒精消毒除臭,清晰更彻彻底底;Babbitt disinfection sterilization, cleaning more thoroughly◆多效减压蒸馏机:一整台机器的蒸汽管道链接全部的进行自功悍接,按健康级的标准,气动阀门进行快卡链接,拒绝了注塑用水的的三次环境破坏;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◆纯饱和蒸汽会等离子发生器:PLC组排作业调低表面,可0-100%全自动调低至需求的销售量要;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无方位设计方案:注射器用水量体统洁净室管网够满足GMP3D耍求,胶垫为PTPE/EPDM,隔阂阀水准重新按装时为四十五度,无限巡环管网重新按装设为0.5的坡度比,设底点为排放标准点,即为湍液阶段无限巡环进出的存放和气流输送体统,以避免微怪物的形成;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◆详尽的相关档案名机系統:①相关档案名达到GMP规范;②自己化保持机系統可达到GAMP5;③3Q相关档案名需求药厂厂确认的需求。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◆选配高耐磨性变频柜泵用于运输和分摊打针清水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板式换热器器,在纯化水长时刻巡环操作过程中具备降温使用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注谢开水贮罐重要使用双面贮罐此外立式贮罐,满足需要运送泵水量请求,物理学使用罐体风速阻止生态学膜型成。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℃大于保暖循环法装修设计,阻止用热水操作系统微菌物产生和污染问题。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配有带电体空气压缩电加热(空气压缩空气压缩电加热)人工呼吸滤水器。Equipped with electric heating, steam heating) breathing filter◆罐底水流口加设碗形侧板以壮大采拒马河水面,预防电磁。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐是接入主要采用惰性气体爱护,能维持制药企业拿水保存及合理安排整体负压,以免外观流入被污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药业开水运输泵运用316L不锈钢板手工制造(浸水位置),电打磨抛光并钝化治疗。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系統的工艺操作流程图
