的用途与概况/Brief Introduction:
填充需要自来水生产设配填充需要自来水是纯化水经水蒸气蒸馏所得税率,微生物内黑色素等依据均非常符合全球药典填充需要自来水项下法律法规的水的质量必须,可当过活物制药厂工业企业中几大类单独填充入人内药品的相转移催化剂。填充需要自来水生产设配通常比如填充需要自来水制取、循环往复贮存、动图合理安排和工艺流程把握等通常功能。
性能/Characteristic:
◆全自行工作原则,可以防止师误工作受到的工作毁损;Automatic operation mode, to prevent losses of wrong operation of production;◆部位按照316L原材料;Components in 316L texture◆带PLC调控的CIP物品;CIP products with PLC control◆记录卡与手机截图洁净全过程的性能与环节;Record and save the parameters of the cleaning process and steps◆具备GMP规定要求的可产品追溯性与可说是明性; Meet GMP requirements traceability and accountability◆生活化装修设计有没有效节约使用空間;Integrated design can effectively save space◆保证 生产销售和洁面的飞速调节;Implement production and clean fast switching◆巴氏酒精消毒灭菌,擦拭更彻底解决;Babbitt disinfection sterilization, cleaning more thoroughly◆多效减压蒸馏机:整个机械管道连入所有的主要所采用自動焊接加工,按食品卫生级原则,铜阀主要所采用快卡连入,禁止了注入冲水的2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◆纯液体时有产生器:PLC组队使用的控制程序界面,可0-100%主动调接至要的生产产量条件;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无㓟盲区的设计:打针需要用水控制系统化干净导压管实现GMP3D的标准,胶垫为PTPE/EPDM,隔离膜阀技术按装时为四十五度,配置地埋管按装设为0.5的坡度比,设低些为废气点,同时以湍液心态配置流动量的放置和气力输送机控制系统化,阻止细小微生物体的形成;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◆完正的资料整体:①资料按照GMP条件;②手动化的控制整体可按照GAMP5;③3Q资料满意制作药品厂校验的须要。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◆选用高特点直流变频泵什么的工具气流输送和重新分配针剂用纯净水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热换器器,在纯化水长时长再循环流程中发挥放凉功用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注谢清水贮罐最优采用了立柱式贮罐第二步卧试贮罐,满足了传输泵地下水位标准,学科软件设置罐里空气流速防范微生物膜确立。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.◆通过80℃不低于隔温配置设置,必免开水系统性生物学大量滋生和影响。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆标准配备有电加水(压缩空气加水)吸呼吸附器。Equipped with electric heating, steam heating) breathing filter◆罐底冒水口镇加设锥型侧板以增大采池底,杜绝涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐接通选取惰性气体保护的,能维持化工水保管及合理安排设计压缩空气,以免外边出液污染源。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆药业用清水运输泵采用了316L铝合金打造(浸水地方),电增加光泽并钝化治理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、程序方法过程图
