的主要用途与详细介绍/Brief Introduction:
填充清水机械的设备填充清水是纯化水经分馏个人所得,真菌内内毒素等招生指标均复合中国人药典填充清水项下归定的水体请求,用做糊口物药厂企业中各种单独填充入人体细胞内制剂的容剂。填充清水机械的设备主耍比如填充清水制取、循环系统补充、最新分销和工艺设计的控制等主耍功能。
特质/Characteristic:
◆全主动实际操作的原则,控制员工误实际操作的受到的生產亏损;Automatic operation mode, to prevent losses of wrong operation of production;◆配件主要采用316L才质;Components in 316L texture◆带PLC管理的CIP商品;CIP products with PLC control◆记录时间与存为擦拭进程的技术参数与步数;Record and save the parameters of the cleaning process and steps◆充分考虑GMP规定的可溯源性与可聊明性; Meet GMP requirements traceability and accountability◆整体化装修设计还有效节省了发展空间;Integrated design can effectively save space◆控制加工和清理的尽快设置;Implement production and clean fast switching◆巴氏清理杀菌消毒,清理更齐全;Babbitt disinfection sterilization, cleaning more thoroughly◆多效水蒸气蒸馏机:整套装置压缩空气管相连都选择会自动焊接生产,按环卫级标准单位,阀体选择快卡相连,避免出现了打瘦脸针供水的四次环境破坏;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◆纯饱和蒸汽突发器:PLC人与机器管控管控软件界面,可0-100%会自动调整至要有的收获量规定要求;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲区设计方案:肌注使用水进行模式洁净室滤油器达到GMP3D追求,胶垫为PTPE/EPDM,pu气管阀的水平施工时为四十五度,巡环输油管线施工设为0.5的道路倾斜度,设低些为排卸点,仅以湍液环境巡环流失的存贮和运输模式,阻止微海洋生物的滋生腐败;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◆删改的文书程序:①文书要求GMP条件;②自然化管理程序可要求GAMP5;③3Q文书要求生物药业公司查证的必须要 。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◆购置高特性交流变频泵用来输送管和重新分配注射器用清水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板传热器,在纯化水较长时间段再循环的过程中体现了蒸发效果。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注谢需要用水贮罐为先利用落地贮罐另一方面离心式贮罐,足够运输泵水位线的要求,实验设计罐里流体密度预防微生物膜组成。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.◆采取80℃这些隔热反复的制作,以防止拿水模式微动物繁衍和破坏。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆具备导电加温(蒸汽高温加温)气息过滤程序器。Equipped with electric heating, steam heating) breathing filter◆罐底有水出口加设椎型侧板以拓展采冰面,预防电磁感应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐接通采用了氦气爱护,确保制药厂用纯净水店铺及分销整体送风机,避免 其他流失被污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药厂自来水卸料泵主要采用316L不锈钢304制作(浸水组成部分),电磨光并钝化办理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系统软件工艺设计方案图
