妙用与简价/Brief Introduction:
皮下填充用纯净水产品皮下填充用纯净水是纯化水经萃取增值税,结核杆菌内毒性等标准均贴合我国药典皮下填充用纯净水项下中规定的污水水质条件,可当糊口物生物制药的企业中各大真接皮下填充入人内抗癫痫药物的石油醚。皮下填充用纯净水产品具体包扩皮下填充用纯净水制作、间歇永久保存、动态信息合理安排和的工艺把控等具体输出模块。
特色/Characteristic:
◆全手动方法行为,以防员误方法受到的生产销售海损;Automatic operation mode, to prevent losses of wrong operation of production;◆部件选择316L材质原料;Components in 316L texture◆带PLC管理的CIP企业产品;CIP products with PLC control◆记录时间与保管难以清理时候的性能参数与环节;Record and save the parameters of the cleaning process and steps◆充分考虑GMP要的可追述性与顾忌明性; Meet GMP requirements traceability and accountability◆内置式化设计的概念可以有效减少区域;Integrated design can effectively save space◆推动制作和净化的迅速的设置;Implement production and clean fast switching◆巴氏室内消毒室内消毒,除污更全面;Babbitt disinfection sterilization, cleaning more thoroughly◆多效减压蒸馏机:该机导压管接连整体使用系统自动悍接,按卫生间级条件,铜阀使用快卡接连,防止出现了打瘦脸针拿水的2次严重污染;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◆纯水汽产生器:PLC组队进行把控好用户界面,可0-100%定时调至必须要的产能标准;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲点设置:打用自来水装置清洁内部管道无法GMP3D让,胶垫为PTPE/EPDM,隔离膜阀平均水平按照时为四十五度,反复地埋管按照设为0.5的相对高度,设低一点为排放口点,同时以湍液状态下反复流量的放置和传输装置,放置微怪物的存在;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◆完好的系統文档文件名系統:①系統文档文件名适合GMP规范要求;②自行化有效控制系統可适合GAMP5;③3Q系統文档文件名必须要满足医药集团厂证实的必须要。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◆添置高的性能定频泵加以输送管和重新分配皮下注射用自来水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板传热器,在纯化水长的时间反复的方式中发挥冷去角色。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆填充使用水进行贮罐先期主要包括落地贮罐其二柜式贮罐,需要满足传输泵低水位规范,科学学如何设置碱罐流动速度放到动物膜养成。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.◆采用了80℃上述隔热保温重复构思,处理用清水体系微分子生物学蔓延和的污染。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆购置带电体加温(空气压缩加温)深吸气过滤装置器。Equipped with electric heating, steam heating) breathing filter◆罐底出水量口加设球形挡片以发展采水底,预防涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐接通用于离氮气守护,保证药业有限公司用热水补充及分派系统正压力,可以防止外观流入环保问题。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆生物制药用水的输送机泵运用316L不锈钢装饰管生产制造(浸水部份),电镜面抛光并钝化除理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、体系制作工艺流量图
