领域与百科/Brief Introduction:
肌注饮开水专用机肌注饮开水是纯化水经分馏偶然所得,菌内内毒素等指数均贴合我国的药典肌注饮开水项下指定的水质量标准,可当为业物医药企业中各样一直肌注入人内口服药物的有机溶剂。肌注饮开水专用机注意是指肌注饮开水制作、无限循环储藏、静态配资和工艺技术操作等注意控制模块。
优势特点/Characteristic:
◆手动式式运营行为,可以防止人员管理误运营引致的生产方式亏损;Automatic operation mode, to prevent losses of wrong operation of production;◆部分所采用316L不锈钢材质;Components in 316L texture◆带PLC有效控制的CIP类产品;CIP products with PLC control◆纪要与保存图片清洁工作的过程 的叁数与工作步骤;Record and save the parameters of the cleaning process and steps◆考虑GMP耍求的可最早能性与可以说明性; Meet GMP requirements traceability and accountability◆一体式化规划可以效节约开支个人空间;Integrated design can effectively save space◆推动生孩子和清洁卫生的快修改;Implement production and clean fast switching◆巴氏清洁消菌,刷洗更全面;Babbitt disinfection sterilization, cleaning more thoroughly◆多效水蒸气蒸馏机:主机压缩空气管连到大部分进行自行悍接,按环卫级标准单位,管道阀门进行快卡连到,防范了注塑用热水的重新弄脏;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◆纯蒸汽式遭受器:PLC组队运作设定页面,可0-100%会自动调低至标准的出现标准;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无方位构思:针剂使用水进行操作系统化洁净度线路充分满足GMP3D标准要求,胶垫为PTPE/EPDM,隔离膜阀水准装有时为90度,嵌套嵌套循环地埋管装有设为0.5的道路倾斜度,设底点为排放物点,并用湍液情况嵌套嵌套循环还是流动性的储存室和输送管操作系统化,可以防止微生态学的泛滥;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◆完成的文档程序目录机体统:①文档程序目录考虑GMP不符合要求;②半智能化设定机体统可考虑GAMP5;③3Q文档程序目录考虑生物农药厂印证的必须。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◆配置高效果变频柜泵从而输送机和分派针剂纯净水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热交换器,在纯化水长用时反复的步骤中具有保压功用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆针剂用清水贮罐重要适用直列V型贮罐后者立式贮罐,需要满足运送泵水位线的标准,生态学学设备罐中风速制止生态学膜演变成。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.◆用于80℃超过保冷再循环设计的概念,以防纯净水设计微微生物检测产生和环境污染。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配用通电的受热(蒸汽发生器受热)气息筛选器。Equipped with electric heating, steam heating) breathing filter◆罐底冒水口镇加设锥型挡条以前所未有采河面,可以防止涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐联接主要包括N2保护性,保持生物制药使用水保存及调整程序 压,以防止静态流失感染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制作药品拿水输送带泵主要包括316L304不绣钢研发(浸水环节),电抛光治理 并钝化治理 。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、整体工艺过程过程图
