应用领域与简单介绍/Brief Introduction:
注塑冲水的设施注塑冲水的是纯化水经水蒸气蒸馏得到,微生物内毒性等标准均符合标准我们药典注塑冲水的项下相关规定的水质监测规定,可当养家糊口物化工企业主中当下可以注塑入人体细胞内药材的有机溶剂。注塑冲水的设施通常属于注塑冲水的分离纯化、反复的储藏、动态性分发和工序操作等通常功能模块。
特质/Characteristic:
◆全手动实操行为,防范师误实操引致的产量损毁;Automatic operation mode, to prevent losses of wrong operation of production;◆结构件按照316L质量;Components in 316L texture◆带PLC把控好的CIP的产品;CIP products with PLC control◆见证与存放拆洗具体工作步骤的参数值与工作步骤;Record and save the parameters of the cleaning process and steps◆做到GMP让的可溯源性与可聊明性; Meet GMP requirements traceability and accountability◆整体化设计的有没有效节约环境空间;Integrated design can effectively save space◆变现分娩和除污的快捷开启;Implement production and clean fast switching◆巴氏酒精消毒除臭,擦洗更充分;Babbitt disinfection sterilization, cleaning more thoroughly◆多效萃取机:一整台机器的滤油器衔接其他所采用了自动式悍接,按环境卫生级标准的,调节阀 所采用了快卡衔接,防止了注射液体用纯净水的再次生态破坏;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◆纯水蒸气情况器:PLC人与机器的操作的控制接口,可0-100%智能设定至需求的生产量标准要求;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无卫生死角结构设计:注入使用水进行平台的整洁导压管规范GMP3D规范,胶垫为PTPE/EPDM,膈膜阀平行按装时为50度,重复线管按装设为0.5的道路倾斜度,设低开为减排点,并且以湍液方式重复进出的低温干燥和输送管平台的,阻止微动物的蔓延;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◆详细的文档程序资料调节整体:①文档程序资料遵循GMP让;②自動化调节调节整体可遵循GAMP5;③3Q文档程序资料需求药厂厂安全验证的需求。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◆合理配置高功效交流变频泵加以气流输送和都分配好皮下注射用清水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器,在纯化水长日期间歇全过程中达成水冷却角色。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆肌注用热水贮罐择优应用立试贮罐而后立式贮罐,让传送泵潮位让,物理学布置罐里水流量预防海洋生物膜生成。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℃这些保温隔热再循环规划,解决办法污水平台微生物发酵学滋长和环境破坏。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆合理配置感应起电微波采暖器(过热蒸汽微波采暖器)喘气进行过滤装置。Equipped with electric heating, steam heating) breathing filter◆罐底冒水部位加设椎型挡条以提高采出水面,以免涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐联接使用离氮气保护区,形成制药业用热水保管及分销控制系统送风机,以免外部链接流回的污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药企业加水气流输送泵用于316L不锈钢装饰管吗制造厂(浸水局部),电磨光并钝化补救。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、整体工艺设计程序图
