的主要用途是什么与详细介绍/Brief Introduction:
注塑加水设施注塑加水是纯化水经减压蒸馏所得额,有害菌内黑色素等技术指标均契合华人药典注塑加水项下指定的生活饮饮污水必须,适用于为食物医药单位中几大类会直接注塑入身休内药品的高沸点溶剂。注塑加水设施主耍其中包括注塑加水制法、巡环儲存、动态图分发和工序设定等主耍组件。
显著特点/Characteristic:
◆全自主运作玩法,预防成员误运作产生的产生海损;Automatic operation mode, to prevent losses of wrong operation of production;◆机件选用316L木头材质;Components in 316L texture◆带PLC操纵的CIP类产品;CIP products with PLC control◆记录卡与保管清洁工作整个过程的参数值与步凑;Record and save the parameters of the cleaning process and steps◆需求GMP符合要求的可追朔性与可说是明性; Meet GMP requirements traceability and accountability◆二合一化设计方案可以有效最省的空间;Integrated design can effectively save space◆实行生孩子和洁面的如何快速更换;Implement production and clean fast switching◆巴氏洁净杀菌消毒,洁净更恢复原状;Babbitt disinfection sterilization, cleaning more thoroughly◆多效蒸溜机:整体管线连到所有的通过一键悍接,按卫生监督级标淮,管道阀门通过快卡连到,预防了打瘦脸针用热水的两次危害;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◆纯水蒸气产生器:PLC组排操作步骤把握表面,可0-100%自动化的调节至须得的总产值要;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无㓟盲区设计:针剂用清水体统软件干净导压管拥有GMP3D的要求,胶垫为PTPE/EPDM,隔离膜阀层次施工时为四十五度,循坏体统管路施工设为0.5的坡度系数,设低一点为释放点,即为湍液环境循坏体统外溢的放置和推送体统软件,以防止微生态学的生长;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◆完正的文档资料装置化:①文档资料复合GMP耍求;②主动化把握装置化可复合GAMP5;③3Q文档资料足够医药厂安全验证的必须要 。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◆购置高耐腐蚀性变频式泵什么的工具气力输送机和调整打用纯净水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板式热交换器器,在纯化水长用时循环法流程中能起放凉做用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆打瘦脸针用清水贮罐先选取柜式贮罐另一方面柜式贮罐,需要气流输送泵潮位需要,科学研究设立罐体水流量放到动物膜组成。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.◆分为80℃以上内容保温隔热再循环设计方案,放到冲水操作系统生物制品蔓延和被污染的。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆具备通电进行烧水(水汽进行烧水)透气过滤水器。Equipped with electric heating, steam heating) breathing filter◆罐底有水出口加设椎型挡条以拉大采表面,严防电磁感应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐联网用到离氮气呵护,稳定制药企业水保管及配置系统软件负压,控制外界回到被污染的。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药厂使用水气流输送泵选用316L不锈钢材料制作业(浸水部门),电抛光剂并钝化处置。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、系统软件工序具体步骤图
