功能与简单介绍/Brief Introduction:
皮下接种纯净水装备皮下接种纯净水是纯化水经减压蒸馏所得税,细菌和病毒内毒性等招生指标均满足中国人药典皮下接种纯净水项下约定的地表水标准,可以作为养家糊口物医药化工制造业企业中各马上皮下接种入躯干内用药的溶液。皮下接种纯净水装备重要包涵皮下接种纯净水分离纯化、不断循环处理、日常动态分销和的工艺操作等重要功能模块。
共同点/Characteristic:
◆全自己运作方式英文,阻止师误运作提供的制作毁损;Automatic operation mode, to prevent losses of wrong operation of production;◆机件选取316L材料做;Components in 316L texture◆带PLC把握的CIP护肤品;CIP products with PLC control◆数据与保管洗掉步骤之一的参数指标与步骤之一;Record and save the parameters of the cleaning process and steps◆提供GMP让的可追朔性与顾忌明性; Meet GMP requirements traceability and accountability◆内置式化设计制作可以有效合理利用环境;Integrated design can effectively save space◆确保生孩子和环保的迅速调节;Implement production and clean fast switching◆巴氏清洁杀菌的,清洁更全面;Babbitt disinfection sterilization, cleaning more thoroughly◆多效水蒸气蒸馏机:组装机管道止回阀接都是运用智能点焊,按卫生间级规则,止回阀运用快卡接,防范了针剂冲水的二级环保问题;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◆纯蒸汽会检测器会检测器:PLC电脑操作的操控用户界面,可0-100%半自动调试至须得的生产产量标准要求;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无方位来设计:针剂需要用水模式干净聚氨酯保温管无法GMP3D规范要求,胶垫为PTPE/EPDM,隔离膜阀技术装置时为90度,不断反复污水管装置设为0.5的坡度比,设低些为排放标准点,后以湍液工作状态不断反复流动量的存储和气流输送模式,处理的微生物学的大量滋生;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◆全版的资料设备:①资料具有GMP规范;②半自动化管理设备可具有GAMP5;③3Q资料提供化工厂效验的还要。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◆标准配置高功能变頻泵借以传送和分摊肌注用热水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热交换器,在纯化水长耗时循坏具体步骤中有着待冷却功用。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆肌内注射用纯净水贮罐择优用卧试贮罐一方面卧试贮罐,需要满足推送泵地下水位让,小学科学設置罐中流动速度以免生物制品膜达成。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.◆主要采用80℃左右隔温循坏设计的,可以防止清水整体微动物生长和污染问题。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配置有电煮沸(过热蒸汽煮沸)吸气过滤器。Equipped with electric heating, steam heating) breathing filter◆罐底出水出水部位加设碗形侧板以增加采拒马河水面,控制涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐连接按照离氮气护理,保持化工使用水进行永久保存及平均分配机系统送风机,处理外面离交柱水污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆医药化工水运送泵使用316L铝合金制作(浸水有些),电打磨并钝化正确处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、模式新工艺具体操作流程
