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锐拓RT600-AT 8杯自动取样溶出系统
锐拓RT600-AT 8杯自动取样溶出系统包括:锐拓RT600 溶出度仪 和 锐拓溶出自动取样工作站。
锐拓RT600溶出度仪是按照《中国药典》和《美国药典》以及《药物溶出度仪机械验证指导原则》要求而全新设计制造的高性能的8杯8杆溶出度试验装置。其机械参数精准,性能稳定,且拥有*符合数据完整性的操作系统,适用于各种标准化的溶出测试。
锐拓溶出自动取样工作站配备8通道或12通道高精度锐拓注射泵或柱塞泵(二者选一),兼任桨法、篮法和小杯法,能有效地在每个时间点提供精确的自动取样,体现高效、准确、稳定、软件易用等优势。
自动同步投药
▶标配自动投药模块,可以实现所有样品自动同步投药,投药时间点可以被系统记录和审计追踪。
▶投药后,取样时间自动计时,到达取样时间点前,会有提示鸣响。
灵活精准的取样方式
▶取样位置自动定位:系统将根据溶出测试预设的实验方法(篮法/桨法等)和溶出介质体积,自动定位取样针的取样位置。
▶非驻留式取样针,减少测试过程中溶出介质扰流的产生。
▶灵活的取样方式,支持自动取样和手动取样。
▶自动取样:另外配置自动取样工作站的情况下,可以通过自动取样工作站在预设的取样时间点进行自动取样。
▶手动取样:可以通过防蒸发盖上预留的取样口进行手动取样,或使用自动定位取样针进行手动取样。
桨篮共轴分体式设计
▶篮法、桨法、小杯法的溶出搅拌部件均采取共轴分体式设计。
▶篮法/桨法等溶出搅拌部件可以在同一个转轴上自由切换,无需重新定位,准确方便,大量节省实验时间。
▶溶出搅拌部件与转轴连接处位于溶出介质液面上方,便于清洁,无残留风险。
▶溶出搅拌部件材质均为316L不锈钢,并有特殊防腐蚀镀膜处理,有效应对各种实验条件。
溶出杯包覆式设计
▶锐拓溶出杯的杯口边缘采用创新包覆式设计,有效避免了溶出杯在使用过程中可能出现的磕碰损伤,使溶出杯更加经久耐用。
▶快捷准确的溶出杯安装:将溶出杯的三个凸扣对准安装平台底座孔位的三个凹位,放入溶出杯,顺时针方向旋转30°,即可完成安装。
▶淘汰传统的溶出杯固定弹簧卡扣,一体化平整的溶出杯安装平台十分方便清洁。
先进的机械部件设计
▶驱动头采用智能自动升降方式:溶出仪驱动机头精准可靠地升降,确保搅拌轴高度、中心位置等关键实验参数拥有*的准确度和重现性。
▶高清晰度8寸宽面触摸屏,清晰呈现实验流程和测试参数,方便操作。
▶非驻留式温度探针,在每个预设的取样时点监控溶出介质的温度。
▶水浴槽采用一体成型圆角设计:水浴循环*,恒温能力优;无清洁死角,水浴排水口位于水浴槽底部,可以保证水浴可以*排干。
自动取样工作站
▶自动取样点多可设置20次,大取样量可达20ml,满足所有的溶出需求。
▶采用高化学稳定性、高抗吸附的Teflon取样管路,避免取样管路腐蚀或吸附。
▶取样前润洗取样管路和回路,样品浓度更加精准。
▶取样后,将取样管路、回路、注样针管路的残留液体吹扫排空,取样体积更加准确。
▶可以加装二级在线过滤器(如0.45μm等尺寸的盘状滤头),仪器可以自动实现二级在线过滤。
▶拥有自动回补溶媒和自动清洗管路的功能。
*符合数据完整性的操作系统
▶软件系统:软件系统操作简单,容易上手;可以存储至少500种溶出实验方法;系统存储量可以满足至少10年的记录存储。
▶用户权限管理:可以预设至少100个登陆账号,用户登陆密码保护;可以分配至少3种用户权限(系统管理员,实验室主管,实验分析人员);可以由用户根据自身风险评估,灵活地自定义各种权限等级的权限细则。
▶审计追踪:各个层面具体到单独账号的审计追踪功能,包括登陆记录、实验记录、操作记录、清洁记录等。
▶电子数据完整性:实验时能够同步生成准确的电子数据,每个实验都会自动生成对应的实验记录,并支持PDF格式导出;实验记录和系统所有记录均可以被检索、导出、备份和打印;所有电子数据均受到保护,避免被随意篡改和删除。