通用电气医疗集团(GE Healthcare)推出了KTAready液相色谱系统,专门设计用于药物开发I期到III期的流程扩展和生产,以及GLP和cGMP标准的全规模生产。系统操作的简化和产品批次之间停工期的缩短节省了启动时间以及人工及消耗品的花费,改善了成本效率和生产力。
AKTAready以即用型一次性流程进行操作,排除了交叉污染的风险,以及清洁和对清洁程序进行验证的需要。
AKTAready包括色谱柱、UNICORN软件以及含有传感器和检测流动室的ReadyToProcess Flow试剂盒。UNICORN带有安装向导,提供了色谱柱安装的操作指南和报告,确保试剂盒的正常工作。所有的?KTA系统使用了相同的软件,能够轻松实现流程的扩展和完整cGMP生产中AKTAprocess的快速转换。
AKTAready系统由大量的产品监控文档和服务提供支持,具体包括验证文档、有关使用材料信息的产品文档、美国药典第六类CFR 177和AOF证书,以及监控支持文件(RSF)。
AKTAready是通用电气医疗集团ReadyToProcess整体解决方案中的一部分,此方案能协助提高生物制药的生产效率。ReadyToProcess通过消除上游及下游处理的日常工作中的浪费行为,实现精益生产。产品包括WAVE生物反应器、WAVE混匀器,和一次性的CellBag,色谱柱以及普通的流动盖和ReadyMate一次性的无菌连接管。ReadyToProcess产品线提供了最大的灵活性,简化并加速了生物处理,专为从发酵到纯化的升级和顺利操作而设计。
ÄKTA™ ready system
Disposable flow path allowing fast changeover and flexibility.
ÄKTA ready is a liquid chromatography system built for process scale-up and production for early clinical phases.
The system operates with ready-to-use, disposable flow paths and as a consequence, cleaning between products/batches and validation of cleaning procedures is not required.
System meets GLP and cGMP requirements for Phase I-III in drug development and full-scale production
Improved economy and productivity due to simpler procedures
Single-use eliminates risk of cross-contamination between products/ batches
Easy connection to and operation with prepacked ReadyToProcess™ columns and other process columns
Scalable processes using UNICORN™ software
ÄKTA ready is a part of the ReadyToProcess platform, consisting of plug and play, ready-to-use solutions for entire processes.
| Width / Depth / Height | 1000/800/1650 mm |
| Weight | 230 kg |
| Control system | UNICORN™ version 5.11 or higher |
| Instrument input voltage | AC Voltage, 1 × 100/120/200–208/220–230/240 V, ± 10%, 50/60 Hz |
| Max. power consumption | 1 kVA |
| Ingress protection | IP45 |
| Compressed air interface | 5.5–7 bar, 50 Nl/min, oil- and particle-free |
| Operating temperature | 2°C–30°C |
| Volumetric flow rates | 7.5–510 l/h High Flow Kit 3–175 l/h Low Flow Kit |
| Max. pressure, peristaltic pump | 4.0 bar |
| System pressure rating | 5.0 bar (high-pressure flow path, upstream column) 2.0 bar (high-pressure flow path, downstream column) 0.95 bar (low-pressure outlet manifold) 0.6 bar (low-pressure inlet manifold) |
ÄKTA ready is a liquid chromatography system built for process scale-up and production for early clinical phases. It ispart of the ReadyToProcess platform, a suite of plug and play, ready-to-use solutions for bioprocessing. The systemoperates with ready-to-use, disposable flow paths that are available separately in High and Low Flow Kits. As a benefit, the need for cleaning between products/batches is eliminated and no development and validation of cleaning procedures is required. Replacing flow paths between projects is fast, and when used together with ReadyToProcess™ columns, the risk for crosscontamination is removed.
ÄKTA ready system系统资料下载ÄKTA ready system
超灵活ÄKTAready自动工业层析系统:从中试到规模放大






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