Continuous granulation

Gain the advantages of a continuous process

利用连续工艺的优势

连续造粒为片剂和胶囊的生产提供更加高效、廉价的途径,特别是在新剂型开发中,因批次装置(如混炼机、搅拌器和切碎机)中的最佳工作点较窄而导致大规模生产难以实现时。

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The future of oral drug manufacturing

Most oral drugs are available as tablets and capsules because it’s easy to store and consume medicine in this form. Traditionally pharmaceutical manufacturers have created such oral dosage forms in batches. Now, many are considering a continuous manufacturing process. Why? How?


Why continuous granulation?
Continuous granulation

Small, medium and large batches of pharmaceuticals are prone to variations and expensive delays:

  • Manual steps invite human error
  • Transportation from one step to the next may cause material segregation
  • Time-consuming disassembly and cleaning delay production
  • Production scale-up requires bigger, more expensive equipment

Continuous manufacturing reduces/eliminates the issues above and makes subsequent tableting easier. With online monitoring, continuous manufacturing also enables drugs to be released as soon as they’re manufactured – there’s no waiting on analytical results before products can ship.

Today, continuous manufacturing is no longer an “untested” process. Companies have gained experience and proven that it can be successfully implemented with a significant positive impact.

TSE for mixing and granulation

Set up continuous manufacturing so it really works!

Establishing a successful continuous twin-screw granulation (TSG) process can be tricky. Download this free whitepaper with expert advice for process design, development and scale-up for pharmaceuticals. The paper even includes information about how the parameters of twin-screw extruders can impact scale-up of a continuous process.

Download whitepaper

为何采用连续造粒

传统上,在制药生产中,单独工艺步骤往往分批执行,造粒便是如此。原料经过造粒和团聚,保持均匀的粒度分布。物理性质的改变(如更好的流动特性、可压缩性、低粉尘沉积和优化的活性成分释放曲线)有利于后续压片过程。

使用双螺杆挤出机,再采用流化床系统进行干燥,实现从起始粉末混合到最终片剂包装的连续工艺。

连续工艺好处颇多。使用占地面积小的小型设备,轻松控制整个过程。由于物料用量少,该过程可实现批量尺寸的高度灵活,改善控制和一致性。连续工艺省去分配步骤,降低原料称量和处理过程中操作员失误的风险。

由于整个过程采用模块化设计,关键工艺步骤较易扩大,方便从开发(约1 kg/h)到规模生产(约 300 kg/h)的设施设置。

Thermo Scientific pharmaceutical twin-screw extruders are designed to bring you the benefits of continuous manufacturing – whatever your pace may be.

We offer 11 mm, 16 mm and 24 mm pharmaceutical extruders that can stand alone or be partially or fully integrated into your manufacturing process. Systems are available for dual twin-screw granulation (TSG) or hot melt extrusion (HME) processes, or for dedicated TSG. Modules expand their use throughout the process from raw materials to tableting.

Featured video

Walk though of the conversion from hot melt extrusion to twin-screw granulation on the Pharma 16 Twin-screw extruder.

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