Continuous Granulation in the Pharmaceutical Industry

Continuous manufacturing

Continuous manufacturing offers many opportunities to overcome the challenges of traditional batch production of tablets and capsules. The method is efficient and inherently scalable, andscalable and has advanced to a point of true reliability and flexibility. Continuous manufacturing techniques can be implemented all at once, or a little at a time.

The future of oral drug manufacturing

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

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 white paper

Continuous manufacturing system advantages

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. Numerous commercial products are available that are being produced in a continuous process.

Batch processing in the pharmaceutical industry

It can seem daunting to move away from the batch processing, which has served pharmaceutical manufacturers well for so many years. Questions arise when looking at a new process:

Will I lose flexibility for producing multiple products?
How will I characterize the homogeneity of my mix?

Flexibility: There is great flexibility in continuous manufacturing. Switching production from one drug product to another is possible with quick, easy replacement of product contact parts to eliminate the risk of cross-contamination. And modularity allows the granulator to be easily set up for a different product’s required process steps.

Characterizing homogeneity: Online analytical technologies (e.g., near infrared or NIR spectroscopy) allow manufacturers to characterize homogeneity and other material properties at any time in the process. So, the ability to characterize properties is maintained in continuous manufacturing via online analyzers.

Continuous processing in pharmaceutical manufacturing

Quantum leap vs. Slow migration…

Continuous processing in pharmaceutical manufacturing can be used from the mixing of initial powders to the packaging of final tablets. This continuous processing can be done with a twin-screw extruder and subsequent drying in a fluidized bed system.

So, the starting point can be small: a stand-alone twin-screw granulator. If more granules are needed, simply run the instrument continuously for a longer period of timeperiod.

Modules can be added along the way, expanding the parts of the process that operate continuously:

Dosing systems
Dryers
Tablet presses
Etc.

A full continuous system can be grown module by module or be put into place all at once with an entire processing line installation. Such installations often take place by scale-out or scale-up.

Scale-out is possible by creating other small copycat systems in different locations, or simply running the process on one instrument scale for a longer time.

Scale-up is done by transferring the process to high-volume, high-speed production systems.

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), hot-melt extrusion (HME) processes, or for dedicated TSG. Modules expand their use throughout the process from raw materials to tableting.