Real-time granulation monitoring
Processes in which smaller particles aggregate to form larger granules (granulation) are among the most widely used processes in the industry. Currently, batch rejects due to granulation process problems can be as high as 20 %. EU-funded scientists launched the project PARTICLE-PRO (Development of a hybrid process analytical technology to characterise the physical and chemical properties of particles) to deliver an in-line platform to characterise physical and chemical granule characteristics which are the critical to quality attributes of granulation processes. Researchers focused on size and shape characteristics, moisture content and active ingredient content uniformity. These properties are currently evaluated off-line in the end-product. Investigators have delivered a hybrid process analytical technology. Combining collimated 3D imaging analysis via the EYECON ® technology of a partner company and novel miniaturised near-infrared (NIR) multipoint or quasi-chemical spectroscopy, the technology provides physical and chemical information and images during the granulation process. The consortium consulted with both project and industry end users to ensure appropriate system specification and application identification. While the research focused on fluid bed granulation (FBG), potential laboratory and industrial applications include spheronisation, fluid bed coating, continuous roller compaction and twin screw wet granulation platforms. The system proved technically capable of monitoring and tracking process changes in real time on both industrial and laboratory scale FBG processes. The key driver here is to improve process understanding and provide scientific data needed to develop much-needed quality control technology for the granulation process. This procedure is critical, not only to pharmaceutical production, but also to sectors such as those related to foods, nutritional supplements and cosmetics. Initially, the team built and evaluated test rigs for the physical imaging and multipoint NIR systems to support development work. In parallel, scientists have designed the industrial prototype, including specifying the components for the NIR module. Leaflets have been produced and circulated to spread the word and generate interest. PARTICLE-PRO technology will enable manufacturers to assess both physical and chemical granule characteristics during the granulation process. Applications feature in areas as far apart as food, fertiliser, fine chemical and pharmaceuticals.
Keywords
Granulation, pharmaceuticals, in-line quality control, PARTICLE-PRO, Process Analytical Technology, EYECON
