PAT system to control physical and chemical properties of particles

Particle-Pro is a project that has been initiated to develop a hybrid process analytical technology to characterise the physical and chemical properties of particles, particularly in the pharmaceutical sector. This sector like any other in the current economic environment has to look at how it positions itself with respect to innovative and robust drug development and how it looks at opportunities to reduce cost. 70% of pharmaceutical drugs are consumed as powders in the form of tablets or capsules. 50 billion aspirin tablets alone are consumed worldwide each year.

As tablets are the most common drug dosage form today, granulation, which allows primary powder particles to adhere and form granules, is one of the most important unit operations in drug manufacturing. Batch rejects that result from process problems can be higher than 20%, the root cause being a lack of process understanding and control. Batch rejects can be a major issue as some APIs can be worth as much as €1million / kg. As products become increasingly complex, understanding pharmaceutical processing is growing more difficult. Regulatory bodies are encouraging the drug lifecycle concept which links product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production.

The FDA guidance document, Process Validation: General Principles and Practices, promotes modern manufacturing principles, process improvement, innovation, and sound science.
Key to better understanding is knowledge, and access to real-time on-line measurements is fundamental. Indeed, the concept of “Process Analytical Technology” (PAT) is the new framework for better understanding in pharmaceutical processes of which granulation is a very big part. Central to PAT is improving final product quality by process design through knowledge of the fundamental scientific principles behind it, and continuous online control of a process.

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