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In this short presentation, Des OGrady introduces some of the fundamental challenges associated with designing particle processes. Some fundamental needs will be identified and potential solutions to key challenges proposed.

Particles play a role in many products. For example the active ingredient in a medicine is often composed of highly pure, microscopic particles. Particles can be problematic to manufacture because attributes such as size and shape can influence processability causing major bottlenecks.

One common way to create particles is through crystallization – a highly efficient process that can isolate and purify a product simultaneously. However obtaining the correct particle size and shape consistently form a crystallizer can be challenging. Poor performance in the crystallizer can lead to significant challenges downstream during further processing. By developing high quality crystallization processes – it is possible to design fit-for-purpose particles that simplify downstream performance.

Every enterprise has requirements to reduce costs, get to market faster and meet tightening regulatory demands. Particle processes can hamper efforts to make improvements in these areas – and often cause slowdowns in development or cost increases in manufacturing that can be crippling.

Particle processes pose challenges that are unique – and unlike those encountered in gaseous or liquid systems.

One way to look at the particle engineering – and any effort to design particles with the correct attributes – is to consider the relationship between the process parameters chosen and the final results. During particle formation particles undergo many different potential transformations that are influenced by different process parameters. Scientists have an array of process parameters they can choose from in order to create the particles they need.. Understanding how parameters influence transformations – and how the transformations influence the final particle properties is critical.

Historically offline tools have been used for particle characterization. Many different techniques are available and they have become the de facto standard for setting specifications and ensuring particles meet the desired level of quality. In order to obtain a useful particle size measurement from an offline analyzer careful method development is required and particular attention must be given to how samples are obtained and prepared prior to analysis.

Complementary tools are available that support enhanced particle engineering. Process parameters should always be recorded and controlled with precision. And in situ analysis of solid and liquid phases provides the process understanding needed to attack complex particle design problems.

Using offline analysis alone can prolong development time by failing clearly understand how process parameters influence the critical transformations that occur during particle formation.

However by combing offline quality control tools – with a particle engineering toolbox – scientists can obtain complete understanding enabling improved optimization and control.

This approach has significant benefits for scientists.
1. Improve Process Understanding
2. Use data to solve problems
3. Improve safety and productivity

A common particle engineering toolbox includes a reactor that mimics conditions at larger scales as well as probe based tools that provide immediate understanding for the particle system. Software should tie all of this information together seamlessly allowing scientists to concentrate exclusively on using the data to make excellent evidence-based decisions.

The particle engineering toolbox has real strategic benefits for companies:

1. Particles with the desired attributes can be designed proactively for every project

2.The root cause of problematic processes can be identified quickly – ane evidence can be obtained to support process improvement

3. Demonstrating to regulators that processes are understood and can be controlled is vital. Doing so facilitates regulatory acceptance in a shorter timeframe.

4. Data collected in the lab and plant – can help build confidence across the teams who are tasked with transferring and manufacturing products reliably.

The Particle Engineering Toolbox approach is not new – and has been used extensively for many years to enhance the delivery of high quality particle-based products to the world. Hundreds of references and citations are available.

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