‘Extending the boundaries of QbD’, a new whitepaper from Malvern Instruments, explores the application of Quality by Design (QbD) principles to the development of analytical instrumentation and the benefits this brings for users.

Taking the example of Malvern’s development of the Mastersizer 3000 particle size analyzer, the authors illustrate how instrument companies are aligning with the QbD philosophy. This offers pharmaceutical customers the reassurance of closely similar working practices and products that meet exacting customer standards.

The central idea of QbD is that quality should be built into a product from the outset. It is an approach based on the development of a thorough understanding of the variables that impact performance, quantification of the risks associated with those impacts, and knowledge-based risk mitigation. Taking a similar risk assessment-based QbD approach to instrument design builds consistency and performance into a product from the outset. This thought and knowledge translates directly into an analytical tool that is not only reliable and compliant with regulatory requirements but is also efficient, productive and easy to use.

The starting point for QbD is the clear definition of a target performance profile for the product. The design of the Mastersizer 3000 began with a rigorous assessment of industrial requirements for particle size analysis and, since the product is wrapped by a cycle of continuous improvement, that assessment continues today. The third anniversary of the instrument has been marked with the launch of two new products that deliver even smarter particle sizing. Hydro Sight is a state-of-the-art imaging accessory that makes it quicker and easier to develop and apply the robust particle sizing methods that are essential across industry, by delivering real-time visual monitoring of the dispersion process that precedes every laser diffraction particle size measurement. Hydro SV is a wet dispersion accessory that enables measurement with just a few milligrams of sample.

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