Applying a QbD approach to instrument design identified the need for a wider particle size measurement range, which was achieved through the smart Mastersizer 3000 optical design.

‘Extending the boundaries of QbD’, a new whitepaper explores the application of Quality by Design (QbD) principles to the development of analytical instrumentation and its benefits.

Through the example of the Mastersizer 3000 particle size analyzer, the authors illustrate how companies specialising in instruments align with QbD philosophy.

Pharmaceutical customers are offered the reassurance of closely similar working practices and products that meet specific 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.

A risk assessment based QbD approach to instrument design builds consistency and performance into a product from the outset. This knowledge translates directly into an analytical tool that is reliable, compliant with regulatory requirements, and also efficient, productive and easy to use.

The starting point for QbD is the clear definition of a target performance profile for the product. Designing the Mastersizer 3000 began with a rigorous and continuous assessment of industrial requirements for particle size analysis, since the product is continuously improved.

The third anniversary of Mastersizer 3000 was marked with the launch of two new products that deliver smarter particle sizing.

Hydro Sight is a state-of-the-art imaging accessory, which makes it quicker and easier to develop and apply robust particle sizing methods, 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 from just a few milligrams of sample.