Quality by Design (QbD) consists of rapidly changing process and product development methods used throughout the pharmaceutical industry. QbD studies require the highest quality of experimental equipment and Process Analytical Technology (PAT) to ensure an accurate determination of process variability and maximum confidence in the proposed design space. Quality by Design (QbD) requires experimental equipment and measurement technology of the highest quality. Design space mapping is a wasted effort if variability in the experimental conditions or poor analytical results limits conclusion reliability. The control of critical variables (such as initial reactant concentrations, addition rates, pH, temperature, pressure and agitation rates) is virtually impossible using traditional manual methods employing round-bottomed flasks with ice/oil baths.
Data-rich experimentation and improved control of Critical Process Parameters (CPPs) are two important aspects of improving the overall productivity and quality of results from DoE (Design of Experiments) testing. Additionally, PAT and data rich experiments can certainly enable the process design specialist to understand specific processes and be able to reach an optimized process faster – reducing the amount of time and resources spent on developing each process. This can be especially important during a project or technology transfer between sites or companies. Follow-on benefits to the improved research and development capabilities are simply those of better process design, i.e. more reproducible production, better product quality and better resource utilization by eliminating bottlenecks in the pilot plant or production facility. Ultimately this should all lead to less waste, higher productivity and higher profits.
METTLER TOLEDO offers a wide range of laboratory and production (plant) PAT tools that have been used effectively for more than 20 years. They can provide insights into best practices in the pharmaceutical industry based on applying QbD principles with the use of the highest quality automated reactors and Process Analytical Technology (PAT).