Moving the lab to the line

Process Analytical Technology (PAT) is a system for designing and controlling manufacturing through the measurement of critical quality and performance attributes during processing to ensure final product quality. Manufacturing is monitored online, inline or atline, resulting in a reduction of production cycle time, minimisation of rejects and reprocessing and real-time release of products from the processing line.

Initially developed for the pharmaceutical industry, the system has applications for all manufacturing.

PAT is one of the objectives contained in the Initiative for Pharmaceutical CGMPs for the 21st Century published by the US Food and Drug Administration. According to the FDA’s guideline, PAT can be defined as a system for designing, analysing and controlling pharmaceutical manufacturing through the measurement of critical quality and performance parameters.

The measurements performed on raw and and in-process materials or process parameters are intended to enhance final product quality. Process analytical technology encourages technological innovation, specifically the adoption of new analytical techniques designed to improve the understanding and control of manufacturing processes. Both the FDA and industry experts expect benefits over conventional manufacturing practices: higher final product quality, increased production efficiency, decreased operating costs, better process capacity and fewer rejects.

PAT methodologies have to be highly automated and the systems have to be reliable, rugged, safe, largely maintenance free and easy to operate.

PAT already plays an important role in the production of biodiesel. The fuel is affected by an aging process, and the quality of each batch has to be verified prior to processing. Too much water can damage diesel motors and cause corrosion. Glycerine, which is a co-product in biodiesel production, can lead to accumulation of carbon deposits in fuel injection systems.

To ensure that engines run properly, producers of biodiesel have to guarantee that certain limits for water, total glycerine and methanol are not exceeded. If this is not the case, the entire process can become contaminated.

Spectroscopic techniques such as near infrared spectroscopy (NIR) are replacing conventional fuel quality control methods, because NIR can quickly detect multiple constituents in parallel. Highly sensitive EP(encoded photometric)-NIR spectroscopy supports high sample throughput and real-time quality control. It is fast, user friendly and economical.

With PAT, there will be a shift from lab-based, end-product quality testing to better formulation and process design leading potentially to more inline, online, or atline testing.

Process analytical chemistry (PAC) generally describes the science and technology associated with displacement of laboratory-based measurements with sensors and instrumentation positioned closer to the site of operation. Although industrial process analysers have been in use for more than 60 years, the modern period of PAC essentially began with the formation of the Centre for Process Analytical Chemistry (CPAC) in 1984. The goal of PAC is to “supply quantitative and qualitative information about a chemical process” for monitoring, control, and optimisation.

The industrial PAC movement has been bolstered by two decades of advances in materials science, electronics, and chemo metrics. Since the inception of CPAC, the pace of innovation in sensors, instrumentation and analytics has quickened dramatically. The development of more robust, sensitive photo detector materials, micro electromechanical systems and fibre optics, and the perpetual advancement of computing power have both increased the performance and reduced the cost of PAC. As a result, PAC is now a critical part of routine operations within the realm of industrial chemistry.