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Process Analytical Technology: what’s the score?

10 June 2015

Should the food industry be taking up PAT at line faster than it currently is?

Process Analytical Technology (PAT) has been popular in the pharmaceutical industry since the Food and Drug Administration (FDA) issued it’s guidance in 2004 for PAT as a framework for innovative development, manufacturing and quality assurance. Now, over a decade later, the food industry is being encouraged to increase its uptake of PAT as a route towards process optimisation, leading to improved product consistency and reduced out-of-spec material, and ultimately for the real-time release of products.

What is it?
PAT looks to move from static batch manufacturing to a more dynamic approach. “It should help meet the central aims of increased manufacturing profitability whilst maintaining product quality,” says Anthony Hartell, NIR Product Manager at BUCHI UK, a solution provider for laboratory technology for R&D, quality control and production. He describes PAT as an application of four different interlinked technologies; 
1)multivariate data acquisition and analysis;
2)process visualisation;
3)knowledge management; and
4)suitable process analyser

The aim is to control the manufacturing processes through the measurement of Critical Control Parameters (CPP) which affect Critical Quality Attributes (CQA). PAT only works if the analyser and software utilised are harmonically integrated within a specific production line to provide real-time control for the process. By implementing a PAT analyser, a host of parameters can be measured, from levels of protein, sugar, fat, fibre, starch or gluten, to product homogeneity and density, product traceability, shape, colour or size.

“In general, the food industry has been slow to adopt PAT to its full potential, preferring instead to rely on off-line laboratory quality controls,” says Hartell. “In practice, these are simply not fast enough to allow a manufacturer to realise the main benefits of PAT, which are reduced over-processing, enhancing product consistency and minimising the production of rejects.”

PAT for food manufacturing
“In our view, the implementation of PAT is essential for the food industry,” says Dagmar Behmer, International Support & Marketing NIR at Bruker Optics, an analytical instrumentation company. “Most companies offer a highly diversified product portfolio, operating large-scale, often continuous manufacturing production sites. By introducing real-time process monitoring with spectroscopic sensors, the industry can move away from time-consuming off-line analyses towards the continuous control of main quality parameters.”

In order to benefit the most from any changes being made to existing production sites, it is necessary to gain as much information as possible from the technology. “Many of the currently available technologies are limited to analysing one or two constituents or properties,” says Behmer. “Technologies like ultrasound, microwave sensors, density meters and others are often not specific in terms of receiving dedicated chemical information from different components. Moreover, they tend to depend on physical changes in the sample, for example texture and fat droplet size. Vibrational methods however are highly specific and offer detailed chemical information for the qualitative and quantitative analysis of the materials.”

Hartell, on the other hand, argues that while improvements to multivariate data analysis and process visualisation tools have continued to make gains in recent years, the widespread adoption of actual in-line monitoring within the food industry has generally been hampered by limitations of available process analysers.

“In general, process analysers that have been easy to use and implement are inflexible and difficult to maintain,” says Hartell. “While those that have offered the desired levels of flexibility have, in the past, been complicated to operate and maintain over extended periods. But a new generation of dedicated process analysers have appeared on the market in recent years that combine advanced software algorithms with the latest dedicated hardware designs, which gives the market an in-line analytical solution that is both easy to use at an operator level but that doesn’t suffer from the same levels of inflexibility of earlier process sensors.”

Near infrared spectroscopy is a popular choice for inline analysis, thanks to its non-destructive nature, the lack of sample preparation required and the speed with which it can deliver precise results. They can determine physical parameters such as particle size distribution and density, water content and solvent content.

“Near infrared spectroscopy has been a well-established technique in the agricultural sector for decades,” says Behmer. “Modern FT-NIR process spectrometers offer an array of contact and non-contact sensors for the analysis of liquid, solid and semi-solid samples alike, so there is little limitation on the products that can be analysed online. Using light fibre technology, one spectrometer can monitor multiple sensors which can be hundreds of metres apart, reducing the cost per sensor significantly.”

Bruker’s MATRIX-F FT-NIR spectrometer can be operated not only with conventional fibre optic probes and flow cells, but also with contactless measurement heads, which can be implemented into pipes, bypasses and even over conveyor belts. Up to six sensors can be multiplexed by a single MATRIX-F FT-NIR spectrometer.

“One application example is the monitoring of the milk powder process,” adds Behmer. “The key points in the spray drying process can be monitored by installing sensors for example in the storage tanks, the inline feed of the spray dryer and at the powder outlet of the fluid bed dryer.”

With the challenges that can arise when a new sensor technology is interfaced to an existing plant, and possibly limited engineering knowledge bringing production to a halt, but most PAT providers have a team of technical specialists who understand the issues, can investigate any problems and will design and manufacture a technical solution based on FT-NIR spectroscopy that will be fit for purpose, including a transfer of existing evaluation methods. 

BUCHI’s NIR-Online® sensors combine different measurement options in a single unit (e.g. NIR, VIS spectrometers and a CCD camera), and plant operation managers can monitor their CPP e.g. directly into tanks, pipes or on conveyor belts, no matter the flow rate. 

“By combining the latest generation of process analysers with recent developments in the three other PAT tools, those involved in food production can now easily and fully realise the benefits of this approach and monitor their processes in real-time,” says Hartell. “Although historically the food industry has been slow to realise the benefits of PAT, the rate of its implementation into the food processing arena is likely to accelerate over the coming years.”

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