Martin Gadsby, Director at Optimal Industrial Technologies, looks at how PAT can slash the environmental impact of medical plastic manufacturing activities whilst creating valuable opportunities for process improvement.
Design flexibility, light weight, biocompatibility and the ability of some plastics to undergo sterilisation processes without this downgrading their physicochemical properties are some of the many reasons why plastic is widely used in medical and drug delivery devices. However, this material has recently come under scrutiny due to its environmental impact.
The use of PAT can help address these concerns by significantly improving the efficiency of raw material production, manufacturing and recycling processes whilst increasing the quality of the final products. This is a system for designing, analysing, and controlling critical process parameters (CPPs) in manufacturing through timely measurements of critical quality attributes (CQAs) defining quality target product profiles (QTTP).
Ultimately, by using multivariate analysis (MVA) and chemometric models to link CQAs and CPPs, PAT aims to optimise industrial processes by offering an in-depth understanding of the manufacturing processes involved. This PAT process knowledge is presented in an easily accessible manner to plant operators via software platforms, such as Optimal’s synTQ knowledge management suite, allowing on-the-fly adjustments of CPPs to meet CQA targets.
The result can be greener manufacturing with lower energy usage, and less waste.
PAT reduces solvent use
Key targets of PAT-led process improvement include reducing energy consumption, waste generation and substandard material production. These goals are some of the main objectives of green chemistry, a movement founded in the 1990’s (1) . As a result, businesses producing plastic-based medical and drug delivery devices can leverage this methodology to develop a system that promotes built-in quality as well as sustainability.
In addition to the general resources being used in the manufacturing of medical plastic, there are other resources whose use, and waste treatment, can be heavily reduced by PAT-led production, such as hazardous chemicals and solvents. These are substances of high environmental concern, as their synthesis, application and disposal can release pollutants into the air, water or soil. Even more, solvent regeneration is one of the most energy and volume intensive components of related industrial processes and can therefore lead to substantial energy costs for any industry.
Consequently, by using lower amounts of these chemicals – another key issue of the green chemistry manifesto – while increasing the overall outcome, manufacturing facilities can minimise the environmental impact of their processes (2).
PAT supports the transition towards greener processes
Process optimisation also means shifting from batch processing to continuous flow, and PAT acts as the ideal gateway to continuous processing. This is inherently more sustainable than batch manufacturing, due to lower energy expenditure. For example, a number of pieces of equipment, such as extruders, do not need to go through cycles of heating at the beginning of every batch process and cooling at the end of it.
Advanced PAT knowledge management platforms, such as synTQ, also offer ‘Digital Twin’ functions. These further reduce the volume of resources used, waste generated and energy consumed, by allowing medical plastic manufacturers to develop, run and test a process data flow before an actual, physical process is started up.
PAT as a gateway for greener quality testing
PAT’s contribution to developing a cleaner industrial environment does not solely influence the medical plastic manufacturing process, but also encourages the development and implementation of eco-friendly analytical practices in quality control.
The in-line testing procedures at the core of PAT greatly simplify the testing workflow. By doing so, test sample packaging, transport, storage and preservation activities are no longer taking place, as analysis is performed in-line. As a consequence, waste production and energy usage resulting from these tasks are completely eliminated.
Re-calibration is also heavily reduced when performing in-line measurements, further limiting reagent and energy consumption, as well as waste generation, by avoiding the use of calibration solutions, standards and reference materials.
The nature of the analytical techniques utilised in PAT-led quality assurance also contributes to lowering their environmental impact. Much of the analysis performed is non-destructive. Therefore, it doesnot generate any of the waste associated with material testing. Moreover, they do not require solvents for sample preparation.
A green way ahead
A substantial decline in waste formation, as well as resource and energy use, also results in substantial cost reduction, making PAT an interesting tool for businesses in any manufacturing sector. It is therefore clear how medical plastic manufacturers that have not yet implemented a PAT strategy are missing out not only on an opportunity to improve the environmental profile of their production processes and quality testing, but also the associated economic benefits resulting from resource and waste minimisation or avoidance. By choosing a PAT specialist partner, such as Optimal Industrial Technologies, businesses can rely on their extensive system and application expertise to reap the benefits of going green.
(1) Original “manifesto”: Anastas PT, Warner JC. Green Chemistry: Theory and Practice. New York: Oxford University Press; 1998
Image 1: PAT offers a key tool to medical plastic manufacturers interested in slashing the environmental impact of their activities as well as creating valuable opportunities for process improvement.
Image 2: Plant operators can have a clear view and understanding of PAT process knowledge by using software platforms, such as Optimal’s synTQ knowledge management suite, which also allows them to make on-the-fly adjustments of CPPs to meet CQA targets.
Within the Optimal group, we have more than 30 years’ experience in the automation and optimisation of control and data management systems for the food, chemical, pharmaceutical, biotech, life science and other process industries.
The demands being placed on manufacturers in relation to getting products to market sooner, minimising development and production costs together with increasing product quality and business sustainability are ever increasing. Our primary aim is to deliver measurable improvements in all these target areas.
In addition to practical automation and system integration expertise, Optimal Industrial Technologies has also developed the world-leading PAT Knowledge Management software platform – synTQ® – which is used by over 60% of the world’s leading pharmaceutical and biotech companies, and is now being adopted by other process industries. synTQ has been a proven enabler of QbD via PAT by significantly increasing productivity and quality, while reducing waste, time to manufacture and time to market for batch and continuous processes.
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Optimal Industrial Technologies: Martin Gadsby
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