Pharmaceutical & medical
IdentIfyIng flow measurement solutIons for lIfe scIences
The development of continuous pharmaceutical manufacturing has the potential to transform traditional batch manufacturing (which is associated with excessive costs, high waste, rejections and delays), bringing one of the most significant changes for the industry over the next 10 years. Here, Dr Tracy Brown, head of Life Sciences at TÜV SÜD National Engineering Laboratory, discusses how, in addition to knowledge of production technology, process engineering and the regulatory landscape, sound flow measurement science and standards development will play an important part in bringing CM to life for the pharmaceutical industry. Dr Brown also considers the scientific and technological flow measurement challenges associated with oral solid dosage products.
we face. We have therefore worked with the Institute of Measurement and Control to investigate potential flow measurement requirements within life sciences. This was part of the UK National Measurement System’s R&D programme and is also supporting wider academic research. Continuous manufacturing (CM) has
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the potential to transform medicines manufacturing, bringing compelling advantages to patients, industry and regulators through reduced production costs, faster production times, and smaller physical and environmental footprints,
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ife sciences is evolving rapidly and metrology can facilitate solutions to some of the major healthcare challenges
together with improved quality, scalability and flexibility. The adoption of continuous flow
manufacturing within the pharmaceutical industry brings technical flow measurement challenges. For example, powder flow behaviour can affect manufacturing efficiency and product quality through interruption to the manufacturing process, whilst corrected flow restrictions and stoppages may lead to unwanted variations in pack weight and product performance. Investigation of powder flow properties and
their relationship to particle morphology (shape and size) will improve our understanding of how particle properties impact bulk powder behaviour under various processing conditions
and allow their manipulation to achieve optimum performance in oral solid dosage (OSD) production. Once tablets are compressed, it is then important to attain homogenous enteric coating suspensions flowing into spray guns in coating machines or fluid-bed coaters to prevent coating segregation and gun blockage. Flow metrology is therefore essential
across all stages of OSD production, but it must be the right metrology, capable of identifying what constitutes good and bad flow. Therefore, there is a need to develop fundamental flow metrology infrastructure and standards to support the adoption of advances in pharmaceutical production. Investment is also required to develop solutions using process analytical
June 2021 Instrumentation Monthly
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