Page 5 - Automated issue 14 - Maintenance matters

MAINTENANCE MATTERS
Quality by design Another emerging trend in the pharmaceutical Due to the enforcement of pharmaceutical industry is personalised medicine. Due to the niche
regulations, the expense and risks associated with R&D led companies to steer their focus from drug development to gaining market share. This meant improving the efficiency and productivity of manufacturing processes and the quality of finished products, which could be achieved according to the Quality by Design (QbD) paradigm.
The QbD paradigm was first outlined by Joseph Juran, who believed that quality could be planned and that most quality crises were due to failings in product design. Pharmaceutical manufacturers, inspired by the QbD paradigm, began designing products with quality in mind. This enabled them to reduce the chance of batch failure, generate a greater return on investment and ensure consistent manufacturing of high quality products.
Emerging trends
Until recently, the pharmaceutical industry relied on batch manufacturing to produce medicines, but continuous manufacturing is now increasing in popularity. Transitioning from batch to continuous manufacturing reduces downtime, waste production and the need to reboot systems, saving time, energy and money.
In 2016, Europe had the largest share of world pharmaceuticals output from continuous processes — at 35 per cent — according to a report by Transparency Market Research. However, some pharmaceutical companies are hesitant to invest in the machinery required for continuous manufacturing without guidance and approval from regulatory agencies. This can be resolved by retrofitting obsolete equipment that already has regulatory approval.
portion of the population that a personalised product caters for, pharmaceutical manufacturers must be able to efficiently produce products in small quantities. Their processes must also be flexible so that they can switch between drugs on a single production line.
“There is considerable scope for automation to further change the industry beyond recognition”
The end of the timeline, for now
Improvements in pharmaceutical manufacturing have traditionally been guided by regulatory changes. The driving forces for change now include automation and artificial intelligence.
Big Pharma is already experiencing the benefits of automation. Automated guided vehicles (AGVs) are transporting goods around facilities, robots are performing physical tasks with high precision and Raman spectroscopy is conducting post-manufacturing quality analyses. However, there is considerable scope for automation to further change the industry beyond recognition.
Thanks to the improvements over recent decades, we now have more options for healthcare than herbs and rituals. We can be confident that the pharmaceutical products we use are safe, effective and fully tested.
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