Continuous manufacturing is increasing rapidly in Europe’s pharmaceuticals sector after expanding only slowly for several years. In 2016, Europe had—at 35%—the largest share of world pharmaceuticals output through continuous processes, according to a report by Transparency Market Research (TMR), Albany, New York, on the global continuous manufacturing market, which it forecasts will grow by a compound annual growth rate of 8.8% in 2017–2025.
Automation and digitization
TMR expects Europe to retain its leading position as it maintains an above average growth rate, mainly due to the availability of advanced technologies and the greater number of technology providers in the region, led by Siemens AG of Germany. The rise in the introduction of continuous manufacturing technologies, however, has not been accompanied by a similar strong increase in the use of automation, or in particular, the adoption of digitization through the application of sensor-based on-line monitoring. The industry in Europe appears to be holding back from introducing advanced digitalized measuring equipment, data analytics, and advanced automated controls to raise the efficiency of its manufacturing practices. There has, for example, only been cautious use of automated real-time release testing (RTRT) for on-line or in-line measuring and controlling of the quality and specifications of medicine components.
“A number of manufacturers have implemented use of instrumentation such as near infrared (NIR) or Raman spectroscopy for gathering information on processes, and in the case of active substance manufacture, for determining reaction end points,” explains an official at Ireland’s Health Products Regulatory Authority (HPRA), Dublin, in an interview with Pharmaceutical Technology Europe. “However, not many have implemented these as fully operating real-time release systems,” he adds.
By Sean Milmo
Volume 41, Issue 11, pg 8-9
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