Facing the Pharmaceutical Future

In 2013, pharmaceutical manufacturers will be increasingly drawn to the simplicity and speed of single-use systems, which easily meet industry standards. Assembled in DIN ISO 14644-1 class 7 cleanrooms, the latest single-use components are connected to the product stream via sterile plug-and-play connections and are easily removed, bagged and disposed of without breaking connections and exposing the environment to the product. Market-leading experts offer ready-to-install solutions that can easily be validated. Flow behavior, interfaces, tubing layout, distribution and connection aspects are pursued using a holistic approach. This makes new single-use filling systems precise and safe, easy to connect and operate and allow significant time savings on product changeovers.

Improving Productivity

In general, rising cost pressures in production will press manufacturers to further improve productivity with respect to OEE over the next few years. Large-scale production of generics will increasingly be relocated to the emerging markets, prompting demand for durable, highly productive machines. To maintain and improve a plant’s Overall Equipment Effectiveness (OEE), aftermarket services are becoming more and more important as well.

OEE is equally important when it comes to the development and market introduction of new pharmaceuticals. So far, the production of small batches continues to be an expensive venture. But with the optimization of machines in terms of flexibility, automation, easy changeover and scale-up, the situation has changed significantly — and will continue to do so in the future. These improvements enable manufacturers to develop new drugs with shorter time-to-market metrics, while complying with strict or emerging regulations. Pharmaceutical companies that invest in machinery and services along the pharmaceutical value chain clearly will have an advantage and lead the industry to an exciting future of changes and opportunities.

Published in the February issue of Pharmaceutical Manufacturing magazine

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References
1. IMS Institute for Healthcare Informatics (2012): “The Global Use of Medicines: Outlook Through 2016.”
2. Http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm127615.pdf
3. http://www.fiercepharma.com/press-releases/global-high-potency-active-pharmaceutical-ingredients-hpapis-market-expecte
• http://www.pharmaceuticalonline.com/doc.mvc/bosch-presents-enhanced-inspection-technology-portfolio-0001
• http://www.boschpackaging.com/Boschpharma-us/eng/3414.asp
• http://www.contractpharma.com/issues/2011-06/view_features/single-use-disposable-systems-for-aseptic-fill-fin/
• http://www.boschpackaging.com/boschpackagingservices/eng/OEE_Consulting_69722.asp

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About the author
Dr. Jérôme Freissmuth studied technical chemistry at the Technical University of Vienna, Austria. He holds a doctorate in technical science and has worked as a management consultant focusing on strategy and organizational projects for the pharmaceutical machinery industry and process industry for several years. In 2010, Freissmuth joined Robert Bosch GmbH as Director of Business Development, Product Management and Marketing in the Packaging Technology division, Business Unit Pharma. He can be reached at Jerome.Freissmuth@bosch.com.