Manufacturers of parenteral drug products face numerous challenges to fulfilling their business needs. Often, the business needs themselves are difficult to define for the long term. The trend of fewer high volume products and more low volume, niche products requires a well-planned operational strategy. The need to manufacture more specialized products with a diversity of drug delivery formats poses challenges in designing new or renovated manufacturing facilities for companies that must control capital spending, while still aiming for a design that will function for years to come. Fortunately, facility and process technologies are keeping pace with industry needs perhaps better than ever before. These include increased automation, barrier technology, single-use and ready to use components, and flexible format filling lines. Yet, the availability of solutions does not automatically yield an efficient and compliant facility. A disciplined, holistic approach to design and selection of technology increases the chance of success in meeting immediate and long term business needs. Here we explore critical elements to design and how they integrate today’s state-of-the-art technologies.

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