January / February 2020

InTouch

ISPE’s online site for Pharmaceutical Engineering was launched a little over one year ago, in November 2018. Here are some statistics about the site’s success during its first year.

Technical

According to US Pharmacopeia (USP) Chapter <790>, “all parenteral products should be essentially free from any visible particles.”1  This is the first and foremost requirement stated in all pharmacopeia for any injectable product. However, yielding absolutely particle-free...

  • 1United States Pharmacopeia. USP Chapter <790>: Visible Particulates in Injections.
Technical

The Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT) project1 is a recently completed UK-based design manufacture and supply chain research collaboration. This collaboration catalyzed work to define a system for top-down,...

  • 1“ADDoPT—Advanced Digital Design Transforming Pharmaceutical Development and Manufacture.” Accessed 1 September 2019. https://www.addopt.org
Features

As the pharmaceutical industry balances demands for small-batch and blockbuster products and encounters new regulations, there is a need for efficient and safe production technologies that can meet stringent quality and safety requirements for the aseptic filling of drugs. Looking forward, manufacturers should anticipate future format, packaging, and filling needs, and seek technologies with...

Features

Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...

Features

Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,1  the quest for flexible...

  • 1Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.” BioPharm International 2, no. 9 (1989): 20–6.
Features

With the start of the new year, Pharmaceutical Engineering® is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the face of the pharmaceutical industry.

Features

Ranjana B. Pathak, BSc (Hons), MBA, DHA, has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head of Quality, Medical Affairs, and Pharmacovigilance at Cipla Ltd. in Mumbai, India, Pathak’s long tenure has afforded her an informed perspective on the past, present, and future of the industry. An active member of the