Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are Online Exclusives. These are PE articles published exclusively on the website; you can always find them here. Here is a selection from the first two years of Online Exclusives on...
Continuous processing is not new to the pharmaceutical industry. Today, the majority of major pharmaceutical companies at least consider continuous processes when developing new small-molecule entities. In contrast, the biopharmaceutical industry has been slow to adopt continuous platforms, particularly related to high volume processes. This...
The ISPE Aseptic Conference is back and in-person for 2022! We have a great line-up of speakers during the two-day conference, and of course, a great group for the Interactive Regulatory Panel. The...
When most people hear “Facility of the Future,” they immediately think about robots, automation, virtual reality, or logging in with a Facebook account, security issues aside. However, when I hear “Facility of the Future,” I think of lean manufacturing and flexibility. The majority of my career has been on the design side, where I focused on building facilities. Historically, the projects I...
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical Quality System (PQS), along with QRM. Since then, the industry has acknowledged the...
