Critical Environments Columns

  1. Chugai Accelerates Automation To Boost Operational Efficiency 6/3/2026

    What do you do when tasked with producing drugs of different molecular sizes, including highly potent compounds, in the same facility on a global scale? You tap technological advances in automation, modular design for flexibility, and tie it together with systems that enable real-time data.

  2. Navigating Rough Pharma Seas With Collaboration 5/22/2026

    Facing geopolitical, regulatory, and operational complexity, pharma leaders are rethinking supply chains, embracing AI, and simplifying processes. Progress hinges on cross-industry collaboration and shared standards to build resilient, efficient systems.

  3. Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit 5/22/2026

    The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.

  4. Why Contamination Control By Design Should Matter To Your CDMO 5/18/2026

    EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

  5. A 5-Step Foundation For Early CQV Involvement 4/28/2026

    All too often, a project’s issues show up in CQV, and it is there that blame is pointed. However, these issues start earlier and are entirely avoidable with proper planning.

  6. Challenges And Solutions In Aseptic Evolution 4/22/2026

    Aseptic processing has undergone a considerable evolution over the past 35 years in new equipment, standards, procedures, training and regulation. Navigating these challenges is essential to minimizing risk.

  7. Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network 4/17/2026

    Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

  8. Lilly's Toolbox For Fast Track Fill Finish Sites 4/1/2026

    Constructing greenfield fill finish sites is always a complex task, but throw in there the added challenge of delivering the site expediently, and the task becomes increasingly complicated.

  9. 4 Facility Considerations for API Manufacturing 3/25/2026

    Success depends not only on equipment and infrastructure, but also on specialized workforce training, rigorous quality control, robust data management, and increasingly sophisticated supply chain and manufacturing technologies.

  10. Ever Wonder What Running A $50B Capital Facilities Project Feels Like? 3/23/2026

    Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.