Critical Environments Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

    Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

  8. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  9. Raising The Bar In Radiopharmaceutical Manufacturing 3/12/2026

    Ratio Therapeutics chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.

  10. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

    Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.