Critical Environments Columns

  1. Process Engineering's Key Role In Sterile Injectable Facility Design 2/24/2026

    Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

  2. The Rise Of The Autonomous Pharma Plant 2/18/2026

    What does a production facility of the future look like? That’s exactly what Bayer management asked its team before planning began for the world’s most modern pharmaceutical facility, Solida 1.

  3. A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset 2/18/2026

    Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

  4. At Base Camp: Lilly's Manufacturing Capacity Journey 2/13/2026

    In 2025 alone, Lilly announced plans to build new facilities in Texas, Alabama, Virginia and Pennsylvania in addition to facility expansions in Indiana, Wisconsin and Puerto Rico.

  5. Solving The Top 3 Pharma Packaging/Manufacturing Issues 2/5/2026

    Regulatory changes, space/footprint constraints and expanding automation garnered more votes than the other challenges. Let’s explore these challenges, and see how the industry is tackling them as we move into 2026.

  6. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

  7. A 2025 Pharma Look Back and Look Forward: Editor Style 1/7/2026

    Though I still have a great deal to learn about the pharmaceutical industry, I am surrounded by a warm and incredibly bright cast of editors that I gain knowledge from every day.

  8. It's Copy/Paste In Fleet Management Manufacturing 12/11/2025

    Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.”  In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities.

  9. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

    A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

  10. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.