Critical Environments Columns

  1. 6 Reasons Pharma Manufacturing Has Eyes On Puerto Rico 8/1/2026

    Several advantages explain why Puerto Rico continues to attract pharma investment, especially as manufacturers reassess supply chain risk and look for options closer to the U.S. mainland.

  2. Bayer Adds A Spine To Modularity For Scale Without Disruption 7/16/2026

    Modular facility concepts offer a different path, giving manufacturers the ability to expand capacity stepwise, standardize core infrastructure, and adapt production environments as product portfolios evolve

  3. 7 Facilities Pilot PreCheck for Faster Approval 7/13/2026

    A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.

  4. How To Avoid The Biggest USP <665> Compliance Trap 6/30/2026

    U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.

  5. Inside Chugai's Digital Infrastructure Strategy 6/29/2026

    When a facility is fully automated and designed for manufacturing flexibility, it needs a digital infrastructure that pulls the systems together, reports data accurately and efficiently, and recognizes areas for continuous improvement.

  6. What Biopharma Often Overlooks In A Scheduled Shutdown 6/26/2026

    Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

  7. 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.

  8. 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.

  9. 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.

  10. 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.