Articles By Eric Larson

  1. Planning For Scale Up: Building For Long Term Flexibility 8/31/2026

    Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.

  2. Minimizing Particulate Risk: Designing For Control 8/31/2026

    Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.

  3. Protecting Your Drug Product: Integrating Engineering And Quality 8/31/2026

    Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.

  4. Establishing A Container Closure System — Engineering For Integrity 8/31/2026

    CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.

  5. Start Packaging Development Early: De-Risk Before You Build 8/31/2026

    When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.

  6. Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide 8/31/2026

    This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

  7. 08.30.26 -- CSV Assumes The AI System Sits Still — It Doesn't. 8/30/2026
    08/30/26 Med Device Online Newsletter
  8. Tissues, Complex Materials: Why Toxicology-Chemistry Collaboration Matters 8/28/2026

    Learn how close collaboration between analytical chemists and toxicologists can strengthen chemical characterization studies and improve regulatory outcomes for complex medical device materials.

  9. 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery 8/27/2026

    08/27/26 Med Device Online Newsletter

  10. 08.27.26 -- New Insights For Safer, Smarter Medtech 8/27/2026
    08/27/26 Med Device Online Newsletter