Validation, Commissioning & Design Featured Articles

  1. Biotech's Plastic Problem Meets Its Match 8/8/2025

    Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.

  2. What Happens When You Refuse To Compromise On Sustainability? 8/8/2025

    Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.

  3. Redefining Process Design And The Evolution Of Critical Process Parameters 8/6/2025

    Effectively managing process parameters and quality attributes is vital for successful drug development. Learn how a Quality by Design approach can optimize your processes and ensure product quality.

  4. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  5. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  6. Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance 7/28/2025

    Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

  7. Understanding Modern Storage Tank Design And Fabrication 7/28/2025

    Industries rely on advanced storage tanks and pressure vessels to safely manage liquids, gases, and powders. Discover how custom-engineered solutions can enhance efficiency, safety, and compliance.

  8. Optimizing Contamination Control: Strategy Planning And Execution 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  9. Ensuring AI Compliance In Life Sciences: 5 Critical Requirements 7/24/2025

    Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

  10. Why Established Pharma Sites Need A Digital Cleaning Validation Strategy 7/23/2025

    Pharmaceutical facilities face mounting pressure to modernize. Uncover how digital tools are transforming cleaning validation to boost compliance and audit readiness without disruption.