Quality Featured Articles

  1. Gloveless Robotic Isolators Meet Annex 1 For Aseptic Filling 1/9/2026

    Robotic, gloveless isolators redefine aseptic filling by meeting Annex 1 standards. Discover how this approach ensures product integrity through automation for clinical and commercial manufacturing.

  2. What Is Aseptic Processing? 1/9/2026

    Aseptic processing sterilizes products and packaging separately, then combines them in a sterile environment. See how this method ensures safety, extends shelf life, and protects medicines from contamination.

  3. A Comprehensive Guide To Sampling Protocols And Robust CCI Testing 1/5/2026

    Effective CCI testing hinges on strategic sampling and statistical rigor. Learn why 30 samples matter, how positive controls validate defect detection, and why risk assessment ensures long-term reliability.

  4. Risk Management Across The Pharmaceutical Product Lifecycle 1/5/2026

    Managing risk throughout the pharmaceutical lifecycle requires proactive strategies. Explore advanced detection methods and rigorous sampling that ensure product integrity.

  5. Microbial Ingress No Longer An Effective CCI Test Method 1/5/2026

    Microbial ingress testing is no longer a reliable measure of container closure integrity. Learn why its variability and limitations demand a shift to deterministic methods that deliver accurate results.

  6. Beyond Visual Inspection: Understanding Acoustical Transparency As A PAT 12/29/2025

    Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive approach enhances consistency, reduces risk, and ensures packaging integrity.

  7. 9 Signs Your Pharma Operation Needs An Upgrade 12/22/2025

    Unplanned downtime, audit stress, and missed calibrations signal it’s time to rethink maintenance. Here are nine signs that your operation needs a modern EAM or CMMS to boost compliance and efficiency.

  8. Supporting The Future Of cGMP Drug Product Manufacturing 12/22/2025

    Discover how holistic training and validation services help manufacturers navigate complex regulatory demands and achieve operational readiness faster.

  9. Determining The Limit Of Detection In CCIT 12/18/2025

    Accurately determining the smallest detectable defect in pharmaceutical packaging is essential for sterility. Learn how test sensitivity, positive controls, and regulatory standards shape CCI strategies.

  10. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.