Industry Insights

  1. FAQs On The Revised EU GMP Annex 1: Volume 7 2/4/2026

    Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

  2. FAQs On The Revised EU GMP Annex 1: Volume 8 2/4/2026

    Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

  3. Part I: Defining The Dye Ingress Operating Window 2/4/2026

    Dye ingress testing depends on pressure dynamics that shift with viscosity. Discover how these constraints narrow its operating window and call into question its reliability for high‑risk applications.

  4. Engineering Excellence In Container Closure Integrity Testing 1/30/2026

    Explore the critical factors that define a reliable container closure integrity method, as well as what truly distinguishes robust, reproducible testing in today’s demanding parenteral landscape.

  5. A Holistic Approach To CCI Is A Deterministic Approach 1/30/2026

    A modern approach to CCI blends smart design, risk‑based strategies, and deterministic testing to safeguard sterile products. Learn how lifecycle thinking and practical sampling plans strengthen quality.

  6. Managing PFAS Uncertainty: What Medical Device Teams Can Do Today 1/29/2026

    Success requires mapping material dependencies, addressing unintentional exposure, and documenting a defensible rationale for functional materials to ensure supply chain resilience and patient safety.

  7. Mitigating Intricacies, Challenges Of CCI Inspection Of Cryostorage Bags 1/27/2026

    Implementing deterministic integrity testing with surrogate formulations is essential to identify hidden defects, ensuring biological products remain sterile and potent throughout the supply chain.

  8. Incorporating DART In Medical Device Toxicological Risk Assessments 1/27/2026

    The revised ISO 10993-3 emphasizes chemical characterization and risk assessment to evaluate developmental and reproductive toxicity. Learn how to assess devices to ensure patient safety.

  9. 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.

  10. 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.