Regulatory Articles

  1. Choosing The Right PCD Configuration For Reliable Sterility Assurance 10/16/2025

    Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

  2. Navigating PFAS: Preparing For Regulatory Hurdles In Medical Devices 9/13/2025

    Learn how to be more proactive by implementing robust PFAS testing and control strategies to safeguard patient health, protect your brand, and stay ahead of evolving regulations.

  3. Leverage Apps To Reduce Line Changeover Time From 14 Days To 3 6/26/2025

    A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

  4. The 5 Ws Of A Human Factors Strategy 3/31/2025

    A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

  5. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

    Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

  6. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

  7. Sustainable Solutions For Medical Devices 1/6/2025

    Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

  8. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

    Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

  9. Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs 8/27/2024

    Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

  10. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.