Cleanroom Editorial and News

  1. Key Takeaways From PDA Ireland Microbiology Event On Innovation And Technology 4/14/2025

    Insights from a PDA Ireland event reveal how innovative technologies like VR and automation are transforming sterile manufacturing, improving efficiency and addressing contamination control strategies.

  2. From Research Stage To GMP Production 9/18/2025

    Discover how to effectively navigate the transition to GMP, ensuring your project meets stringent requirements while streamlining development and minimizing risk.

  3. A "Particular" Problem For Cell Therapy Products, Part 1: Extrinsic And Intrinsic Particles 8/19/2024

    As most cell therapy products are administered intravenously, they need to comply with requirements for particulate matter. This article shares risk mitigation steps and strategies for testing and release.

  4. Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing 7/29/2024

    In Part 2 of a two-part series, Fran DeGrazio explains why best practices in particle testing and related risk-based approaches to product quality should not wait for official regulatory guidances and standards to catch up.

  5. Sterility Assurance: The Fundamentals 10/8/2024

    Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

  6. Operating And Maintaining Pharmaceutical Gas Distribution Systems 9/12/2025

    Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.

  7. Azzur Serves NC Biosciences With "Cleanrooms On Demand" 4/10/2025

    Find out how a national life sciences service company is helping North Carolina startups by providing state-of-the-art facilities in Morrisville for product development and manufacturing to accelerate growth and streamline operations.

  8. Three Key Takeaways: Best Practices In Environmental Monitoring 3/18/2025

    An Environmental Monitoring (EM) program ensures microbial and particulate control in sterile manufacturing. A conference in India covered EM design, data interpretation, contamination risks, and regulatory expectations.

  9. Meeting The Growing Demand For Pre-Filled Syringes 3/7/2023

    The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.

  10. Avoiding IT Outages With Continuous Cleanroom Monitoring Technology 8/13/2024

    Examine how one environmental monitoring system provided seamless and continuous cleanroom monitoring and control during the major global IT outages due to the CrowdStrike incident.