Cleanroom Editorial and News

  1. 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.

  2. Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings 2/14/2025

    Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

  3. 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.

  4. 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.

  5. 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.

  6. Rising Allure And Critical Considerations Of Point-Of-Care Processing 8/1/2024

    Mobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.

  7. 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.

  8. 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.

  9. Choosing The Right Primary Container And Troubleshooting Issues 8/25/2023

    Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.

  10. Design And Function Of GMP Transition Spaces 6/12/2024

    In pharma/biotech GMP, there are several spaces that function as transition spaces, such as air locks. This deep dive discusses how procedure and arrangement can influence their effectiveness.