Cleanroom Editorial and News

  1. 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.

  2. 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.

  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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.