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. How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage 9/15/2025

    It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical.

  3. 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.

  4. The Systems And Choreography Needed For Grade B ATMP Material Transfer 3/31/2026

    Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

  5. 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.

  6. How To Choose The Right Isolator For Cell Therapy 2/4/2026

    Closed isolator systems provide Grade A aseptic environments necessary for cGMP cell therapy scaling. By integrating essential equipment and automation, these systems ensure rigorous quality control.

  7. Preparing Global Parenteral Sites For Annex 1 Compliance 9/1/2026

    Modern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.

  8. 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.

  9. 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.

  10. The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets 3/28/2024

    Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.