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. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

    Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

  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.