Cleanroom Editorial and News

  1. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

    Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

  2. Your Environmental Monitoring Can't Be Your Only Line Of Defense 9/1/2025

    Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

  3. Solutions For Safe, Efficient, And High-Purity Automation Applications 6/12/2025

    At this year’s Automatica trade fair, the Fraunhofer Institute for Manufacturing Engineering and Automation IPA will be showcasing numerous solutions that – thanks in part to artificial intelligence (AI) – greatly simplify and accelerate the planning, programming, and training of robots.

  4. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.

  5. “Futureproofing” Cleanroom Facilities 1/10/2024

    Explore factors that can impact the flexibility of your biopharmaceutical facility and cleanrooms as new designs are "futureproofed" to allow for a rapid response to changes in market demands.

  6. Biofluorescent Particle Counters Are Gaining Momentum 4/28/2025

    The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

  7. 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.

  8. FAQs On The Revised EU GMP Annex 1: Volume 3 9/21/2025

    The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

  9. 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.

  10. 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.