Cleanroom Editorial and News

  1. The Shift To GMP-Compliant Automation In CGT Manufacturing 10/6/2025

    Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.

  2. MECART Releases Highlights Of Peer-Reviewed Study Assessing Cleanroom Life-Cycle Environmental Impacts 4/22/2026

    MECART, Corp. today announced results of a peer-reviewed life cycle assessment (LCA) that shows its cleanroom systems have lower environmental impacts than those of the average North American cleanroom.

  3. 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.

  4. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

  5. 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.

  6. 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.

  7. 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.

  8. “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.

  9. 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.

  10. 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.