Cleanroom Editorial and News

  1. “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.

  2. Retrofitting Facilities For Modern Bioprocessing And Pharma Production 3/11/2025

    The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.

  3. 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.

  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. 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. 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.

  10. 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.