Cleanroom Editorial and News

  1. What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry? 8/1/2024

    The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

  2. Empowering Glove Integrity Testing: Successful End User Training On The Esco IntelliGlove Tester (EIGT) In Bangladesh 3/19/2026

    Advanced wireless testing ensures glove and barrier integrity in sterile manufacturing. These tools support ISO compliance and Annex 1 standards to strengthen contamination control.

  3. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

    Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

  4. Industry Insights In Isolator Technologies And Aseptic Processing In Pharma 8/30/2024

    Explore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.

  5. Monitoring, Media Fills, And QC: Demonstrating Sterility Assurance At Your CDMO 2/13/2026

    CDMO guide on environmental monitoring, media fills, and QC to prove sterility assurance in aseptic manufacturing—key elements of the Contamination Control Strategy beyond facility design.

  6. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  7. 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.

  8. 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.

  9. 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.

  10. 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.