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. 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.

  3. Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology 11/17/2023

    Building the right cleanroom involves critical early decisions. Learn about a methodical framework ensuring flexibility, compliance, and operational readiness from initial concept through delivery.

  4. “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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.