Cleanroom Editorial and News
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Benefits Of Isolator Technology In Fill-Finish
12/10/2025
Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.