INSIGHTS ON CRITICAL ENVIRONMENTS
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Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And Packaging
The 2022 EU GMP Annex 1 revision marks a pivotal shift in sterile manufacturing, emphasizing contamination control, advanced technologies, and global harmonization—driving industry-wide adaptation and regulatory interpretation challenges.
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Considerations For Tangential Flow Filtration Process Development
Optimize your TFF process with single-pass technology by joining experts Mike Dango and Michael Brauchle as they share key strategies for scalable, efficient filtration process development.
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5 Common Bowie-Dick Test Failures And How To Prevent Them
Bowie-Dick test failures indicate serious sterilization issues. Learn the five most common causes and proven strategies to prevent downtime, compliance risks, and compromised product integrity.
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How Portable Tools Can Help Improve Drug Development Outcomes
As drug pipelines shift toward smaller, more complex therapies, portable bioprocessing tools are helping teams reduce delays, improve data integrity, and enable flexible manufacturing.
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Getting Equipped For The Future With A New Microbial Air Sampler8/25/2025
Discover how a new microbial air sampler meets evolving production demands to enhance compliance, reduce errors, and streamline air monitoring in today’s digital, GMP-regulated environment.
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Nitrosamines - New Requirements To Evaluate Contamination Risks12/23/2024
Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.
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MilliporeSigma Bio-Expo Live February 2025: Downstream Bioprocessing3/17/2025
Advancements in single-use technologies are transforming antibody-drug conjugate manufacturing and offering increased flexibility. Examine key data, design considerations, operational benefits, and applications in ADC production.
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Applying Appropriate Limits In Cleanroom Monitoring6/18/2024
Explore ISO 14644-1:2015 and EU GMP Annex 1 in-depth, and learn about cleanroom classification, how to apply monitoring limits in cleanroom environments, and more.
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Optimizing Microbial Air Sampling To Reduce False Positives In Cleanrooms10/18/2024
Learn how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.
CRITICAL ENVIRONMENT SOLUTIONS
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The APSS-2000 Liquid Particle Counter for USP 788 sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards. When it comes to particle monitoring quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.
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Safeguard your cleanroom environment with secure material transfer solutions. Interlocking pass boxes prevent cross-contamination and maintain critical sterility during item transit.
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Clean punches and dies are essential to maintaining the integrity and efficiency of your tooling investment, as well as the quality of your product. Ultrasonic cleaning has long been considered the most effective, nondestructive way to clean tools – from medical instruments to tablet tooling.
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AES Infinity Glass Wall System® brings the benefits of glass to your cleanroom — added viewing area, versatility, efficiency, and space saving — all while supporting cleanroom sanitary conditions.
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Standard Biological Indicators (BIs) are easy to use and are available for industrial or healthcare use.
FREE CLEANING VALIDATION E-BOOK
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.
