INSIGHTS ON CRITICAL ENVIRONMENTS
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Why And Where To Monitor In Aseptic Processing Areas
Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.
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Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination
Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.
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The Advantages Of Creating A Workflow When Monitoring A Cleanroom
Discover a portable particle counter that enables you to create a scheduled workflow and ensure you never miss a sample during cleanroom monitoring or sample the wrong area.
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The Very Real Consequences Of Ignoring Cleanroom Residues
Learn about the problems caused by residues left behind by disinfectant solutions, challenges to residue removal in cleanrooms, and effective removal techniques for ongoing residue management.
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Enhancing Facility Operations with Digital Twin Technology6/28/2024
Join us for an insightful webinar where we explore the transformative power of Digital Twin technology in modern facility management
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Considerations For Tangential Flow Filtration Process Development5/27/2025
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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Uncovering Blind Spots In Environmental Monitoring6/19/2025
Discover how modern strategies like the Contamination Control Strategy are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative microbial methods.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance12/8/2025
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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What Happens When You Refuse To Compromise On Sustainability?8/8/2025
Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.
CRITICAL ENVIRONMENT SOLUTIONS
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Explore an imaging system that offers a modular design and extensive configuration options to allow for customization and easy upgrades that is integrated with modern software.
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Extract Technology aseptic isolators are designed to allow operators to perform aseptic processes in a sterile environment providing assurance of process integrity.
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In the spectrum of pharmaceutical manufacturing facilities, injectable product manufacturing facilities represent the most sophisticated and challenging to design, build, qualify and operate, particularly when products manufactured in these facilities are rendered sterile when complete, ready to inject directly into a human. For this reason, very careful consideration must be made when developing such a facility.
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Protecting Product and Process
Straddle Laminar Airflow units are used to provide product and process protection for large scale applications that would not be possible inside a standard laminar flow hood. Additionally, Straddle LAF units can be used to house robotic machines, such as those used for aseptic vial filling, closing, and capping. In many applications, use of a Straddle LAF can eliminate the need for an ISO 5 or better cleanroom.
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Arcoform protective shrouds are a modular system made of fire-retardant resin, embedded glass strand fiber-mat, and finished with the Arcoplast high-gloss antimicrobial GelCoat surface.
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.
