INSIGHTS ON CRITICAL ENVIRONMENTS
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How Digital Cleaning Validation Can Simplify Audit Readiness And Improve Compliance
Discover how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.
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Project Management: Sphere Of Influence
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
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Biofluorescent Particle Counters Are Gaining Momentum
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.
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Contamination Control Strategies: Comparing Cleanrooms, RABS, Isolators
Sterile manufacturing relies on three main contamination control strategies (CCSs): cleanrooms, RABS, and isolators. Understand how each system compares in sterility assurance, startup cost, and operational flexibility.
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Why And Where To Monitor In Aseptic Processing Areas4/24/2025
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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A Shift Towards Biofluorescent Particle Counters In Manufacturing5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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The Impact Of Annex 1 (2022) On Sterility Assurance4/24/2025
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
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Minimizing Residue Build-Up In Cleanrooms10/15/2024
Residues from cleaning agents can pose significant risks to cleanroom operations. Learn about residue management, measurement techniques, and best practices to ensure compliance and product safety.
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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.
CRITICAL ENVIRONMENT SOLUTIONS
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TSI AeroTrak+ Remote Particle Counters offer cleanroom professionals top-notch reliability and no-hassle operation in measuring a wide range of particle sizes, including a 6-channel model with upper size threshold of 25 µm.
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Extract Technology are a leading worldwide supplier of containment and aseptic systems for the pharmaceutical, healthcare, biotech and chemical markets.
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EZTest® is a self-contained biological indicator for monitoring steam/flash steam, ethylene oxide, or hydrogen peroxide sterilization.
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Discover a preventative maintenance service where qualified engineers perform 50 comprehensive tests to ensure peak performance and reliability for your Biacore systems to extend equipment lifespan.
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Reduce microbiological organisms on equipment, in transfer chambers, in filling line isolators and more with Ecolab’s Bioquell IG-2, a robust, fixed bio-decontamination system.
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.
