INSIGHTS ON CRITICAL ENVIRONMENTS
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A Risk-Based Decision Framework For Selecting Aseptic Barrier Technologies
EU GMP Annex 1 requires a risk-based approach to selecting Isolators or RABS. This framework evaluates human intervention and decontamination to ensure robust sterility assurance.
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Evaluating Carryover When Using A TOC Analyzer
Accurate TOC results shouldn’t depend on sample order. See how low-level measurements remain reliable even after high-TOC analysis, helping reduce false positives and streamline decisions.
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Automated Active Microbial Collection In Aseptic Filling Lines
Learn how automated environmental monitoring strengthens contamination control strategies, reduces risk, and supports intervention planning in aseptic filling lines.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
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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Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques2/26/2025
Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.
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Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?4/20/2026
Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
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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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The Open Standard For Plug-And-Produce4/14/2026
Take a look at how standardized, modular production simplifies line integration, reduces engineering effort, and enables faster changeovers. Ideal for teams seeking flexible manufacturing models.
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Automation-Assisted Washing Of Multicellular 3D Spheroids11/7/2025
Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.
CRITICAL ENVIRONMENT SOLUTIONS
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The Smart-Read™ EZTest® Biological Monitoring System allows an organization to release sterile product with true biological confirmation faster and easier than ever before.
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Accelerate your biomanufacturing capacity with purpose-built modules
KUBio™ box modular bioprocessing environments are designed to help biopharmaceutical manufacturers bring high-quality biopharmaceuticals to market more quickly. By reducing typical design and construction times and streamlining process execution, they support future expansion and replication needs. Available KUBio™ box modular environments for biosafety levels 1 and 2 (BSL-1 and BSL-2) can be delivered in 10 to 15 months for implementation inside existing infrastructure. The result? Reduced project risk, accelerated delivery of next-gen therapies, and greater flexibility at different production scales and product technologies.
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Benefits of TSI's unique FMS 5 product offering.
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Faciflex Express is a pre-designed cleanroom solution that delivers a commissioned cleanroom in as little as 6 months. Pre-designed standard cleanroom layouts are the next generation for snap together installation of modular panel systems. Faciliflex Express has 3 models 5k, 15k, and 30k representing cleanrooms of approximately 5,000, 15,000, and 30,000 square foot.
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The TSI AEROTRAK 9306 Handheld Particle Counter offers the most features and flexibility for customers interested in versatile handheld particle contamination monitoring. The Model 9306 features an ergonomic handle with thumb controls, for easy one-hand operation.
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.
