INSIGHTS ON CRITICAL ENVIRONMENTS
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![Environmental Monitoring Systems: Why And Where To Monitor In Aseptic Processing Areas Splash]( "Why And Where To Monitor In Aseptic Processing Areas")
Why And Where To Monitor In Aseptic Processing AreasAnnex 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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![Pipette With Cell Culture Plate-GettyImages-520238063]( "Automation-Assisted Washing Of Multicellular 3D Spheroids")
Automation-Assisted Washing Of Multicellular 3D SpheroidsAutomated 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.
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![GettyImages-2150276083-lab-mask-tablet-PPE-cleanroom]( "Top 3 Things To Consider When Designing A Risk-Based Cleaning Validation Process")
Top 3 Things To Consider When Designing A Risk-Based Cleaning Validation ProcessLearn how implementing a systematic approach to cleaning validation can significantly enhance compliance and improve your audit readiness.
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![Quickly Set Up A Zone For Efficient Cleanroom Monitoring]( "Quickly Set Up A Zone For Efficient Cleanroom Monitoring")
Quickly Set Up A Zone For Efficient Cleanroom MonitoringWatch to see how easy it is to start collecting data according to your standard operating procedure with a portable particle counter.
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Single-Use Strategies For Uninterrupted Microbial Monitoring2/22/2024
Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.
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Selecting A Platform Filter For High Concentration mAbs4/9/2025
Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.
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Biotech's Plastic Problem Meets Its Match8/8/2025
Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.
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Integration From Formulation Development To Manufacturing, Packaging2/27/2025
Adare Pharma Solutions' Pessano, Italy facility offers 220,000 sq. ft. of end-to-end services, including R&D, formulation development, clinical and commercial manufacturing, packaging, and advanced analytical capabilities.
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Monitor Cleanrooms Anytime, Anywhere8/4/2025
Remotely monitor cleanroom environments with secure, real-time data access from any device, anywhere, helping to streamline operations and ensure compliance.
CRITICAL ENVIRONMENT SOLUTIONS
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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![express30k]( "Pre-Designed Pharmaceutical Cleanroom: Express 30K, 10 Months Delivery")
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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![pharma manufacturer 450x300.jpg]( "Periodic Cleanroom Monitoring")
TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.
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![annex-1]( "Annex 1-Compliant Real-Time Viable Particle Counter")
What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
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![TSI BIOTRAK]( "Continuous And Intervention-Free Microbial Monitoring")
Explore the benefits of a biofluorescent particle counter that provides real-time viable and total particle monitoring of critical environments, including the aseptic core, without the need for operator intervention.
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.
