INSIGHTS ON CRITICAL ENVIRONMENTS
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Project Management Process During A Mobile cGMP Compliant Facility Build
Delve into what it took to drive a recent Mobile cGMP Facility from concept to completion.
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Selecting A Platform Filter For High Concentration mAbs
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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Optimal Microbial Sampling Criteria
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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An All-In-One Solution For Residual DNA Quantitation
Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.
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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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How To Implement Three Cleaning Best Practices For Your Cleanroom3/28/2024
Learn about the three cleaning best practices that will make a difference in your cleanroom, the importance of each step, and how to implement these strategies.
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From Open Cleanrooms To Closed Systems – What Is Driving The Change?3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
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Effective Environmental Monitoring And Control In Pharma Operations10/16/2025
A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.
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Optimizing Monitoring: The Science Of Particle Loss11/26/2025
Explore how tubing configuration impacts particle recovery and compliance under Annex 1, using evidence-based guidance, risk assessment tools, and practical strategies to strengthen contamination control.
CRITICAL ENVIRONMENT SOLUTIONS
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Innovative portable particle counter meeting all regulatory requirements.
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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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bioGO® Mobile cleanrooms for radiopharmaceutical preparation and compounding
Discover Germfree’s custom mobile radiopharmaceutical compounding trailer or single module. These all-in-one facilities seamlessly serve individual hospitals or specialty compounding pharmacies
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As the time, costs and complexity of cleaning validation challenges grow, savvy life sciences companies are building a competitive advantage around smarter approaches to cleaning validation.
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Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations regarding the production, storage and testing of their products.
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.
