INSIGHTS ON CRITICAL ENVIRONMENTS
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Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance
Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.
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A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks
A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.
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The Pain Of Change – Could Suppliers Be Part Of The Cure?
Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
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Tour Of Germfree's bioGO® Mobile cGMP Cleanroom
Go step by step through a cleanroom with cutting-edge features and functionalities of our Mobile Cleanroom, which offers a flexible solution for aseptic processing needs.
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Nitrosamines - New Requirements To Evaluate Contamination Risks12/23/2024
Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.
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6 Reasons To Use Biological Indicators During Your Sterilization Cycle2/13/2024
Understand the importance of biological indicators, and learn why they should be integral to any comprehensive sterilization program.
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Monitoring Compressed Gases For Microbial And Particle Contamination2/26/2025
There are several factors associated with active environmental microbial monitoring. Watch to learn how the EU GMP Annex 1 compliance focuses on microbial monitoring in cleanrooms.
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Environmental Microbial Monitoring In Advancing Automation5/22/2025
Watch how a single-use microbial impactor revolutionizes contamination control in robotic filling lines to enhance sterility, efficiency, and compliance in fully automated manufacturing environments.
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Minimizing Cleanroom Contamination Risks In Drug Manufacturing7/2/2024
Considering ergonomics is crucial for optimizing cleaning efficiency and minimizing contamination risks. Explore key ergonomic considerations in cleanroom cleaning, best practices, and more.
CRITICAL ENVIRONMENT SOLUTIONS
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Isolators are a core component to the pharmaceutical industry critical for a range of processes. These gas-tight enclosures provide a complete barrier to ensure aseptic conditions and containment.
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Alconox detergents set the standard for critical cleaning. Scientitsts, engineers, and professionals specify Alconox detergents in their cleaning procedures for optimum economy, environmental safety, and performance.
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Sensitivity range: 0.3 - 25.0 µm; 1.0 CFM (28.3 LPM) - Built-in vacuum, PoE, VHP resistant
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Discover a system meticulously designed and rigorously tested for durability and reliability, which can operate efficiently for 10 years or more under normal conditions with the proper maintenance.
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Explore a preventive maintenance service where an engineer conducts comprehensive tests and replaces necessary components with high-quality parts to ensure optimal performance for your oligonucleotide synthesizer.
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.
