INSIGHTS ON CRITICAL ENVIRONMENTS
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![Virtual Pharm Expo]( "Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And Packaging")
Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And PackagingThe 2022 EU GMP Annex 1 revision marks a pivotal shift in sterile manufacturing, emphasizing contamination control, advanced technologies, and global harmonization—driving industry-wide adaptation and regulatory interpretation challenges.
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![GettyImages-1349793348 DNA]( "The Status Quo Of Oligonucleotides Is Not The Future")
The Status Quo Of Oligonucleotides Is Not The FutureThe oligonucleotide field is booming, but manufacturing challenges loom. Experts discuss optimizing production for these promising therapies with flexible, sustainable, and high-yield approaches.
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![bsl-2-mobile-exterior]( "Bringing Clinical Testing To New Heights In New Jersey")
Bringing Clinical Testing To New Heights In New JerseyExplore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.
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![Compliance GettyImages-1212446127]( "Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques")
Understanding ISO/TR 14644-21 Airborne Particle Sampling TechniquesIndustry 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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A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks6/6/2024
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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Mobile Advanced Therapies Facility6/19/2024
Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.
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What Is OPC Counting Efficiency?6/24/2025
Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.
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EU ANNEX-1 And The Impact Of Contamination Control Strategy On Cleaning & Disinfection10/21/2024
New EU rules tighten grip on contamination control for sterile drugs. Learn how to ensure your cleaning and disinfection meet the stricter standards.
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Driving Innovation In Decentralized Manufacturing3/27/2025
Unlock the potential of localized manufacturing and see how cutting-edge technology is transforming access to essential medications, ensuring patients get what they need.
CRITICAL ENVIRONMENT SOLUTIONS
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![PharmaceuticalIsolationSystems]( "Pharmaceutical Isolation Systems For Blow/Fill/Seal Equipment")
Insertion technology for ASEP-TECH® Blow/Fill/Seal systems was pioneered by Weiler Engineering, Inc. The technology incorporates the use of a barrier isolator, typically located outside the machine room and integrated with the BFS machine. Sterile inserts such as tip and cap assemblies or multi-entry rubber stoppers are loaded into the isolator (which is maintained at Class 100 conditions) through a rapid transfer port.
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![PROSAT® Theta™ Wipes]( "Pharmaceutical Cleanroom Wipes: Presaturated Wipes")
Presaturated cleaning wipes can offer many benefits over bottled solvents and dry wipes for cleanroom use. Contec’s presaturated wipes help reduce solvent use, increase convenience in hand wiping, reduce airborne VOCs, and increase process control and reliability.
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![GettyImages-1214112149-lab-team-collaboration-research]( "Vaporized Hydrogen Peroxide Biological Indicators")
APEX Biological Indicator products are designed specifically for the pharmaceutical and medical device industries utilizing H2O2 vapor sterilization. The stainless steel carrier is designed for use with today’s isolator and filling line applications.
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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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![Samsung]( "Super Plant 4")
Our accumulated expertise is implemented with the latest technologies and innovation, so that Plant 4 will be able to serve as part of your global presence, becoming your future biomanufacturing hub.
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.
