INSIGHTS ON CRITICAL ENVIRONMENTS
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EMPQ And Validation Support Services
A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.
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How To Easily And Quickly Monitor Cleanrooms
Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.
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Mobile Sterile Compounding Pharmacy USP 797/800
Learn how Germfree's 53-foot mobile cleanroom trailer ensured uninterrupted sterile drug compounding during a facility renovation.
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5 Key Principles Of Cleanroom Particle Counting
Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.
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Optimal Microbial Sampling Criteria6/24/2025
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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Project Management: Sphere Of Influence10/21/2024
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
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Why Compounding Pharma Manufacturers Should Evaluate BFS Systems12/5/2024
Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.
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Getting Equipped For The Future With A New Microbial Air Sampler8/25/2025
Discover how a new microbial air sampler meets evolving production demands to enhance compliance, reduce errors, and streamline air monitoring in today’s digital, GMP-regulated environment.
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Meet Regulation Requirements With RTU Vials And Cartridges10/9/2025
Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.
CRITICAL ENVIRONMENT SOLUTIONS
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Many pharmaceutical applications require localized Restricted Access Barrier Systems (RABS) within the cleanroom. Germfree’s purpose-built RABS units mitigate the risk of contamination to sterile materials, containers, vials or surfaces that may come into contact with the product. This design provides separation between personnel and product and offer many flexible options for aseptic processing when a Pharmaceutical Isolator is not required.
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AES offers a single resource for virtually every cleanroom application. Our staff of cleanroom professionals create solutions that fit the way you function. Our in-house expertise spans every aspect of cleanroom planning, design, construction and commissioning support. Our innovative pre-engineered modular pharma system is at the core of every AES solution.
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Ensure complete, consistent, and accurate data according to ALCOA+ principles with TSI AeroTrak® Portable APCs.
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AeroTrak Remote Particle Counters with Integrated Pump are ideal for use in any GMP-controlled area where continuous particulate and environmental monitoring is required. AeroTrak Remote Particle Counter Models 6310, 6510 and the vaporized hydrogen peroxide (VHP)-resistant 6510-VHP have the features needed for seamless integration.
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Explore a broad range of ready-to-use culture media designed to detect a wide range of microorganisms and meet the highest requirements of microbial monitoring in sterile production environments.
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.
