INSIGHTS ON CRITICAL ENVIRONMENTS
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The Case For Pre-Owned Equipment In Drug Manufacturing
Discover how used equipment can deliver faster ROI by eliminating long lead times and reducing capital outlay, allowing for quicker production and revenue generation.
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Navigating The Paradigm Shift: Ensuring Efficacy In Risk-Based Cleaning Validation
Unearth how adopting a risk-based approach to cleaning validation can enhance product quality, safety, and regulatory compliance in pharmaceutical manufacturing.
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Optimizing Contamination Control: Strategy Planning And Execution
A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.
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Sustainability By Design In API Manufacturing
Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.
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Mobile Sterile Compounding Pharmacy USP 797/8006/19/2024
Learn how Germfree's 53-foot mobile cleanroom trailer ensured uninterrupted sterile drug compounding during a facility renovation.
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Expanding CDMO Advanced Therapy Manufacturing Capability With BSL-2LS cGMP Facility6/6/2024
See how one manufacturer expanded its production capacity with a modular BSL-2LS cGMP facility built to meet evolving CDMO needs while ensuring robust engineering controls and flexible design.
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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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Avoiding IT Outages With Continuous Cleanroom Monitoring Technology8/13/2024
Examine how one environmental monitoring system provided seamless and continuous cleanroom monitoring and control during the major global IT outages due to the CrowdStrike incident.
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Establishing Effective Visual Residue Limits In Cleaning Validation10/23/2024
Learn about the technical nuances of Visual Residue Limits (VRLs) determination and explore strategies to implement robust VRL programs that meet regulatory standards and enhance manufacturing efficiency.
CRITICAL ENVIRONMENT SOLUTIONS
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Optimize pharmaceutical manufacturing with real-time cleaning data, audit readiness, and automated compliance. This end-to-end compliance platform empowers companies to meet stringent regulatory standards.
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Germfree has leveraged our decades of facility design experience to develop a pass-through (airlock) that is uniquely engineered to meet the demands of a modern pharmaceutical cleanroom. All stainless steel construction with coved interior and exterior corners and a pharmaceutical grade finish make these pass-through boxes the most cleanable and robust on the market.
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We construct the AES modular cleanroom system at our wholly owned manufacturing facility in order to ensure quality and cleanliness from the start. Our state-of-the-art facility only manufactures cleanroom systems and components, learn more:
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A-1010 Bio-Seal is supplied as a twin cartridge equal mix, high strength aliphaticurethane structural adhesive that bonds, seals and finishes in a single application, it is touch dry in 12 hours and fully cured in 72 hours.
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The healthcare industry demands durable, cleanable, and safe environments. Arcoplast offers a comprehensive solution for critical areas like operating rooms, cleanrooms, and compounding pharmacies.
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.
