INSIGHTS ON CRITICAL ENVIRONMENTS
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Risked-based Cleaning Validation Process Checklist
Is your cleaning validation process truly aligned with current regulatory expectations? This checklist helps you implement a risk-based approach, focusing resources to effectively mitigate your highest-risk areas.
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The Crucial Role Of Cleaning In Effective VPHP Decontamination For Isolators
Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.
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Effective Cleaning Strategies For Irregular Surfaces In Cleanrooms
Explore effective strategies and cleaning supplies to ensure irregular cleanroom surfaces, such as light switches, door handles, valves, and piping, maintain the same standards as more accessible areas.
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Advances In Regulations For Viable Environmental Monitoring
Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
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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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The Ex-Regulator's View On Small Surface Contamination Control2/26/2025
Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. Learn about the critical steps, techniques, and validation needed to ensure product safety.
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The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets3/28/2024
Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.
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Integration From Formulation Development To Manufacturing, Packaging2/27/2025
Adare Pharma Solutions' Pessano, Italy facility offers 220,000 sq. ft. of end-to-end services, including R&D, formulation development, clinical and commercial manufacturing, packaging, and advanced analytical capabilities.
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Overview Of Biological Indicator And Sterilization Monitoring Systems7/2/2024
Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.
CRITICAL ENVIRONMENT SOLUTIONS
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Providing a suitable cGMP environment for operators to perform either sampling or dispensing task in a safe and comfortable atmosphere, Extract Technology facilities are high class state of art pieces of equipment. Complete with material and personnel airlocks and a downflow booth, the facility operates with a positive pressure to aid in achieving a clean cGMP environment.
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Viable, Non Viable and Environmental Monitoring Software.
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Extract Technology aseptic isolators are designed to allow operators to perform aseptic processes in a sterile environment providing assurance of process integrity.
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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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Leverage our state-of-the-art virtual twin technology for powerful insights, collaboration, and decision-making. Our partnerships with NavVis Digital Twin Technology and Prevu3D empower us to create detailed 3D representations of your systems, facilities, operations, and real-time data to enhance facility management.
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.
