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At A Glance Our team conducted a comprehensive 1-day smoke study for a pharmaceutical client based in Illinois. Although this study was not mandated by the Food and Drug Administration (FDA), it held immense significance for our client. The primary objective was to verify the safety of their employees throughout the production process of a […]
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A Smoke Study “delivers more than expected” at a major pharmaceutical manufacturer in Colorado
AT A GLANCE: A major pharmaceutical manufacturer near Fort Collins, CO required a team of skilled and experienced professionals to complete a smoke study within their aseptic syringe filling suite. DIFFERENT APPROACH TO FIT CLIENT’S NEEDS When Performance Validation (PV) initially met with our client; they stressed the importance of requiring a team of experts […]
Read MoreNew Aseptic Filling Line
The Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) on a new aseptic filling line with active RABS barrier configuration. Additionally, modifications to two existing aseptic filling lines were completed in conjunction with the new filling line. The critical supply chain required completion of airflow visualization in a short window. The video […]
Read MoreCritical Airflow & Smoke Studies for a Manufacturing Facility Upgrade
The Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) after an upgrade to a high-volume filling line with new RABS barriers. Additionally, there were multiple changes to the layout of the line and room were completed in conjunction with the upgrade. The video evidence of the Critical Airflow Visualization studies […]
Read MoreCritical Airflow Visualization & Smoke Studies of Isolator & Rabs
The Challenge: A large manufacturing company required Critical Airflow Visualization testing (Smoke Studies) on two new isolator filling lines and one RABS filling line. The critical supply chain required completion of airflow visualization in a short window. The video evidence of the Critical Airflow Visualization studies are typically reviewed during regulatory inspection and thus must […]
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