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AT A GLANCE A leading contract research organization (CRO) and full-service cGMP manufacturer (CMO) in Bloomington, IN, installed a brand-new filling line to package pharmaceutical products for its customers. The filling line needed to undergo a smoke study to meet regulatory requirements. With an FDA audit approaching quickly, the CRO partnered with Performance Validation (PV) […]
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How Smoke Studies Optimized Room Pressurization for a Top 5 Pharma Manufacturer
AT A GLANCE A top 5 pharmaceutical manufacturing company in North Chicago, Illinois, partnered with Performance Validation (PV) to perform smoke studies in a building with 14 different areas for packaging, filling, mixing, and bottling. For each area, the team conducted three scenes: a baseline, a material airlock examination, and a personnel airlock examination. The […]
Read MorePharmaceutical manufacturer in Illinois seeks to secure safety of employees’
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 […]
Read MoreA 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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