Case Studies

Medical Device Manufacturing Facility – Medical Device Quality System Improvement

The Challenge A large mid-western Medical Device company responding to multiple FDA inspections had not made adequate progress towards remediating their quality systems. The company had several hundred products that required remediation and a deadline of 18 months to complete this work. The Solution Performance Validation provided a dedicated consultant who participated with the client’s […]

Critical 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 […]

Dalton Pierson

Project Leader – Critical Airflow Visualization - Dalton has supported capital projects for the pharmaceutical and medical device industry since 2002. He has extensive experience with airflow visualization for classified areas and aseptic processing facilities. He has also led multiple large validation projects.

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