The Challenge A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the qualification of a suite of DeltaV automation modules that support continuous manufacturing facilities around the globe. The suite consisted of 38 DeltaV modules and phases that were interconnected and worked in tandem to automate the continuous manufacturing process. The modules […]
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Overview A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not […]
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The Challenge A client contacted Performance Validation requesting assistance with the commissioning of a pediatric research center renovation project. The research center was to be located within a renovated 2nd floor of an old building that is part of a children’s hospital and was to include exam space for patients participating in clinical research programs as […]
Read MoreThe 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 […]
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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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