This challenge was to complete Critical Airflow Visualization/Verification Studies for an entire aseptic processing area. The aseptic processing area consisted of fifteen separate areas that needed to be examined for critical airflow, including filling lines, lyophilization loading/unloading areas, locally controlled environments, and stopper processing equipment. All spaces classified as Grade A were to be examined and verified as acceptable.
To avoid any disruption in the supply of life saving-medicine manufactured at this facility, the critical airflow visualization studies needed to be completed in a 7-day window.
The video evidence of the Critical Airflow Visualization studies are typically reviewed during regulatory inspection and thus must be of sufficient detail and quality.
Performance Validation provided qualified Team Leaders who provided complete solutions to critical airflow visualization projects (smoke studies). For this project the solution consisted of:
The Critical Airflow Visualization/Verification studies were completed within the allowed 7-day execution window. A review of the video evidence identified that the execution team had provided complete, multi-angle, video evidence of critical airflow. The project team indexed the video evidence which enables the end users the ability to easily and quickly reference executed tests and present this video evidence to auditors.
Performance Validation coordinated with multiple stakeholders to successfully complete the Critical Airflow Visualization/Verification Studies within a short execution window. The studies were completed within budget, on schedule and enabled the facility to resume the manufacturing of life-saving medicines. Meeting the production schedule for restart resulted in no medicinal shortages and no interruption in the supply of these medicines.
For more information please contact:
Michigan Division Director
5168 Sprinkle Road
Portage, MI 49002
Office – (269) 393-9112 X 2752
Cell – (269) 217-0353