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 evidence of the Critical Airflow Visualization studies are typically reviewed during regulatory inspection and thus must be of sufficient detail and quality.
Performance Validation was recommended to this facility based on the work completed at other sites for the same company. Performance Validation provided two qualified Team Leaders who provided complete solutions to critical airflow visualization projects (smoke studies). For this project the solution consisted of:
Working with the customer, Performance Validation gained an understanding of the operation and interventions for the new filling line. Based on our expertise with other critical smoke studies, we were able to communicate potential schedule risks and provide planning to the project team before the initial smoke study activities began. Our expertise also allowed us to visually identify potential airflow problems before beginning the qualification testing.
PV provided guidance for aseptic tool and setup part placement based on actual airflow, minimizing risk to aseptic product, and the ergonomics for different sized aseptic operators.
PV worked with Project Engineers, Quality Professionals, and Corporate Subject Matter Experts to resolve the airflow issues. We helped to explain the airflow and were able to show video recordings to support the discussions about remediation of unacceptable airflow. We provided input on possible solutions for the airflow and supported the examination of potential improvements and changes.
Performance Validation executed the airflow visualization and coordinated the performance and video recording of all production activities including all aseptic interventions. PV supported extended hours of execution to ensure the client’s schedule was kept and a thorough smoke study was completed.
Review and Summary:
Performance Validation performed post-production compilation of video recordings. The final videos were prepared in a manner that both camera angles could be viewed simultaneously. This allows the viewer to get a much better perspective of the air movement in a three dimensional space. PV generated the final summary report for this airflow qualification.
Execution of the final smoke study was completed within schedule and budget. The client was able to approach the upcoming audits of their new filling line with peace-of-mind.
The customer needed the new aseptic filling line to expand their production capacity and improve product quality. The new line integrated all modern aseptic design and controls to ensure the highest product quality. Airflow is a critical aspect of product protection and the client needed expert execution of airflow visualization.
The PV Advantage:
PV was able to provide a complete and thorough airflow qualification package within the short window of availability. PV provided two complete smoke study teams so that multiple areas could be examined and qualified in parallel. Our experience with performing these studies allowed us to move quickly from one scene to the next, evaluate the airflow, and complete the entire effort in a short period of time. Performance Validation remained flexible in final qualification support to minimize any impact on the client’s schedule and worked extended hours to ensure completion of all planned smoke study scenes. PV also worked closely with Production personnel to ensure that all parts and components were ready and available for smoke studies, which is critical to on-schedule completion of a large smoke study project. PV’s deliverables have given this client confidence that their critical airflow meets or exceeds regulatory requirements.
For more information concerning PV’s Smoke Study capabilities please schedule a call with one of our subject matter experts.
Performance Validation, Principle Validation Specialist