Isolator and RABS Critical Airflow Visualization (Smoke Studies)


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 be of sufficient detail and quality.

The Solution:

Performance Validation was contacted by this facility based on the work described on the company website.  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:

Planning:

Working with the customer, Performance Validation gained an understanding of the operation and interventions for the new filling lines.  Based on our expertise with other critical smoke studies, we were able to visually identify potential airflow visualization and video recording challenges before beginning the qualification testing.  Performance Validation created solutions to solve these challenges before arriving on-site.

Qualification:

Based on our expertise with other critical smoke studies, we were able to efficiently learn the facilities airflow visualization procedures and qualification protocols.  PV provided guidance for aseptic tool placement based on actual airflow, minimizing risk to aseptic product.

PV worked with Project Engineers and Quality Professionals to resolve the airflow issues as they were identified.  We were able to show live video on large external monitors to support the discussions about airflow, and work together to determine optimal camera and fog placement.  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.

The Results

Execution of the final smoke study was completed ahead of schedule and within the budget.  The client was able to approach the upcoming audits of their new filling lines with peace-of-mind.

The Benefits

Completion of the airflow visualization testing completed the qualification of the three new aseptic filling lines.  These new lines integrated all modern aseptic design and controls to ensure the highest product quality. Completion of qualification of the new filling lines enabled the customer to expand their production capacity and improve product quality.

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 to the client’s schedule and worked extended hours to ensure completion of all planned smoke study scenes.  PV’s deliverables have given this client confidence that their critical airflow meets or exceeds regulatory requirements.

For more information concerning PV’s Critical Airflow Visualization and Qualification capabilities please use our Contact Us page or contact:

Dalton Pierson
Performance Validation, Critical Airflow Services Manager
Principle Validation Specialist
Cell: (269) 270-4319