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The Challenge:
A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) after an upgrade to a high-volume filling line with new RABS barriers. Additionally, there were multiple changes to the layout of the line and room were completed in conjunction with the upgrade. The video evidence of the Critical Airflow Visualization studies is typically reviewed during regulatory inspection and thus must be of sufficient detail and quality.
The Solution:
Performance Validation provided qualified Team Leaders who provided complete solutions to critical airflow visualization projects (smoke studies). Performance Validation was recommended to this facility based on the work completed at other sites for the same company. For this project the solution consisted of:
Planning:
Working with the customer, Performance Validation gained an understanding of the issues the site faced with previous smoke studies and developed a plan that would meet all of their needs. Based on our expertise with other critical smoke studies, we were able to communicate potential risks and provide planning and preparation guidance to the project team before the initial smoke study commissioning activities began. PV worked with on-site professionals to mitigate these risks early in the project.
Commissioning:
Performance Validation supported commissioning of the critical airflow within the newly redesigned Grade-A space. We worked with Aseptic Operators and Quality Professionals to determine how to best perform interventions. Different techniques of performing interventions were analyzed, airflow examined for each, and best practices were determined. PV provided guidance for aseptic tool placement based on actual airflow, minimizing risk to aseptic product, and the ergonomics for different sized aseptic operators.
Some areas of unacceptable airflow were identified during the initial examination. 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 barrier and air balancing changes.
Qualification:
Performance Validation executed the airflow visualization qualification protocol and coordinated the performance and video recording of all production activities including all aseptic interventions. In addition, PV trained client personnel in proper methods for performing a Critical Airflow Qualification.
Review and Summary:
Performance Validation performed post-production compilation of video recordings and indexing of the final videos. This allows for quick and accurate retrieval of specific filmed activities during audits. PV also supported the quality review of these videos and supplied explanations for quality questions. PV generated the final summary report for this airflow qualification.
The Results
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 Benefits
Performance Validation was able to help this client uncover and resolve airflow issues that would have threatened the cleanliness of the line and products produced on the line. PV was able to provide a complete and thorough airflow qualification package that was a vast improvement over their past airflow qualification efforts. One engineer, upon viewing the final videos, described them as a “phenomenal” improvement. PV’s deliverables have given this client confidence that their critical airflow meets or exceeds regulatory requirements.
The PV Advantage:
Performance Validations’ experience with performing smoke studies and resolving airflow issues allowed us to provide guidance to quickly remediate airflow issues. Our flexibility allowed us to adjust to the client’s needs for final qualification execution. 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 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.
For more information concerning PV’s Smoke Study capabilities please schedule a call with one of our subject matter experts.
Dalton Pierson
Performance Validation,
Principle Validation Specialist
