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INDIANAPOLIS, June 21, 2018 /PRNewswire/ -- Performance Validation is excited to announce the launch of our dedicated Critical Airflow Visualization (CAV) or Smoke Study Services. Multiple life science companies have experienced challenges in the performance or documentation of critical airflow which is intended to protect sterile products during aseptic operations (503B Smoke Study Issues,Aseptic Filling CAV). Performance Validation a nationwide leader in commissioning, qualification and validation has executed over 30 projects primarily focused on documenting critical airflow, and collectively has over 5,500 hours of experience in the planning, development, execution, and summarizing or post production editing of video data.
During FDA inspections of Pharmaceutical manufacturers or 503B Outsourcing facilities, FDA inspectors will review the video recordings of smoke study tests to verify unidirectional airflow and sweeping action over and away from the product. Typical issues identified during inspection include:
- Lack of smoke study tests under dynamic conditions.
- Incomplete smoke studies (not all areas were tested)
- Studies that did not accurately reflect firm's aseptic practices
- No visual recording of the smoke studies.
- Critical airflow failures that were not remedied.
Performance Validation can field a team of smoke study experts that have the knowledge, experience, and training to ensure the recorded critical airflow is complete and meets the regulatory expectations. Our critical airflow recordings are subjected to frequent regulatory review and we are able to integrate any feedback into our processes ensuring compliance in a constantly changing environment.
Dalton Pierson, Performance Validation's CAV subject matter expert said, "Our experience in performing smoke studies is allowing us to advise clients on improvements to equipment and processes, but to also identify potential airflow issues before recording the airflow." One customer had struggled for years to get acceptable smoke studies on their many aseptic filling lines. That customer described PV's final videos as "phenomenal" compared to what they had before.
About PV: Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
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SOURCE Performance Validation, Inc.
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