In the FDA-regulated industry, staying ahead of technological advancements is paramount. At Performance Validation (PV), we understand the evolving needs of our clients and are committed to delivering cutting-edge solutions that transform traditional practices. Introducing the new era of smoke studies and critical airflow visualization – a game-changing approach that empowers clients with unprecedented capabilities […]
At PV, we have a successful history of providing smoke studies to manufacturers in FDA-regulated industries. We understand the importance of accuracy and precision needed to perform a proper study for our clients. For us, it is not just about filming the scenes and writing reports. It is about assisting and guiding our clients through […]
A review of the Form 483’s issued to the 45-registered and inspected 503B Outsourcing Facilities identifies that over 40% (n = 19) of the inspected facilities received one or more observations concerning inadequate smoke studies. Common findings of the smoke studies included studies that were not performed under dynamic conditions, studies that do not adequately reflect […]
Based on a review of FDA Form 483’s issued to compounding facilities for inspections that occurred January to July 2017, 22 separate citations have been identified for critical airflow visualization. Critical airflow is a key element in the protection of sterile product from contamination. A summary of these citations include: The design, construction, and operation […]
Project Leader – Critical Airflow Visualization -
Dalton has supported capital projects for the pharmaceutical and medical device industry since 2002. He has extensive experience with airflow visualization for classified areas and aseptic processing facilities. He has also led multiple large validation projects.
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