In GMP-regulated manufacturing environments, smoke studies for GMP compliance play a critical role in protecting product quality and patient safety. Airflow is one of the most important environmental controls, and critical airflow visualization remains a foundational requirement for demonstrating effective contamination control. As regulatory expectations evolve and cleanroom designs become more complex, airflow assurance has become more than a routine qualification […]
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In pharmaceutical manufacturing, airflow visualization—commonly known as a smoke study—is more than a box to check for regulatory compliance. It is a critical tool for confirming that your cleanroom’s airflow is functioning as designed to protect both product integrity and patient safety. But not all smoke studies are created equal. More and more, we are […]
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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 […]
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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 […]
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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 […]
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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 […]
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