Machinery

ATC from Pfeiffer Vacuum gets FDA approval

26 February 2020

Mass Extraction test instrument ME2 from ATC. Source: Pfeiffer VacuumMass Extraction test instrument ME2 from ATC. Source: Pfeiffer VacuumVacuum technology company Pfeiffer Vacuum announced that its Mass Extraction (ATC) leak testing method meets FDA standard F3287 for pharmaceutical package leak testing, which eliminates the requirement for companies using its ATC technology to supply an additional leak testing approval application to the FDA.

FDA approval is necessary whenever a pharmaceutical company launches a new product or makes changes to an existing one. Oftentimes, extensive documentation must be submitted. Yet, with ATC now added to the FDA standard, it is no longer necessary for companies to submit additional paperwork about leak test, test procedure and water ingress. If companies are using ATC equipment, package testing manufacturers only need to state that their product was leak tested in accordance with FDA F3287.

USP 1207 and ASTM (F3287-17) recognized that ATC Mass Extraction technology works on the principle of rarefied gas flow. Testing occurs in vacuum conditions to achieve higher sensitivity. The technology is appropriate for pharmaceutical packaging such as IV-bags, pouches or glass vials and it can also detect larger defects and defects as small as 1 μm. It is suitable for laboratory applications and in production environments.

For more information, visit Pfeiffer Vacuum.

To contact the author of this article, email mdonlon@globalspec.com


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