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Milestone Vacuum Technology

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Pfeiffer

Leak Testing How to Shorten Approval Times

| Editor: Anke Geipel-Kern

The ATC Mass Extraction leak testing process now meets FDA standard F3287 for leak testing.

Related Company

Mass Extraction test instrument ME2 from ATC by Pfeiffer Vacuum
Mass Extraction test instrument ME2 from ATC by Pfeiffer Vacuum
(Source: Pfeiffer Vakuum)

When a pharmaceutical company launches a new product or changes an existing product, FDA approval is required. Normally, companies have to submit extensive documentation. However, with ATC from Pfeiffer Vacuum being added to the FDA standard, companies do not need to submit paperwork regarding leak test, test procedure, water ingress, and package testing. Manufacturers can simply declare that their product is leak tested in accordance with FDA F3287 by using ATC equipment, thus adhering to the standard. This shortens the FDA approval process for pharmaceutical products that require leak testing significantly. Companies that utilize the ATC leak testing process will save paperwork for the approval application.

Large and Small Defects

USP 1207 and ASTM (F-3287-17) recognized ATC Mass Extraction Technology works on the principle of rarefied gas flow. The technology is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials and for laboratory applications as well as for use in production environments allowing stability control as well as 100 % automated testing (also in inline machines). Larger defects and defects as small as 1 μm can be detected with this method. FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over ten years.

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