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            India

            Leak Testing

            How to Shorten Approval Times

            | Editor: Anke Geipel-Kern

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

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

            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 hundreds of hours of paperwork for the approval application, the company says. USP 1207 and ASTM (F-3287-17) recognized ATC Mass Extraction Technology works on the principle of rarefied gas flow.

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