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Mass Extraction Technology FDA Approval for Pharmaceutical Package Leak Testing

Editor: Ahlam Rais

Pfeiffer Vacuum has recently announced that the ATC by Pfeiffer Vacuum Mass Extraction leak testing process meets FDA standard F3287 for leak testing. This shortens the FDA approval process for pharmaceutical products that require leak testing significantly.

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

Companies that utilise the ATC leak testing process will save hundreds of hours of paperwork for the approval application, states the company.

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 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.

It is a tremendous advantage for companies in the pharmaceutical market that utilise ATC’s technology since they save time and costs, mentions the firm.

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Mass Extraction

USP 1207 and ASTM (F-3287-17) recognised ATC Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. According to the company, this patented technology is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials.

Larger defects and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for use in production environments allowing stability control as well as 100 % automated testing (also in inline machines), opines the firm. FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years.