Pfeiffer Vacuum receives FDA approval for ATC
Pfeiffer Vacuum has announced that its Mass Extraction (ATC) leak testing process meets FDA standard F3287 for pharmaceutical package leak testing, eliminating the need for companies using its ATC technology to submit a separate leak testing approval application to the FDA.
When a pharmaceutical company launches a new product or changes an existing one, FDA approval is required, and extensive documentation must be submitted. However, with ATC now added to the FDA standard, companies do not need to submit paperwork regarding leak test, test procedure, water ingress. If they are using ATC equipment, package testing manufacturers can simply declare that their product is leak tested in accordance with FDA F3287.
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. This technology is suitable 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.