VeriPac Vacuum Decay technology is referenced in new USP <1207> Chapter on Package Integrity Testing
VeriPac inspection systems are deterministic test methods for package integrity testing that produce reliable and robust quantitative test data. VeriPac systems can be easily integrated into the packaging process to improve quality, reduce waste, and provide operators with a clearer understanding of package quality.
VeriPac test systems are non-destructive, non-invasive and require no sample preparation. Test fixtures are designed to inspect flexible, rigid and semi-rigid packaging. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. VeriPac’s inspection method is more reliable, cost effective and efficient than destructive methods, plus it eliminates subjective, misleading results that vary from operator to operator.
VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method F2338 recognized by the FDA as a consensus standard for package integrity testing. (ASTM F2338 www.astm.org). This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines. Applications for VeriPac technology include stability studies, clinical trials, quality assurance testing and production statistical process control (SPC). VeriPac testers feature a patented single or dual vacuum transducer technology, PERMA-Vac, that has increased test sensitivity resulting in very consistent, reliable results.
Test components are optimized according to the type of package being tested and the level of sensitivity required. VeriPac leak testers are designed to inspect flexible, rigid and semi-rigid packaging including Tyvek® trays.
The VeriPac 400 Series also features a secondary Altitude Test Mode in accordance with ASTM Test Method D6653-13. Switching from vacuum decay mode to altitude mode in less than one minute, VeriPac systems can identify burst seals, leaks, and other integrity defects generated from altitude related package stress during the test, identifying the exact time and pressure of a package failure.