New groundbreaking technology to verify container closure system integrity VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging (both flexible and rigid). Testing these types of products demands the highest level of sensitivity, repeatability and accuracy, and the VeriPac 455 is up to the task. The VeriPac 455 can be incorporated into protocols at any point in the handling process as it is non-destructive, non-invasive and requires no sample preparation. Applications for this technology include stability studies, clinical trial studies, quality assurance testing and production statistical process control (SPC). The VeriPac 455 is capable of detecting as little as 0.05 cc/min. Results have proven to be superior and more reliable than the dye ingress test. The VeriPac 455 core technology is based on the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. The VeriPac 455 features patent pending dual vacuum transducer technology that offers increased test sensitivity and produces very consistent, reliable results. The VeriPac 455 also incorporates significant advances in internet connectivity and networking capabilities that facilitate remote operation, system monitoring and troubleshooting.
Benefits - Non-destructive, non-invasive, no sample preparation - Defect detection down to 0.05 ccm - Highest level of sensitivity, repeatability and accuracy - Results proven superior to dye ingress - Supports sustainable packaging initiatives due to zero waste - ASTM test method and FDA standard
The VeriPac 455 leak tester connects to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The dual transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure.
Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
Inspection Criteria - Measures seal integrity of entire container or package - Measures and verifies container closure system integrity - Tests for gas leaks for dry products (lyophilized vials, powder filled) - Tests for liquid leaks (liquid filled vials, pre-filled syringes)