Force Decay Pharmaceutical Leak Testing System

The VeriPac 410 inspection technology platform combines the sensitivity and reliability of PTI’s vacuum decay technology while introducing a force-based measurement to enhance results. The 410’s force decay technology is capable of measuring force from the surface deflection of a pharmaceutical package during a normal vacuum based test cycle. This force measurement of the package surface allows the VeriPac 410 to identify which package is defective while also being able to leak test pharmaceutical packages with minimal headspace.

The test system uses a nested tooling to position the package in a consistent location and to limit the unmeasured expansion of the package being tested. Once the test is initiated, a vacuum is drawn on the test chamber causing the package to expand within the chamber. Vacuum levels are monitored during the test cycle to evaluate the package using the ASTM F2338 vacuum decay leak test method. The expansion of the package being tested applies force to the VeriPac force measurement system.

Multiple packages can be tested per test cycle with the force decay measurement system identifying if there any defective packages. Defective packages show a decay in the expansion force or vacuum level during the test cycle. The location of the defective package or cavity is identified. Force decay is the most effective technology to deploy when multi-cavity package formats are being tested.

Force Decay Leak Testing

The force decay technology becomes a vital element of the vacuum based leak test when package formats have lower headspace. Packages with little internal volume may leak out all measurable airflow before a vacuum measurement can be taken. In such low volume applications, the package activity and expansion during the leak test becomes a valuable data point to assure the integrity of the package.

The VeriPac 410 force decay technology has been successfully validated on multiple package categories including blister packages, transdermal patch sachets, and low headspace suture packs. For all applications, defects below 20 microns were the targeted leak size for inspection.

Benefits

• Non-destructive, non-invasive, no sample preparation
• Accurate and repeatable results
• Test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA consensus standard
• Cost effective with rapid return on investment