` VeriPac 415

PTI Packaging Technologies and Inspection

VeriPac 415

Non-destructive, non-subjective and require no sample preparation

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VeriPac test systems are non-destructive, non-subjective and require no sample preparation. Test fixtures are designed to inspect flexible, rigid and semi-rigid packaging. VeriPac inspection systems use cutting edge innovation to provide repeatable, more sensitive, and more robust detection of defects. VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method F2338, which is listed in ISO 11607, USP <1207> and is a FDA recognized consensus standard for package integrity testing. 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 statistical process control (SPC). VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats. Leak detection of high risk applications requires the highest level of test measurement reliability. The VeriPac series has redefined the reliability and accuracy of test measurement systems.

 BENEFITS

• Deterministic, quantitative test method
• Defect detection down to 0.034 cc/min.
• Highest level of repeatability andaccuracy
• Cost effective with rapid returnon investment
• Simplifies the inspection andvalidation process
• Results proven superior to dye ingress
• ASTM test method and FDA standard
• USP <1207> Compliant
INSPECTION CRITERIA
• Measures seal integrity of entire container or package
• Measures and verifies container closure integrity
• Altitude package testing

Applications • Non-destructive leak detection for packages with defect profile typically >5 microns
• Altitude package testing
Package Type • Filled & sealed bottles, cups, trays
• Empty trays & cups • Pouches
Packaging Materials & Combinations Foil, Film, Aluminum, Plastic, Glass & Laminated Materials
Test Configuration • Offline laboratory • Production line applications
Test System Dual Transducer PERMA-Vac Technology*
Test Method* Differential Vacuum Decay
Operator Interface 10” Color Touch Screen
Test Parameter Storage Up to 20 products (ETHOS 21 CFR, Part 11 software provides unlimited product storage)
Base Unit Test Sensitivity** 0.034 cc/min (Approximate hole size 2 micron)
Application Sensitivity*** 0.22 cc/min (Approximate hole size 5 micron)
Test Results/Resolution Pass/Fail Result in mBar and Pascal units
CFR Security Capability Yes (21 CFR, Part 11) PTI ETHOS Software
Manufacturing Execution Systems (MES) Integration Yes
Data Collection View on HMI touch screen and electronic data collection
Printer Option Yes
Test Chamber Manual or semi-automatic
Recognized Test Method • ASTM F2338-09—Non-destructive vacuum decay leak testing
• ASTM D6653-13—Test method for high altitude package testing – www.astm.org
• USP <1207> compliant
Test Instrument Enclosure Tester Stainless Stee
Dimensions 14.5” W – 22” D – 12” H
Weight 35 lbs.
Power 100-240 VAC; 50/60 cycles
Air 90 psi
Options Validation Qualification Package (IQ/OQ) / Microcalibrator Flowmeter


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