ASTM F2338-09 - USP <1207> - GMP - CCIT - Container Closure Integrity Testing


Brand: PTI
Product: VERIPAC 225/4


VeriPac inspection systems evaluate and analyze package integrity with precision and repeatability.
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.
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 recognized by the FDA as a consensus standard for package integrity testing (ASTM F2338).
This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines.
VeriPac's non-destructive technology is capable of detecting package leaks and invisible defects using an absolute or differential pressure transducer leak test system. 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.


- Non-destructive Leak detection for packages with defect profile typically >25 microns

Package Type

- Filled & sealed pouches
- Flexible & semi-rigid packaging
- Industries: Markets Served
- Medical Device, Pharmaceutical, Food
- Package Materials& Combinations
- Tyvek®, Paper, Foil, Film, Aluminum, Plastic & Laminated Materials

Test type

- On-line or Off-line Testing
- Semi-automatic online or offline leak testing applications

Test Components

- Absolute Vacuum Transducer


- Vacuum Decay

Operator Interface

- Touch Screen

Test Result Data

- Pass/Fail Result
- Absolute vacuum measured in mbar/sec.
- Differential vacuum measured in Pa/sec.

Statistics & Test Results Trends

- Yes, including result trends for each test station

Data Collection

- View test result data on touch screen
- Electronic data collection (unlimited test data)

Test Chamber

- Four Stations - product loading, product testing, discharge and reject

ASTM Test Method

- ASTM F2338
- FDA Standard #014; Item 168

Package Defect

- Measures whole seal integrity and leak tests entire package

Main Air

- Maximum 90 psi


- Microcalibrator Flowmeter
- Validation Qualification Package (IQ/OQ/PQ)