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


Brand: PTI
Product: VERIPAC 425


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 dry filled packages with defect profile typically >5 microns

Package Type

- Filled & sealed pouches, cups, trays
- Empty trays & cups
- Pouches

Package Materials & Combinations

- Foil
- Film
- Aluminum
- Plastic & Laminated Materials

Test Configuration

- Offline laboratory
- Production line applications

Test System

- Dual Transducer Technology

Vacuum Source

- Integrated vacuum pump

Test Method*

- Differential Vacuum Decay

Test Vacuum Range

- Down to 250 mBar Absolute Vacuum (22 inHg)

Operator Interface

- 10" Color Touch Screen

Test Parameter Storage

- Up to 50 packages

Test Sensitivity

- 0.2 ccm (Approximate hole size 5 microns)

Test Results/Resolution

- Pass/Fail
- Result in mBar units an Pascal units

Security Password

- Yes

Remote Internet Access

- Yes

Data Collection

- View on touch screen and electronic
- Printer Option

Test Chamber

- Manual or semi-automatic

ASTM Test Method

- ASTM F2338-09**

Test Instrument Enclosure

- Stainless Steel

Air Supply

- Maximum 90 psi


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