ASTM F2338-09 - GMP - CCIT - USP<1207>


Brand: PTI



The VeriPac D-Series are versatile non-destructive package inspection systems specially designed for pouches and flexible packaging.
VeriPac inspection systems provide a qualitative result (PASS or FAIL) as well as quantitative data that correlates to leak rate and leak size.
To accommodate various package specifications and test sensitivity requirements, the VeriPac D-Series is available in several configurations for both the leak test instrument and the test chamber capacity.
The VeriPac D-Series utilize an ASTM approved non-destructive vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing.
This test method was developed using VeriPac leak test instruments.
VeriPac D-Series inspection systems are a practical alternative to destructive testing because they eliminate the subjective results, the waste and cost associated with these methods.
Vacuum decay leak testing technology has proven to provide a rapid return on investment when compared to destructive methods, such as the water bath test.
VeriPac D-Series testers have also resolved the issue of finding critical defects that affect product quality and shelf life.
Since VeriPac test cycles are very short and testing is non-destructive, both the number of samples and testing frequency can be increased.


- Non-destructive, non-invasive, no sample preparation
- Accurate and repeatable results
- Test multiple packages in a single test cycle
- Cost effective with rapid return on investment
- Supports sustainable packaging initiatives due to zero waste
- Simplifies the inspection and validation process
- ASTM test method and FDA standard


The VeriPac tester is connected to a specially designed drawer-style test chamber for easy handling and testing convenience.
Each VeriPac D-Series model achieves a specific range of test sensitivity and is available with two test chamber drawer sizes depending upon the package size and specifications. The unique difference with this test configuration is how the package is tested. PTI utilizes its patented flexible membrane that conforms to the package shape and size. Multiple packages can be tested in a single test cycle. The flexible membrane will reduce test chamber head space for maximum test sensitivity. The single or dual vacuum transducer 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 vacuum indicate the presence of leaks and defects within the package. The VeriPac D-Series testers are also capable of testing different size pouches, stick packs and sachets without any changeover in parts or system settings.

Inspection Criteria

- Measures seal integrity of entire package
- Test sensitivity range from 5 - 25 microns

Test sensitivity 5 to 25 microns


- Non-destructive leak detection for dry filled packages with defect profile typically >5 microns

Package Type

- Pouches and flexible packaging made of non-porous materials
- Poly peelable chevron pouches
- Stick packs and sachets

Package Materials & Combinations
- Non-porous materials: foil, plastic, poly, film, Aluminum

Test Configuration

- Offline laboratory
- Production line automation

- Veripac 310/D Single Trasducer
- Veripac 415/D Single trasducer
- Veripac 425/D Dual Transducer Technology

Vacuum Source
- Integrated vacuum pump

Test Method*
- Veripac 310/D Vacuum Decay
- Veripac 415/D Vacuum Decay
- Veripac 425/D Differential Vacuum Decay

Test Vacuum Range
- Down to 250 mBar Absolute Vacuum (22 inHg)

Operator Interface

- Colour Touch Screen
- VeriPac 310/D 6" Color Touch Screen
- VeriPac 415/D 10" Color Touch Screen
- VeriPac 425/D 10" Color Touch Screen

Test parameter set

- VeriPac 310/D up to 30
- VeriPac 415/D up to 50
- VeriPac 425/D up to 50

Test sensitivity

- VeriPac 310/D 3.4 ccm (about 20 microns)
- VeriPac 415/D 2 ccm (about 15 microns)
- VeriPac 425/D 0.2 ccm (about 5 microns)


- Conform/Non Conform
- Results in mBar (absolute vacuum) and Pascal (differential vacuum)

Password protected login

- VeriPac 310/D No
- VeriPac 415/D Yes
- VeriPac 425/D Yes

Remote access

- VeriPac 310/D No
- VeriPac 415/D Yes
- VeriPac 425/D Yes

Data archive

- View on touch screen and electronic export via PC connection
- CFR 21 Part 11 (optional)

Test chamber

- Manual or Automatic
- Test drawer with flexible membrane: Large drawer (24.5" x 14.5") or Small drawer (8.5" x 14.5")

ASTM Method

- ASTM F2338-09

Test Instrument Enclosure

- Stainless Steel


- 90 psi


- Microcalibrator flowmeter
- Validation qualification package (IQ/OQ/PQ)