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


Brand: PTI
Product: VERIPAC 455


New groundbreaking technology to verify container closure system integrity
VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging (both flexible and rigid).
Testing these types of products demands the highest level of sensitivity, repeatability and accuracy, and the VeriPac 455 is up to the task.
The VeriPac 455 can be incorporated into protocols at any point in the handling process as it is non-destructive, non-invasive and requires no sample preparation.
Applications for this technology include stability studies, clinical trial studies, quality assurance testing and production statistical process control (SPC).
The VeriPac 455 is capable of detecting as little as 0.05 cc/min.
Results have proven to be superior and more reliable than the dye ingress test.
The VeriPac 455 core technology is based on the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing.
This test method was developed using VeriPac leak test instruments.
The VeriPac 455 features patent pending dual vacuum transducer technology that offers increased test sensitivity and produces very consistent, reliable results.
The VeriPac 455 also incorporates significant advances in internet connectivity and networking capabilities that facilitate remote operation, system monitoring and troubleshooting.

- Non-destructive, non-invasive, no sample preparation
- Defect detection down to 0.05 ccm
- Highest level of sensitivity, repeatability and accuracy
- Results proven superior to dye ingress
- Supports sustainable packaging initiatives due to zero waste
- ASTM test method and FDA standard


The VeriPac 455 leak tester connects to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The dual transducer technology 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 absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure.

Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.

Inspection Criteria
- Measures seal integrity of entire container or package
- Measures and verifies container closure system integrity
- Tests for gas leaks for dry products (lyophilized vials, powder filled)
- Tests for liquid leaks (liquid filled vials, pre-filled syringes)


- Micro Leak Detection
- CCIT Container Closure Integrity Testing

Package Type

- Empty & pre-filled syringes
- Liquid filled & lyophilized vials (glass or plastic)
- Filled & sealed bottles, FFS bottles
- Non-porous pouches
- BPC (Bulk Pharmaceutical Chemical) containers
- API (Active Pharmaceutical Ingredient ) containers
- BFS containers
- Ophthalmic dropper tip bottles containing liquid materials
- Glass or plastic ampoules containing liquid materials
- Lidded (nonporous trays or cups) containing liquid materials
- Industries: Markets Served
- Pharmaceutical, nutritional and others

Test Configuration

- Offline laboratory
- Production line applications

Test System

- Dual Transducer Technology

Vacuum Source

- External electric vacuum pump

Test Method*

- Differential vacuum decay

Test Vacuum Range

- Down to 0.1mBar Absolute Vacuum

Operator Interface

- 10" Color Touch Screen

Test Parameter Storage

- Up to 50 packages

Test Sensitivity

- Down to 0.05 ccm (approximate hole size 1.5 micron)

Test Results/Resolution

- Pass/Fail Result
- Absolute Vacuum in mBar and differential in Pascal units

Security Password

- Yes

Remote Internet Access

- Yes

Data Collection

- Collects test data for view on touch screen and electronic data collection
- PC Collection

Test Chamber Tooling

- Manual or automatic

Test Method Approved

ASTM F2338-09**
Mentioned in USP<1207>

Test Instrument Enclosure

- Stainless Steel


- 90 psi required only for automatic test chamber


- Validation Qualification Package (IQ/OQ/PQ)
- Microcalibrator Flowmeter
- CFR21 Part 11 Software


- PDA Journal of Pharmaceutical Science and Technology: Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
- PDA Journal of Pharmaceutical Science and Technology: Vacuum Decay Container/Closure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests