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Container closure integrity testing (CCIT) or leak testing is an important process in the manufacturing phase of a pharmaceutical drug product in particular parenteral products. CCIT is performed to evaluate and maintain sterility over the shelf life of a product as well as to prevent contamination of the product from moisture, reactive gases, or micro-organisms. In earlier times, dye ingress, microbiological ingress and other probabilistic test methods were being used in the industry. However, the results produced by such methods lacked accuracy, reliability and were highly subjective. Therefore, manufacturers are now replacing probabilistic test methods with deterministic methods, which reduce the needs for sample preparation and validation and provide more accurate detection of leaks and defects.

Why is VeriPac 465 effective in highly sensitive micro leak testing?

PTI's VeriPac 465 is a deterministic, quantitative inspection technology that is non-destructive and non-invasive to the package being tested. This technology requires no sample preparation and performs leak detection based on the basic principles of physics. The VeriPac 465 is an ASTM approved, FDA recognized package integrity testing method which is based on vacuum decay leak test method (F2338). This test method was developed using VeriPac leak test instruments. Unique test cycles, pneumatic controls and processing algorithms are certain features of VeriPac 465 system that make it the foremost vacuum-based leak test for parenteral products.

This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, results are non-subjective and testing is non-destructive to both product and package.

Technology overview

The test begins by connecting VeriPac 465 leak tester to a chamber that is specially designed to contain the package to be tested. Vacuum is then applied to the test chamber in which the package is placed. Using dual transducer technology, the test chamber is monitored for both- level of vacuum and 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. VeriPac 465 technology reduces the baseline measurement for good samples and amplifies the test result for defective samples. This technology is geared towards detecting leaks in the MALL range for parenteral packaging and can also be applied to flexible and semi flexible package formats

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)

Benefits of VeriPac 465

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.002 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard