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Life-saving Pharmaceutical products, medications, particularly those in the realm of high-risk biologics and complex drug delivery systems, often require stringent storage and transportation conditions. This critical journey, known as the cold chain, ensures these temperature-sensitive drugs reach patients with their potency and sterility intact.

Maintaining a consistent cold environment throughout the supply chain is undeniably crucial. However, temperature control alone isn't enough to guarantee a drug's efficacy. Even the most minute breach in a container's integrity can have catastrophic consequences. Moisture ingress or exposure to external contaminants can compromise the sterility of the drug, rendering it ineffective or even hazardous to patients. Container closure integrity testing is crucial for this class of pharmaceuticals.

Container Closure Integrity Testing using Helium Leak Detection

Helium leak detection technology has revolutionized container closure integrity testing (CCIT) by providing highly sensitive and precise detection of leaks. Helium leak detection can be understood as the process of identifying leaks in any closed or sealed system with the help of helium gas and measuring its concentration as it escapes due to leakage. Common applications of helium leak testing include pre-filled syringes, vials, cold form blister packs, foil pouches and many other package formats. This technology can precisely determine integrity between specific primary container closure system components, making it an ideal choice for testing the integrity of pharmaceutical products.

This method utilizes helium gas, which has exceptional properties that make it an ideal tracer for leak detection purposes. By harnessing the unique characteristics of helium, manufacturers can perform comprehensive testing to identify even the smallest leaks, enhancing the overall integrity of vial packaging.

The LT150 and LT80 cold chain helium mass spectrometers can test containers correctly in cold chain and cryogenic conditions and create 21-CFR Part 11-compliant reports in real-time for helium testing. The proprietary algorithm that supports these systems provide data on flow rate, gas concentration, and other variables. This helps developers in determining the exact size of a leak, down to less than 6 x 10-6-millibars-liters per second helium leak rate, which has become the industry standard for maintaining a sterile barrier.

Technology Overview

The test starts by introducing helium into the package, which is then subjected to a vacuum. The quantity of helium that escapes from the package is then measured using a helium leak detector, providing a quantitative measure known as the leak rate. In addition to leak testing, helium leak detection technology has proven to be effective for tasks such as package design, failure analysis, tooling qualification, packaging line setup and validation, and monitoring product quality. The use of helium leak detection in accordance with ASTM F2391 and USP 1207 is a widely accepted and extensively utilized method in the pharmaceutical industry.

Benefits of Helium Leak Detection

• Leaks can be measured and identified with a high degree of sensitivity.
• Because of the inert properties of the helium, no effect on the materials under test.
• Dry and temperature-independent testing procedure.
• Reduces the cost and overall processing time, since helium leak testing has a faster cycle time
• With a high-speed vacuum approach, the leak test limit can be set to 1 x 10-10 mbar L/sec, allowing for unique comparisons across components, materials, formats, and manufacturing characteristics.