As industries continue to advance their quality control practices, leak detection in packaging has become a critical focus area. The latest revision of the ASTM F2338-24 standard test method, officially recognised by the FDA as a deterministic, non-destructive method for container closure integrity testing(CCIT), marks a significant milestone, enhancing the standards for non-destructive leak detection in flexible, nonporous packaging. For its part, Oxipack played a key role in refining ASTM F2338-24 by advocating for flexible packaging, validating the 5 µm leak detection threshold, and demonstrating reproducibility through artificial leaks.
The ASTM F2338 standard, first introduced in 2003, has been the benchmark for non-destructive leak detection in packaging. However, as packaging technology evolved, gaps in the standard became apparent. Specifically, there was no dedicated guideline addressing vacuum decay testing for flexible, nonporous packaging—a critical need for the food, pharmaceutical, and medical industries.
With the 2024 revision, ASTM F2338-24 now explicitly acknowledges vacuum decay as a deterministic, reliable testing method for flexible packages containing gas or liquid and replaces probabilistic methods like blue dye and bubble testing. The updated standard highlights its capability to detect defects as small as 5 µm in diameter, offering unprecedented precision in leak detection. These refinements were validated through interlaboratory studies that demonstrated the robustness and reproducibility of the method.
Oxipack’s contribution to the revision
For more than five years, Oxipack has worked collaboratively with industry stakeholders, competitors, and regulatory experts to refine ASTM standards, ensuring they reflect the latest advancements in leak detection technology.
Our contributions have been instrumental in expanding the scope. By advocating for the inclusion of flexible packaging in the standard, Oxipack has helped ensure that vacuum decay testing is recognised as a viable method for a broader range of packaging types. We also established that all participating labs achieved the same level of accuracy. Our contributions helped reinforce confidence in the 5 µm leak detection threshold, setting a consistent industry benchmark for precision. Working with our competitors, we developed universal best practices for procedures to strengthen the reliability of vacuum decay as a non-destructive, deterministic test method.
The significance of vacuum decay testing
Traditional leak detection methods, such as bubble and dye testing, rely on probabilistic outcomes, leading to potential inconsistencies and false positives. In contrast, vacuum decay testing provides a deterministic approach, delivering repeatable and accurate results.
This technology ensures greater reliability. By eliminating subjectivity in leak detection, vacuum decay testing offers consistent and reproducible results. It also assists in improving operational efficiency. The non-invasive nature of vacuum decay testing allows manufacturers to test entire batches without damaging the packaging, reducing waste, and improving throughput.
Finally, there is enhanced product integrity. Ensuring airtight packaging is essential for maintaining product freshness, safety, and regulatory compliance, particularly in the food and pharmaceutical sectors.
Furthermore, vacuum decay testing aligns with USP <1207> Compliance. This mandates deterministic methods for CCIT. Specifically, USP<1207.1> lists vacuum decay as a preferred method and USP <1207.3> details its validation using artificial leaks.
The industry impact of ASTM F2338-24
The revised ASTM F2338-24 standard reflects the industry’s growing recognition of vacuum decay testing as the gold standard in leak detection. With its expanded scope and enhanced validation, manufacturers now have a clearly defined framework for implementing more reliable, sustainable, and cost-effective leak detection solutions.
For companies still relying on outdated methods, this revision presents an exciting opportunity to transition to vacuum decay testing. The cost savings, efficiency gains, and sustainability benefits make it an indispensable tool for any forward-thinking packaging operation.
Committing to innovation
Oxipack remains dedicated to advancing leak detection technologies and setting industry benchmarks. Our patented systems, which incorporate flexible membranes for optimised testing, continue to push the boundaries of accuracy and reliability.
The principles of ASTM F2338 align with the ISO 11607 standard’s requirements for ensuring sterile barrier system integrity in medical device packaging. Vacuum decay testing is a recognised method for detecting leaks in nonporous packages, making it a suitable approach for compliance with ISO11607. We therefore invite manufacturers to explore how our solutions can help them comply with ASTM F2338-24, streamline their quality control processes, and enhance their competitive edge.
As the industry moves towards higher standards of precision and efficiency, we are proud to have played a part in leading the way. The revised ASTM F2338-24 standard expands its scope to provide manufacturers with a clearer regulatory framework for implementing reliable and sustainable leak detection solutions.
The relevance of vacuum decay testing continues to grow, with ongoing developments indicating that DIN standards are expected to include vacuum decay as a recognised method for package integrity testing in the near future. Oxipack is actively participating in this process, contributing its expertise to ensure that vacuum decay testing meets the highest industry and regulatory standards. With our continued commitment to innovation and collaboration, we look forward to shaping the future of leak detection for years to come.
