Article | September 13, 2025

Optimize Packaging Systems For Distribution Integrity: Standards, Testing, And Best Practices

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Ensuring the safe and reliable transport of medical devices is critical to preserving product integrity and protecting patient safety. Every stage of distribution exposes devices to potential hazards — from shock, vibration, and compression to temperature and humidity fluctuations — making robust packaging systems essential. The packaging not only provides physical protection but also serves as a sterile barrier against contaminants, safeguarding device performance until the point of use.

To achieve this, manufacturers must rely on established ASTM and ISTA guidance to design and validate packaging strategies that meet stringent regulatory requirements. Success depends on carefully scoping distribution projects, selecting appropriate testing standards, understanding the unique properties of different packaging types, and defining distribution cycles that accurately reflect real-world conditions.

By proactively addressing these factors, medical device manufacturers can strengthen packaging system integrity, ensure regulatory compliance, and deliver devices that arrive safely and perform as intended.

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