Shelf life is supported by accelerated aging and real-time aging studies, often per ASTM F1980, that demonstrate package integrity and product performance over time. Accelerated aging uses elevated temperature and the Arrhenius-based Q10 approach to simulate time, but real-time aging data must follow to confirm the claimed date. Studies typically cover sterile barrier integrity (ISO 11607 with tests such as seal strength and dye penetration), product functionality and, for some devices, material degradation. The shelf life claim on the label must be supported by these studies in the technical documentation.

Why it matters

Shelf-life claims appear in labeling and must be supported by valid data. Extension studies are common as real-time data accumulates.

Common pitfalls

•A common pitfall is relying solely on accelerated aging data without initiating or completing real-time aging studies, which are crucial for conclusive shelf life determination.
•Manufacturers sometimes fail to consider the impact of packaging degradation on device sterility or functionality throughout the claimed shelf life.
•Another mistake is not establishing a clear, scientifically sound justification for the chosen accelerated aging conditions, potentially leading to invalid shelf life claims.
•Inadequate sample sizes for aging studies can lead to statistically unreliable data, making it difficult to defend shelf life claims during regulatory audits.
•Failing to re-evaluate shelf life after design changes or material substitutions can result in non-compliant products on the market.

Sources

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