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<p>Seal integrity (Si) failures are critical nonconformities that can compromise product efficacy and lead to a loss of customer confidence. The current study compares recognized standardized tests for measuring Si and proposes plausible remediations for related failures in medical product packaging. A meta-analysis was conducted on seal-related quality “reason for recall” data collected from three United States FDA databases. Standards for Si testing from the United States Pharmacopeia (USP), American Society for Testing and Materials (ASTM), and the International Organization for Standardization (ISO) were summarized and compared to identify areas of overlap, differences, and potential gaps. Between January 2019 and January 2025, the US FDA recalled 27,799 medical products, 791 of which were Si-related, approximately 1–4% of all product IDs recalled per year. Medical devices accounted for 96.7% of the product IDs recalled due to Si. The packaging type most impacted was pouches or bags (74.8%), followed by trays or kits (10.0%). Regulatory authorities utilize ISO 11607, the USP &lt; 1207 &gt; and its derivative monographs, which define deterministic and probabilistic leak test methods, as well as ASTM D3078, F88, F1886, F1929, F2338, and F2391as recognized tests for container closure integrity testing. One major challenge in establishing tolerances for Si is balancing the need for a strong, tamper-resistant seal with the risks associated with excessive seal force. This review highlights the continued reliance on probabilistic testing methods within the medical device industry. It emphasizes the potential benefits of the broader adoption of innovative options for early detection of seal-related failures, ultimately preventing future recalls.</p> Graphical abstract <p></p>

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Metadata analysis for packaging seal integrity relationships to medicinal product recalls

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月15日

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  • Libby Lungren,
  • Mercy A. Okezue

摘要

Seal integrity (Si) failures are critical nonconformities that can compromise product efficacy and lead to a loss of customer confidence. The current study compares recognized standardized tests for measuring Si and proposes plausible remediations for related failures in medical product packaging. A meta-analysis was conducted on seal-related quality “reason for recall” data collected from three United States FDA databases. Standards for Si testing from the United States Pharmacopeia (USP), American Society for Testing and Materials (ASTM), and the International Organization for Standardization (ISO) were summarized and compared to identify areas of overlap, differences, and potential gaps. Between January 2019 and January 2025, the US FDA recalled 27,799 medical products, 791 of which were Si-related, approximately 1–4% of all product IDs recalled per year. Medical devices accounted for 96.7% of the product IDs recalled due to Si. The packaging type most impacted was pouches or bags (74.8%), followed by trays or kits (10.0%). Regulatory authorities utilize ISO 11607, the USP < 1207 > and its derivative monographs, which define deterministic and probabilistic leak test methods, as well as ASTM D3078, F88, F1886, F1929, F2338, and F2391as recognized tests for container closure integrity testing. One major challenge in establishing tolerances for Si is balancing the need for a strong, tamper-resistant seal with the risks associated with excessive seal force. This review highlights the continued reliance on probabilistic testing methods within the medical device industry. It emphasizes the potential benefits of the broader adoption of innovative options for early detection of seal-related failures, ultimately preventing future recalls.

Graphical abstract