The work aims to analyze the challenges confronting the medical device packaging industry, establish a scientific validation system, and evaluate the potential of technological applications to drive the industry toward a more efficient and secure validation paradigm. By integrating case analysis, standard interpretation, and process construction with industry practice and frontier technology exploration, a full-process packaging validation framework grounded in risk management is proposed. Firstly, the medical device recall incidents that have occurred in the past five years are analyzed, revealing the practical warning significance of packaging defects as a core risk point. Secondly, an in-depth analysis of the latest revisions to international mainstream sterility testing and packaging verification standards in recent years and the new challenges posed by them to compliance is provided. Thirdly, the whole process packaging verification framework from risk assessment, material selection to process confirmation and performance testing is systematically constructed, emphasizing the importance of quality management throughout the life cycle of aseptic packaging systems. Finally, focusing on emerging technological innovations, the application prospects of cutting-edge technologies such as rapid microbial detection, advanced barrier performance testing, and digital process monitoring are discussed in improving verification efficiency and reliability. The study demonstrates that packaging failure risks are prominent, necessitating strengthened lifecycle validation. Establishing a risk management-based validation system and promoting technology integration and standardization constitute critical pathways for industry development hold significant implications for enhancing medical device safety and quality.
Key words
sterile medical devices /
failure mode analysis /
packaging verification /
risk management /
full-process validation
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References
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