Best practices for identifying packaging defects and understanding the impact of human factors on seal integrity to ensure patient safety and product sterility.
Human factors have become one of the most critical considerations in medical device packaging validation, sterile barrier design, and the overall safety of medical devices. While packaging materials and sealing technologies continue to advance, the human element remains a major source of variability, risk, and potential failure. Research shows that humandevice interaction, cognitive load, and […]
Visual inspection is a critical, non‑destructive first line of defense for medical pouch seal integrity, guided by ASTM F1886. It catches visible defects early, informs root‑cause analysis, and should be part of a layered testing strategy to protect patients and reduce recall risk. Importance of Visual Inspection Visual inspection provides immediate, low‑cost detection of gross […]
