Deterministic Nondestructive Seal Integrity Testing For Health Care Packaging

Ensuring the sterility of medical packaging is critical to patient safety and infection prevention. Healthcare packaging formats, such as pouches, trays, and form-fill-seal blisters, must maintain integrity from sterilization through the point of use. Traditional probabilistic methods like dye penetration and bubble emission often fall short due to subjectivity and limited sensitivity, increasing the risk of false negatives. Deterministic, non-destructive technologies such as Vacuum Decay and Airborne Ultrasound offer validated, quantitative solutions that comply with ISO 11607 and FDA consensus standards. These methods provide repeatable, statistically significant results while preserving package integrity, making them ideal for high-risk applications. By adopting scientifically sound inspection strategies, manufacturers can reduce healthcare-associated infections and uphold stringent quality standards.

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