Perforated Tamper-Evident Label for Needle Assembly Packaging
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Solution Overview
Problem
Existing tamper-proof packaging solutions for medical needle assemblies, particularly those using hard case packaging, lack reliable indicators of opening events and are not compatible with automated packaging processes, making them prone to user errors and sterility breaches.
Innovation Solution
A hard-shell packaging product with a case and cap, sealed by an adhesive label featuring perforated lines angled at 20-40 degrees relative to the gap between the cap and case, providing visible tear marks upon opening and ensuring irreversible tamper evidence, while maintaining compatibility with automated machinery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If a hard case packaging product with cap and case is used, then compatibility with automated packaging processes is improved, but reliability of tamper-proof indication deteriorates
Solution Approach 1:
The label is divided into multiple functional zones: a first zone extending from the cap edge across the gap, a second zone extending from the case edge across the gap, and a third zone connecting these zones. This segmentation allows each zone to serve specific tamper-indication functions while maintaining overall label integrity and automated applicability.
Solution Approach 2:
Different regions of the label have different properties: the first and second zones have tear-resistant properties with specific tensile strength characteristics, while the third zone has tear-prone properties that facilitate visible tearing. This local differentiation ensures reliable tamper indication while maintaining compatibility with automated packaging processes.
2Reliability
If the label is made tear-resistant to prevent accidental opening, then reliability of sterility protection is improved, but ease of operation for legitimate opening deteriorates
Solution Approach 1:
The label is segmented into tear-resistant zones (first and second zones extending from cap and case edges) and a tear-prone zone (third zone connecting the first and second zones). This allows the label to resist accidental tearing while enabling controlled opening at the designated third zone location.
Solution Approach 2:
The third zone acts as an intermediary element between the first and second zones, providing a controlled failure point that facilitates legitimate opening while maintaining the tear-resistant properties of the first and second zones that prevent accidental opening.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution provides a highly visible and irreversible indication of opening, ensuring product sterility and compatibility with automated packaging processes, enhancing user confidence and operational efficiency.
Implementation Method 1
an adhesive label. The adhesive label is affixed to an outer face of the enclosure
Implementation Method 2
The plurality of perforation lines was found to provide an effective visual indication of a prior opening event or attempt to re-close the packaging, by a presence of tear marks
Data Source
AI summary
The present disclosure pertains to a packaged needle assembly product (100) comprising: a hard-shell packaging product comprising a case (2) and a cap (3) arranged in an assembled configuration forming an enclosure for the needle assembly. and an adhesive label (13) affixed to an outer face of the enclosure, wherein the label extends across at least a portion of a circumferential gap (g) between the cap and the case thereby sealing the hard-shell packaging product (1). The label includes a perforated section that comprises a plurality of perforation lines 51 that cross the gap under an angle from a first end that terminates at or beyond the edge of the cap to a second end that terminates at or beyond the edge of the case across the gap.