Pharmaceutical Vessel Closure with Segmented RFID for Tamper Evidence

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Solution Overview

Problem

Current closure arrangements for pharmaceutical vessels lack a reliable and permanent method to indicate the first use status, which is essential for tamper-evidence, as existing solutions do not provide a lasting effect on the memory unit when the overcap is removed.

Innovation Solution

The closure arrangement includes an operative connection between the memory unit and both the overcap and closure stopper, ensuring a lasting effect on the memory unit when the overcap is torn off, allowing for permanent detection of the first-use status through a wireless-readable mechanism, such as an RFID or NFC tag, which can be irreversibly influenced by tearing or destruction, ensuring the status is not reversible.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the overcap is removed to indicate first use, then the tamper-evident function is achieved, but the memory unit cannot reliably record the status permanently

Engineering Contradiction:
Improvereliability of first-use status indicationVSAvoidloss of first-use status information
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The memory unit is segmented into two separate parts: one part remains connected to the closure stopper (staying on the vessel), and the other part is connected to the overcap (removed when overcap is torn off). This segmentation ensures that at least one part of the memory unit remains to preserve the first-use status information, resolving the contradiction between achieving tamper evidence and maintaining reliable status recording.

Inventive Principle:
Principle #1Segmentation

2Reliability

If the memory unit is connected only to the closure stopper, then the status can be recorded, but the connection cannot detect overcap removal

Engineering Contradiction:
Improvedetection of overcap removalVSAvoidcomplexity of connection system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The memory unit is divided into two parts with different connection points: one part connected to the closure stopper and another part connected to the overcap. When the overcap is removed, the separation of these two parts provides detectable evidence of removal while maintaining the connection to the closure stopper for status recording. This segmentation approach achieves detection capability without requiring complex additional mechanisms.

Inventive Principle:
Principle #1Segmentation

3Reliability

If the memory unit is made irreversible upon overcap removal, then tamper evidence is enhanced, but the system becomes more complex

Engineering Contradiction:
Improveirreversibility of first-use statusVSAvoidcomplexity of irreversible mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The irreversible effect is achieved through simple segmentation: the memory unit is torn into two parts upon overcap removal, with one part remaining on the vessel. This physical separation inherently creates an irreversible state that is easy to detect (the memory unit no longer functions as a complete unit) without requiring complex irreversible mechanisms or additional components.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS12122574B2Closure arrangement for a vessel containing a pharmaceutical substance
Publication Date: 2024.10.22 DATWYLER PHARMA PACKAGING BELGIUM
  • US12122574B2 patent drawing
  • US12122574B2 patent drawing
  • US12122574B2 patent drawing

AI summary

A closure arrangement for a vessel containing a pharmaceutical substance, having a stopper, a metal cap, for securing the stopper on the vessel, and an overcap made of plastic, wherein, for the purpose of identifying contents of the vessel, a wirelessly readable, electrical memory unit is connected to the closure arrangement. In order for a closure arrangement of the type in question to be improved further, in particular in respect of tamper-evident sealing the memory unit is operatively connected both to the overcap and to the stopper, and the operative connection has a lasting effect on the memory unit when the overcap is torn off.