Tamper-Evident Syringe Closure Assembly with Rotational Support
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The challenge lies in maintaining the sterility and integrity of pre-filled syringes during handling, storage, transport, and distribution, as well as preventing unauthorized access and tampering, while ensuring accurate tracking and efficient connection to syringes without direct handling of the closure.
Innovation Solution
A tamper-evident closure assembly with a support system that includes a rotational attachment mechanism and tracking system using identifying codes, allowing for secure connection to syringes without direct handling and enabling monitoring of the syringe's distribution route.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a closure assembly is designed to be securely attached to a syringe, then the sterility and integrity of the syringe are maintained, but the complexity of the attachment mechanism increases
Solution Approach 1:
The closure assembly is divided into separate functional components: a closure body for sealing the syringe tip, a support structure for positioning, and an attachment mechanism with rotational elements. This segmentation allows each component to perform its specific function while maintaining overall simplicity and reliability in preserving sterility.
Solution Approach 2:
A support structure acts as an intermediary between the closure assembly and the syringe, providing a stable interface for attachment. This intermediary component facilitates secure connection without requiring direct handling of the closure itself, thereby maintaining sterility while simplifying the attachment process.
2Ease of operation
If the closure assembly requires direct handling for attachment, then the operation is simple, but the risk of contamination increases
Solution Approach 1:
The support structure serves as a sterile intermediary that allows the syringe to be attached to the closure assembly without direct human contact with the closure surfaces. The support structure can be handled while maintaining sterility, and the syringe rotates within this supported framework to achieve attachment, thereby eliminating contamination risk while keeping the operation simple.
Solution Approach 2:
The closure assembly is designed to be self-aligning and self-attaching through its support structure and rotational mechanism. The syringe automatically finds the correct orientation and engages with the closure without requiring manual manipulation or handling of the closure components, thereby maintaining sterility while ensuring ease of operation.
3Adaptability or versatility
If multiple people handle the syringe during delivery and storage, then the distribution process is flexible, but the chance of contamination and tampering increases
Solution Approach 1:
The tamper-evident feature provides feedback about the integrity of the syringe-closure assembly. If the assembly has been opened or tampered with, the tamper-evident mechanism changes state (e.g., a marker moves or a seal breaks), providing immediate indication of compromise. This feedback mechanism allows the system to maintain security while allowing flexible distribution, as anyone can see if the syringe has been tampered with without restricting who can handle it.
Solution Approach 2:
The tamper-evident feature utilizes visual indicators such as color changes or visible marker movements to show whether the syringe-closure assembly has been opened or tampered with. This visual feedback mechanism allows for easy detection of contamination or tampering while maintaining distribution flexibility, as the indicator simply provides information without restricting handling.
4Loss of information
If the closure assembly includes tracking codes, then the monitoring of distribution route is improved, but the device complexity increases
Solution Approach 1:
Instead of embedding complex electronic tracking systems in the closure assembly, simple visual or physical identifiers (such as barcodes, QR codes, or numbered markers) are placed on the closure and support structure. These simple copies of identification information can be easily read and recorded during distribution, providing tracking capability without adding significant complexity to the device itself.
Data Source
AI summary
A system for tracking a multi-component, tamper evident closure assembly for a pre-filled syringe along a distribution route, including a predetermined code applied to each of a plurality of components of the same closure assembly and comprising electronically readable coded indicia, is structured to identify and distinguish each of a plurality of closure assemblies from one another. A reading and recording of predetermined code for each closure assembly along the distribution route is accomplished. The location at which tampering of a closure assembly has occurred along the corresponding distribution route can be accomplished by reading the coded indicia segments on any of detached or assembled ones of the plurality of originally assembled components of the same closure assembly.