Tamper-Evident Syringe Closure Assembly with RFID Tracking
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Solution Overview
Problem
The challenge lies in maintaining the sterility and integrity of pre-filled syringes during handling, storage, transport, and use, as well as preventing unauthorized access and tampering, while ensuring efficient and cost-effective manufacturing and tracking of syringe closure assemblies.
Innovation Solution
A closure assembly with a tamper-evident design and tracking system, featuring a syringe cap and end cap member that restricts fluid flow and includes identifying codes for tracking, which can be electronically or visually read, and a support base for secure attachment without direct handling, utilizing RFID structures for tamper detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple people handle syringes during delivery and storage, then distribution and accessibility are improved, but contamination risk and tampering increase
Solution Approach 1:
A closure assembly with support base acts as an intermediary carrier between the syringe filling station and the patient administration point. The closure assembly includes a support base that holds the syringe in a fixed, upright position, eliminating the need for multiple people to handle the syringe body. This intermediary structure allows the syringe to be transported and stored without direct human contact, reducing contamination risk while maintaining distribution capability.
Solution Approach 2:
The closure assembly separates the syringe from direct human handling by extracting the syringe from manual operation and placing it in a fixed, upright position on the support base. The syringe is taken out of the handling process and secured in a sterile environment, allowing only the needle portion to be exposed for administration while the main body remains protected.
2Reliability
If closure assembly is designed for secure attachment without handling, then sterility is improved, but device complexity increases
Solution Approach 1:
The closure assembly is segmented into distinct functional components: a support base for fixed positioning, a closure member for sealing the discharge port, and a syringe cap for protecting the needle. Each component performs a specific function and can be independently manufactured and assembled, reducing overall complexity while maintaining the secure attachment and sterility benefits.
Solution Approach 2:
The support base serves multiple functions: it provides structural support for the syringe, maintains the syringe in an upright position, secures the syringe to prevent movement, and acts as a sterile barrier. This multi-functionality reduces the need for additional separate components, simplifying the overall device structure while maintaining reliability.
3Reliability
If tracking system with identifying codes is implemented, then tamper detection is improved, but manufacturing cost increases
Solution Approach 1:
Instead of using complex electronic tracking systems, the patent uses visual identifying codes (such as barcodes or printed numbers) on the closure assembly and syringe. These codes can be easily replicated during manufacturing using standard printing or labeling techniques, significantly reducing manufacturing cost while providing sufficient tamper detection capability through visual verification and tracking.
Data Source
AI summary
A system for tracking identifying and detecting a tamper evident closure assembly for a pre-filled syringe, as well as multiple components associated therewith, along various points of a distribution route, including the location where the syringe is being accessed. A predetermined identifying code is applied to each or predetermined ones of a plurality of components of the same closure assembly in the form of electronically, visually or optically readable coded indicia. Alternatively, the predetermined identifying code can be one or more RFID structures each disposed on a predetermined one of the multiple components. The predetermined identifying code enables one to determine the identity and distinguish each of a plurality of closure assemblies and their multiple components from one another. The occurrence of tampering with a closure assembly can be accomplished by reading, detecting and/or comparing the predetermined identifying code on any of the multiple components of a closure assembly.