Closure Cap Spike Insertion Seal Integrity
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Solution Overview
Problem
Existing closure cap systems for BFS containers used in enteral nutrition are cumbersome when connecting a flexible line's spike for transferring nutrient solutions, leading to potential leakage and handling difficulties.
Innovation Solution
A closure cap design featuring an annular body that surrounds the spike, forming a seal and ensuring the cap remains closed during spike insertion, combined with a tamper-evident break-off part and gripping wings for improved handling and aseptic closure, and a beaded-over rim for membrane retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a known closure cap with a slit membrane is used, then the spike can be inserted to transfer nutrient solution, but the membrane may not be sealed properly during puncture causing leakage
Solution Approach 1:
The closure cap is divided into functionally distinct parts: a pierceable membrane for controlled puncture, an annular sealing body for reliable sealing, and a break-off part for tamper evidence. This segmentation allows each component to perform its specific function optimally without interfering with others.
Solution Approach 2:
The annular sealing body acts as an intermediary element between the spike and the container contents. It provides a reliable sealing interface that ensures proper sealing during spike insertion, mediating between the mechanical action of the spike and the requirement for leak-free containment.
2Device complexity
If a simple membrane closure is used, then the structure is simple, but handling during spike connection is cumbersome and unsafe
Solution Approach 1:
The break-off part is designed to be removed before spike insertion, providing preliminary action that prepares the closure cap for safe and easy handling during the subsequent spike connection process. This preliminary removal of the protective cover enables proper grip and orientation.
Solution Approach 2:
The break-off part serves as a visual indicator through its presence or absence, providing color-coded or state-coded information about the sealing status and tamper evidence, making the system's state immediately recognizable without complex indicators.
3Ease of manufacture
If no tamper-evident feature is included, then the manufacturing is simpler, but handling safety is reduced
Solution Approach 1:
The closure cap includes a separable break-off part that can be easily manufactured as a distinct component. This segmentation allows the tamper-evident feature to be produced through simple injection molding without complicating the overall manufacturing process.
Solution Approach 2:
The break-off part is designed as a disposable, single-use component that provides tamper evidence through its intentional destruction during normal use. This approach provides robust tamper protection using a simple, inexpensive element that is discarded after serving its protective function.
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
Simplifies the connection process, prevents leakage by ensuring a secure seal, and enhances handling safety and efficiency during spike insertion, while allowing for cost-effective mass production using plastics injection molding.
Implementation Method 1
The wall thickness of the annular body may be so sized, or the material of which the annular body is composed may be so selected, that the annular body is endowed with a certain elasticity. The annular body which surrounds the spike and makes a seal as it does so is able to deform slightly when the spike is inserted and the spike is thus surrounded by the body with a seal made.
Implementation Method 2
The withdrawal part has a connecting part for a spike of a flexible line of a transfer device and a closing-off part having a pierceable membrane for closing-off the recess in the connecting part.
Data Source
AI summary
The closure cap according to the invention for a container for receiving liquids, and in particular a BFS container for receiving an enteral nutrient solution, has a cover part and a rim part, with a withdrawal part for the withdrawal of a liquid, and in particular the enteral nutrient solution, being arranged in the cover part. Basically, the closure cap according to the invention may also comprise, as well as the withdrawal part, an injection part for the injection of a medicinal liquid into the enteral nutrient solution. The withdrawal part of the closure cap according to the invention has a connecting part for a spike of a flexible line of a transfer device and a closing-off part having a pierceable membrane for closing-off the recess in the connecting part.