Autoinjector Electrode-Based Leak Detection Without Disassembly
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Solution Overview
Problem
Current methods for testing container closure integrity in autoinjectors are inefficient and require disassembly, posing challenges for leak detection and patient safety in medical packaging.
Innovation Solution
An autoinjector device with a housing containing a plurality of electrodes and electrical contacts allows for non-invasive high voltage leak detection by applying voltage and measuring current, enabling the determination of container integrity without disassembly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional HVLD inspection methods are used, then leak detection capability is achieved, but disassembly of the autoinjector is required
Solution Approach 1:
The electrodes are nested within the housing structure, with at least one electrode positioned inside the housing and another electrode on the outer surface of the housing. This nested arrangement allows the testing system to be integrated within the autoinjector assembly, enabling leak detection without disassembly while maintaining the capability to detect leaks through the housing walls.
Solution Approach 2:
The housing acts as an intermediary structure that contains the electrodes and provides a testing chamber. The housing mediates between the electrodes and the medication container, allowing electrical signals to pass through the housing walls to detect leaks in the container without requiring direct access to the container or disassembly of the autoinjector.
2Illumination intensity
If the plastic housing includes a window feature for visibility, then product visibility is improved, but access for CCI testing is blocked
Solution Approach 1:
The housing serves as an intermediary testing chamber that eliminates the need for direct visual access to the medication container. By placing electrodes within the housing and using the housing itself as part of the testing structure, CCI testing can be performed through the housing walls without requiring windows or openings that would compromise the sterile barrier or packaging integrity.
Solution Approach 2:
The invention replaces the need for mechanical access (windows, openings) with an electrical field-based testing method. Instead of requiring physical access to the container for visual inspection or direct probing, the system uses electrical signals that can penetrate the housing walls to detect leaks, substituting mechanical access requirements with electromagnetic field interactions.
3Ease of operation
If electrodes are positioned inside the housing, then non-invasive testing is enabled, but electrode arrangement complexity increases
Solution Approach 1:
The housing serves multiple functions: it provides structural protection for the medication container, maintains the sterile barrier, and simultaneously acts as part of the testing structure by containing the electrodes and serving as one of the testing surfaces. This multi-functionality reduces overall system complexity despite the internal electrode positioning, as the housing structure is utilized for both protection and testing purposes.
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
This solution provides a reliable and efficient method for testing the integrity of pre-filled syringes and cartridges within autoinjectors, enhancing patient safety by allowing for leak detection without disassembly, thus improving the efficiency of container closure integrity testing.
Implementation Method 1
The HVLD detection method operates on the principles of electrical resistance and capacitance. If the package has a leak, the electrical resistance of the package walls is reduced, and voltage will conduct through the package.
Implementation Method 2
The HVLD detection method operates on the principles of electrical resistance and capacitance.
Implementation Method 3
If the package has a leak, the electrical resistance of the package walls is reduced, and voltage will conduct through the package.
Data Source
AI summary
A device and method for testing and inspecting the integrity of an autoinjector device is disclosed. The autoinjector devices includes a medication container, a housing that receives the medication container, the housing including a plurality of electrodes arranged circumferentially relative to the medication container, and a plurality of electrical contacts corresponding to the plurality of electrodes and in electrical communication therewith, the electrical contacts being accessible from the exterior of the autoinjector device, wherein a circuit between at least one pair of electrodes, measured at the electrical contacts, indicates a defect in the medication container. A method of testing the integrity of the autoinjector device is also disclose, wherein a voltage is applied to the electrical contacts in order to determine the integrity of the medication container in the autoinjector device. Accordingly, defects in the pre-packaged medication container in the autoinjector device may be detected.