Vial Adapter Double Membrane Airflow Contamination Barrier
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Solution Overview
Problem
Existing drug mixing systems, such as the Tevadaptor, do not effectively prevent the passage of air-borne particles, microorganisms, and aerosols into the vial adapter assembly while allowing air passage, which poses risks during the handling of hazardous intravenous drugs.
Innovation Solution
A vial adapter assembly with a double membrane system, where the first and second hydrophobic membranes are parallel and separated by a gap, allowing air passage while preventing the passage of liquids, air-borne particles, microorganisms, and aerosols, supported by a membrane support member with vent holes and a carbon cloth filter to prevent toxic vapors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a single membrane is used to allow air passage, then air can flow freely into the vial adapter assembly, but air-borne particles, microorganisms, and aerosols can also pass through
Solution Approach 1:
The single membrane is divided into multiple membranes (first membrane and second membrane) separated by a gap. Each membrane provides a layer of protection, and the segmented structure allows air to pass through while blocking contaminants that would otherwise penetrate a single membrane layer.
Solution Approach 2:
The invention introduces a spatial dimension by creating a gap between two membranes rather than using a single membrane. This gap creates a physical barrier that disrupts the passage of aerosols and particles while maintaining air flow, effectively adding a dimensional layer of protection.
2Object-affected harmful factors
If a double membrane system with gap is implemented, then air passage is maintained while preventing contaminant entry, but the device complexity increases
Solution Approach 1:
The membrane assembly is integrated within the existing vial adapter assembly structure. The first and second membranes are nested within the adapter body, with the membrane support member providing structural containment. This nesting approach allows the complex double membrane system to be incorporated without proportionally increasing overall device complexity.
3Object-affected harmful factors
If hydrophobic membranes are used to block liquid passage, then liquid and aerosol are prevented from passing through, but the membrane structure requires additional support
Solution Approach 1:
The membrane support member acts as an intermediary structure between the hydrophobic membranes and the vial adapter assembly. It provides mechanical support to the delicate membranes, distributing stresses and preventing membrane collapse or deformation while allowing the membranes to maintain their hydrophobic barrier 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
The double membrane system ensures safe handling of hazardous drugs by preventing the entry of contaminants while allowing air passage, enhancing the safety and efficacy of the drug mixing process.
Implementation Method 1
The first and second membranes may be hydrophobic and generally parallel to one another
Data Source
AI summary
Apparatus for use in a drug mixing system including a vial adapter assembly including a main body element having a vial receiving portion and a needle puncturable port, the main body element including an axial hollow tubular portion which is in fluid flow engagement with a bore of a vial puncturing spike, the main body element further including a membrane support surface that supports a first membrane which is in fluid flow engagement with the vial puncturing spike via the bore and via a recess formed in an intermediate portion of the main body element, and a second membrane supported by a membrane support member and separated by a gap from the first membrane.