Aseptic Sterilizing and Dispensing Kit for Field Environments
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Solution Overview
Problem
Current medical procedures for mixing and sterilizing medications often require sophisticated facilities like laminar flow hoods, making it impractical to perform these tasks in field environments, such as remote locations where access to these facilities is not available.
Innovation Solution
A convenience kit that includes a sealed plastic bag with a sterilizing filter component, allowing for sterilization and mixing of liquids within the bag, ensuring sterility by forcing all fluid pathways through a medical-grade filter, and enabling digital manipulation and capping of components for safe transport and use in uncontrolled environments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If medications are sterilized and mixed in a pharmacy using laminar flow hoods, then sterility and product quality are ensured, but the expense and inconvenience prohibit broader application in field environments
Solution Approach 1:
The system divides the sterilization and mixing process into separate functional components: a sealed bag system for containment, a filter component for sterilization, and a hub for fluid management. This segmentation allows each component to be optimized independently and assembled in a field-friendly manner without requiring a full laminar flow hood infrastructure.
Solution Approach 2:
The filter component acts as an intermediary between the non-sterile external environment and the sterile internal bag environment. By forcing all fluid pathways through this medical-grade filter, the system achieves sterility assurance without requiring the entire workspace to be sterile, thus enabling field use.
2Adaptability or versatility
If a sealed bag system with filter component is used for field sterilization, then sterility is maintained without laminar flow hood, but complex assembly and sealing procedures are required
Solution Approach 1:
The filter component is integrated directly with the hub assembly, combining the filtration function with the fluid distribution function in a single unit. This merging reduces the number of separate components that need to be assembled and handled in the field, simplifying the overall procedure while maintaining sterility.
Solution Approach 2:
The bag and filter component are pre-assembled and pre-sterilized as a unit before being shipped to the field location. This preliminary action eliminates the need for complex on-site sterilization procedures and reduces assembly complexity during field use, as the critical sterility-barrier components are already prepared and validated.
3Ease of operation
If multiple components are assembled outside the bag, then assembly is easier, but sterility cannot be ensured without laminar flow hood
Solution Approach 1:
The hub and filter component are nested within the sealed bag, creating a hierarchical containment structure. This nesting allows the critical sterility-maintaining components to be assembled and sealed together as a single unit, ensuring that once the bag is sealed, all subsequent manipulations can occur outside the sterile field without compromising sterility.
Solution Approach 2:
The system applies sterility requirements locally to only the necessary components (bag, filter, hub) rather than requiring the entire assembly process to occur in a sterile environment. By concentrating the sterility-critical elements within the sealed bag system, the invention enables easier assembly outside the bag while maintaining sterility where it matters most.
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 kit provides a sterile and efficient method for mixing and dispensing medications in field environments, reducing contamination risks and simplifying procedures, while maintaining product sterility until the bag is opened, thus overcoming the limitations of traditional laminar flow hood reliance.
Implementation Method 1
a filter component to be affixed to the bag... providing a sterilizing fluid pathway into the bag
Data Source
AI summary
A convenience kit for sterilizing and delivering liquids into the safety of a sterile environment inside a plastic bag (which can be disposed in a field environment) wherein a so sterilized liquid is dispensed into a vessel which is capped and sealed before removal from the bag. The convenience kit can be provided in a solitary format or, as a subkit combined with other associated items in a more inclusive convenience kit. In short, convenience kits made according to the present invention provide opportunity for accomplishing an aseptic liquid sterilizing transfer, a task which is commonly associated with on-hand capability of a laminar flow hood, in field environments and other areas which are remote from facilities having laminar flow hoods.