Multi-Chamber Flexible Bag for In-Bag Pharmaceutical Reconstitution
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Solution Overview
Problem
Existing methods for handling lyophilized pharmaceutical products require multiple manipulation steps and expose healthcare workers to potential hazards during reconstitution and administration, leading to increased risks and compliance challenges.
Innovation Solution
A multi-chamber flexible bag is used for lyophilizing and storing pharmaceutical products, allowing reconstitution within the same bag, reducing handling and minimizing exposure risks through a breakable seal for mixing lyophilized and reconstituting solutions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple manipulation steps are used for handling lyophilized pharmaceutical products, then the reconstitution process can be completed, but the exposure risk to healthcare workers and handling errors increase
Solution Approach 1:
The patent combines the lyophilized pharmaceutical product and reconstituting solution into a single integrated bag system, eliminating the need for separate handling steps. The breakable seal allows the chambers to remain separated during storage and transport, then fuse together during reconstitution, reducing the number of manipulation steps while maintaining reliability.
Solution Approach 2:
The bag is divided into multiple sealed chambers - one containing the lyophilized product and another containing the reconstituting solution. This segmentation allows each component to be stored separately under appropriate conditions while maintaining the ability to combine them safely when needed, reducing exposure risk.
2Loss of time
If the pharmaceutical product is stored and reconstituted in the same bag, then handling time is reduced, but the bag structure becomes more complex
Solution Approach 1:
The patent merges the storage and reconstitution functions into a single bag system. The lyophilized product and reconstituting solution are contained in the same bag in separate chambers, allowing reconstitution to occur in-situ without transferring components between containers, thereby reducing handling time.
Solution Approach 2:
The bag structure is segmented into multiple sealed chambers separated by breakable seals. This segmentation allows the bag to function as both a storage container and a reconstitution vessel, eliminating the need for external manipulation steps while maintaining a manageable structure.
3Reliability
If a breakable seal is used to separate chambers, then the bag remains sealed during storage, but the seal must be strong enough to withstand handling
Solution Approach 1:
The breakable seal is designed with non-uniform properties - it is stronger in most areas to maintain integrity during storage and handling, but contains a localized weak point or designed failure point that allows controlled breaking when needed for reconstitution. This local quality variation resolves the contradiction between seal strength and ease of breaking.
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 solution reduces reconstitution time, minimizes errors, and enhances compliance with regulations by ensuring a self-contained, ready-to-administer product that minimizes accidental exposure and handling hazards for healthcare workers.
Implementation Method 1
Lyophilization is the process of removing the liquid portion from a frozen sample by converting the liquid portion directly into vapor without the intermediate formation of the liquid. The main steps of lyophilizing are freezing (from a liquid state to a solid state), primary drying (sublimation), and secondary drying (with high temperatures for removing the non-frozen liquid).
Implementation Method 2
The main steps of lyophilizing are freezing (from a liquid state to a solid state), primary drying (sublimation), and secondary drying (with high temperatures for removing the non-frozen liquid).
Data Source
AI summary
A flexible pharmaceutical bag includes a first chamber holding a lyophilized pharmaceutical product, a second chamber separated from the first chamber, and a third chamber separated from one of the first and second chambers. The second chamber holds a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. The third chamber holds a solution. The flexible pharmaceutical bag includes a seal disposed between the first chamber and the second chamber. The seal separates and seals the first chamber from the second chamber. The flexible pharmaceutical bag includes a first port attached to the first chamber. The first port introduces a pharmaceutical product into the first chamber and allows passage of water vapor from the pharmaceutical product during lyophilization of the pharmaceutical product. The third chamber is separated from one of the first and second chambers by a valve.