Multi-Chamber Flexible Bag With Breakable Seal for In-Bag 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 issues.
Innovation Solution
A multi-chamber flexible bag is used for lyophilizing and storing pharmaceutical products, with a separate chamber for a reconstituting solution, allowing in-bag mixing and administration without additional handling, using materials that withstand autoclave sterilization and lyophilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple manipulation steps are used for handling lyophilized pharmaceutical products, then reconstitution can be performed, but healthcare workers are exposed to potential hazards and compliance risks increase
Solution Approach 1:
The system divides the pharmaceutical product into separate compartments: a first chamber for the lyophilized pharmaceutical product and a second chamber for the reconstituting solution. This segmentation isolates the hazardous lyophilized product from healthcare workers while maintaining functionality, as the chambers are separated by a breakable seal that can be easily breached when needed.
Solution Approach 2:
The patent implements a nested configuration where the first and second chambers are contained within a single flexible bag structure. The breakable seal integrates into the bag wall, creating a compact nested arrangement that maintains safety isolation while enabling simple activation through pressure application.
2Productivity
If multiple manipulation steps are used for reconstitution, then pharmaceutical products can be prepared, but reconstitution time increases
Solution Approach 1:
The reconstituting solution is pre-loaded into the second chamber during manufacturing, eliminating the need for healthcare workers to measure or prepare the solution separately. The breakable seal is designed to break easily under minimal pressure, allowing immediate mixing upon activation and significantly reducing reconstitution time.
Solution Approach 2:
The patent merges the reconstituting solution with the lyophilized product in a single integrated chamber system. Once the breakable seal is breached, the solution automatically mixes with the pharmaceutical product without requiring separate manipulation steps, thereby accelerating the reconstitution process.
3Reliability
If additional manipulation steps are used outside the bag, then reconstitution can be performed, but the risk of accidental exposure to healthcare workers increases
Solution Approach 1:
The flexible bag system is designed to be self-contained and self-activating. The breakable seal automatically breaks when minimal pressure is applied during normal handling, allowing the reconstituting solution to mix with the pharmaceutical product without requiring healthcare workers to open containers or manipulate components outside the sealed bag, thereby protecting them from exposure.
Solution Approach 2:
The breakable seal acts as an intermediary barrier that maintains isolation between the lyophilized product and the external environment until activation. This seal is integrated into the flexible bag structure, providing a simple yet effective protective mechanism that eliminates the need for complex external handling procedures.
4Ease of operation
If a breakable seal is used to separate chambers, then in-bag mixing is enabled, but the seal must withstand specific pressure thresholds
Solution Approach 1:
The breakable seal is designed with non-uniform structural properties: it is stronger in regions requiring pressure resistance during storage and transport, and weaker at specific locations where minimal pressure can cause breaking during activation. This local variation in quality allows the seal to maintain integrity during handling while enabling easy activation when needed.
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
Reduces reconstitution time, minimizes exposure risks for healthcare workers, and enhances compliance by providing a self-contained, ready-to-administer product that maintains product integrity and safety.
Implementation Method 1
Lyophilization or freeze-drying is a technique applied to pharmaceutical products. Through lyophilization, the shelf-life of pharmaceutical products that would have been minimal in a liquid state may be extended and standardized. 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.
Implementation Method 2
primary drying (sublimation)
Implementation Method 3
A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution
Data Source
AI summary
A multiple chamber flexible pharmaceutical bag includes a front film and a back film joined to the front film around a perimeter of the pharmaceutical bag to define a first chamber holding a lyophilized pharmaceutical product and a second chamber holding a reconstituting solution for reconstituting the lyophilized pharmaceutical product held in the first chamber. The pharmaceutical bag includes a seal disposed between the first chamber and the second chamber and defining a connection between the front film of the pharmaceutical bag and the back film of the pharmaceutical bag. The seal breaks when a predetermined amount of force is applied to the pharmaceutical bag such that the connection between the front surface and the back surface of the pharmaceutical bag is torn apart to fluidly connect the second chamber to the first chamber. The front film, the back film, and the seal are comprised of the same material.