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 steps and can lead to exposure risks for healthcare workers, errors in reconstitution, and non-compliance with regulations.
Innovation Solution
A multi-chamber flexible bag that allows lyophilization, storage, and reconstitution of pharmaceutical products within the same bag, featuring a breakable seal between chambers to facilitate mixing of the lyophilized product with a reconstituting solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If multiple separate containers and manipulation steps are used for lyophilization, storage, and reconstitution, then each step can be performed with standard equipment, but the process becomes complex, time-consuming, and prone to errors
Solution Approach 1:
The patent combines lyophilization, storage, and reconstitution functions into a single integrated flexible bag system. The bag contains multiple chambers separated by breakable seals, allowing the pharmaceutical product to undergo lyophilization in one chamber and then be reconstituted in the same bag by breaking the seal and adding reconstituting solution from another chamber. This eliminates the need for multiple separate containers and manipulation steps outside the bag.
Solution Approach 2:
The flexible bag serves multiple functions: it acts as the lyophilization container, storage vessel, and reconstitution chamber all in one. The breakable seal mechanism enables the bag to transition between these different functional states, making it a universal device that performs what would traditionally require multiple specialized equipment and steps.
2Reliability
If the pharmaceutical product is handled outside the bag during reconstitution, then standard reconstitution procedures can be followed, but exposure risks for healthcare workers increase
Solution Approach 1:
The bag performs the reconstitution operation itself through its breakable seal design. When the seal is broken, the reconstituting solution automatically flows into the chamber containing the lyophilized product, and the bag's flexibility allows for self-mixing. This eliminates the need for healthcare workers to manually handle the product outside the bag, reducing exposure risks while maintaining ease of operation.
3Loss of time
If reconstitution is performed in a single chamber, then the process is simple, but reconstitution time and potential for error increase
Solution Approach 1:
The bag is divided into multiple chambers separated by breakable seals. One chamber contains the lyophilized pharmaceutical product while another chamber contains the reconstituting solution. This segmentation allows for parallel preparation of both components and enables rapid reconstitution by simply breaking the seal between chambers, reducing reconstitution time despite the added structural complexity.
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 reduces reconstitution time and errors, minimizes exposure risks for healthcare workers, and enhances compliance with regulations by providing a self-contained, ready-to-administer product.
Implementation Method 1
A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution
Implementation Method 2
allow passage of water vapor from the pharmaceutical product during lyophilization of the pharmaceutical product
Implementation Method 3
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 4
The main steps of lyophilizing are freezing (from a liquid state to a solid state), primary drying (sublimation), and secondary drying
Implementation Method 5
Lyophilization or freeze-drying is a technique applied to pharmaceutical products
Data Source
AI summary
A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.