Double Compartment Syringe with Movable Partition for Sterile Lyophilization
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Solution Overview
Problem
Existing solutions for lyophilizing pharmaceutical compositions in syringes face challenges in maintaining sterility and efficiently mixing lyophilized solids with reconstitution media, particularly due to limited gas exchange areas and contamination risks during the lyophilization process.
Innovation Solution
A double compartment container with a bypass system allows for separate storage and mixing of lyophilized solids and reconstitution media, where the second plug with primary conduits facilitates the transfer of the liquid reconstitution medium into the compartment containing the lyophilized solid, ensuring sterility and efficient mixing without external intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard syringe with two pistons and a bypass is used for lyophilizing pharmaceutical compositions, then mixing of lyophilized solids with reconstitution media can be achieved, but maintaining sterility during the lyophilization process becomes difficult due to limited gas exchange areas and contamination risks
Solution Approach 1:
The syringe is divided into two separate compartments by a movable partition, with the first compartment for lyophilization and the second compartment for reconstitution media. This segmentation allows independent sterilization and processing of each compartment, maintaining sterility while simplifying the overall process.
Solution Approach 2:
The lyophilization process is completed in advance in the first compartment before the partition is moved to enable mixing. This preliminary action allows the solid pharmaceutical composition to be fully lyophilized and sealed in a sterile environment before introducing the liquid media, eliminating contamination risks during the lyophilization phase.
2Ease of manufacture
If a bypass system is used to enable gas exchange during lyophilization, then lyophilization can proceed, but contamination risks increase due to the open connection between compartments
Solution Approach 1:
The partition between compartments is designed to be movable rather than fixed. It remains in a closed position during lyophilization to prevent contamination, and is dynamically opened only after lyophilization is complete and the first compartment is sealed, allowing gas exchange and mixing without exposing the lyophilized material to contamination risks.
Solution Approach 2:
The movable partition acts as an intermediary that controls the interaction between the two compartments. It maintains separation and sterility during lyophilization, then facilitates controlled mixing afterward, mediating the transition between the two operational phases without introducing contamination.
3Reliability
If the container design allows for separate storage of lyophilized solids and reconstitution media, then sterility is maintained, but the mixing process requires additional steps and time
Solution Approach 1:
The system is designed to perform mixing automatically once the partition is moved. The pressure differential and flow paths are configured so that the reconstitution media automatically flows into the first compartment and mixes with the lyophilized solids without requiring external intervention, shaking, or additional mixing steps, reducing preparation time while maintaining sterility.
Solution Approach 2:
The storage and mixing functions are combined in a single integrated device. The movable partition and bypass system allow the same container to maintain separate storage for sterility and then facilitate rapid mixing when needed, eliminating the need for separate storage containers and manual transfer operations that would consume time.
4Reliability
If a complex plugging system is used to maintain sterility during lyophilization, then sterility can be preserved, but mass production becomes difficult and costs increase
Solution Approach 1:
The movable partition serves multiple functions: it separates compartments during lyophilization, controls gas exchange, enables mixing when moved, and facilitates sterilization processes. This multi-functionality eliminates the need for multiple separate components and complex plugging systems, simplifying the manufacturing process and enabling mass production while maintaining sterility.
Solution Approach 2:
The syringe is designed as a disposable single-use device with an integrated movable partition system. This eliminates the need for complex, expensive, and difficult-to-manufacture reusable plugging systems. The entire assembly can be sterilized as one unit and discarded after use, greatly simplifying mass production and reducing costs while ensuring sterility.
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 approach enables reliable storage and rapid mixing of pharmaceutical compositions, maintaining sterility and preventing premature efficacy loss, while allowing for easy industrial-scale production and use of the mixed solution directly before administration.
Implementation Method 1
the bypass having a length L... urging the first plug toward the second end until at least one first opening is in fluid communication with the bypass, the first compartment, and the second compartment
Implementation Method 2
The turbulence generated by a second plug disposed in the inventive container facilitates rapid dissolution and/or dispersion of a solid component in a liquid reconstitution medium... at least one of the primary conduits can direct liquid flow out of the second opening along a line that is not parallel to the longitudinal axis
Data Source
Figure 1~2
Figure 3
Figure 4A~4C
AI summary
A container and methods for storing and mixing a two-component composition is provided. The container includes a body, a first plug and a second plug. The body has a first end, a second end, and a bypass with a length L disposed between the first and second ends. The first and second plugs are slidably disposed in the body and define a first compartment. A second compartment is disposed in the body between the second plug and the second end. The second plug has a first edge, a second edge, and a plurality of spaced-apart primary conduits extending through the second plug. Each primary conduit has a separate first opening. A distance D extends longitudinally from the first edge to the second edge and a distance E extends longitudinally from the first edge to the first opening that is nearest the first edge. D ≥ L and E < L.