Lyophilization Syringe Thermal Block Uniform Heating
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Solution Overview
Problem
The lyophilization process is inefficient due to non-uniform heating during batch lyophilization, leading to variations in sublimation rates across vials or syringes, resulting in incomplete drying and increased cycle times.
Innovation Solution
A lyophilization assembly featuring a thermal block with heat-conductive material and wells designed to accommodate containers, ensuring uniform heat transfer through deformation, combined with a syringe design for in-situ lyophilization and reconstitution, and a venting mechanism for gas escape during processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If convection and radiation are used for heat transfer during batch lyophilization, then the process can be performed, but non-uniform heating occurs leading to higher sublimation rates at periphery versus center
Solution Approach 1:
The patent introduces a thermal block as an intermediary heat transfer medium between the heat source and the lyophilization containers. The thermal block conducts heat uniformly across all containers, eliminating the non-uniform heating pattern that occurs with direct convection and radiation. This mediator ensures that both peripheral and central containers receive equivalent heat treatment.
Solution Approach 2:
The patent replaces the conventional convective and radiative heat transfer mechanisms with thermal conduction through a thermal block. This substitution of heat transfer mode enables uniform heat distribution across all containers in the batch, solving the problem of peripheral overheating versus central underheating.
2Loss of time
If traditional convection and radiation methods are used, then batch lyophilization can proceed, but cycle times increase due to non-uniform drying
Solution Approach 1:
The thermal block serves as a mediator that distributes heat uniformly to all containers simultaneously, enabling parallel processing with consistent drying rates. This eliminates the sequential drying pattern that extends cycle times while maintaining uniformity.
Solution Approach 2:
The patent changes the heat transfer parameters by switching from convective/radiative modes to conductive mode through the thermal block. This parameter change enables both shortened cycle times and uniform drying across all containers.
3Ease of operation
If lyophilization is performed in vials or ampoules, then the process can be completed, but the lyophilized medication requires additional storage infrastructure
Solution Approach 1:
The patent designs the lyophilization syringe to serve multiple functions: it is both the container for the lyophilized medication and the administration device. This multi-functionality eliminates the need for separate storage infrastructure and vial handling systems, making the syringe universally applicable for both processing and delivery.
4Ease of manufacture
If lyophilization is performed directly in a dispensing syringe, then labor is reduced and product waste is minimized, but uniform heat transfer is challenging
Solution Approach 1:
The thermal block acts as an intermediary that ensures uniform heat transfer to the syringe container during in-situ lyophilization. This mediator enables the syringe to be processed directly without compromising heating uniformity, thus achieving both ease of manufacture and manufacturing precision.
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 significantly reduces lyophilization cycle times, achieves uniformity in batch processing, and allows for efficient storage and administration of pharmaceuticals at room temperature, enhancing stability and shelf life.
Implementation Method 1
utilizing an apparatus and methodology whereby lyophilization cycles can be shortened using novel design techniques and materials... a thermal block made from heat conductive material
Implementation Method 2
involves freezing a product (typically a liquid or water-containing product), lowering pressure, then removing the ice via sublimation
Implementation Method 3
removing the ice via sublimation
Data Source
AI summary
Herein described are an assembly, apparatus, and method for lyophilization that utilizes a thermal block made from a conductive material, the block having multiple wells designed and dimensioned to receive containers carrying material to be lyophilized in situ. In preferred embodiments, a vented silicone pad covers the wells and secures the containers therein, and a similarly vented rigid plate in turn secures the silicone pad by fastening it to the thermal block. The assembly can be turned up to 90 degrees resulting in the turning of the containers from an upright position to a horizontal position, a position in which the distance through which sublimation must progress is drastically reduced so as to greatly enhance the efficiency of the lyophilization process.