Lyophilization Promoting Element for Uniform Heat Transfer
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Solution Overview
Problem
The lyophilization process faces challenges such as inefficient and nonuniform heat transfer, vial-to-vial variability, risk of contamination during handling, and difficulty in tracking vials, leading to issues like product collapse, residual solvent variability, and reduced product yield.
Innovation Solution
A lyophilization promoting element with a base plate featuring regularly arranged apertures made of thermally conductive material, allowing for improved heat transfer between the lyophilizer and vials, and a system with pockets for enhanced thermal conduction, facilitating direct contact with the shelf for uniform heating and vial tracking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If vials are placed directly on shelves without trays or holders, then handling is simpler, but heat transfer becomes nonuniform and vial-to-vial variability increases
Solution Approach 1:
The patent introduces a holder as an intermediary component between the shelf and vials. This holder provides a standardized interface that ensures uniform thermal contact for all vials while maintaining ease of handling through modular tray designs that can be loaded and removed as units.
2Productivity
If vials are tightly packed on trays to maximize space utilization, then productivity increases, but heat transfer efficiency decreases due to inadequate thermal contact
Solution Approach 1:
The holder design incorporates localized thermal contact features at specific points where vials interface with the holder structure. This ensures that heat transfer occurs efficiently at these designated contact points while allowing the overall tray to maintain high density packaging configurations.
3Loss of energy
If trays are removed from under vials after loading to enable direct shelf contact, then heat transfer improves, but risk of contamination during handling increases
Solution Approach 1:
The holder enables continuous thermal contact between vials and the heating surface throughout the entire lyophilization process. The holder remains in place on the shelf for the duration of processing, eliminating the need for tray removal and associated contamination risks while maintaining efficient heat transfer.
4Device complexity
If conventional holders are used without tracking features, then device complexity is reduced, but ability to track individual vials is lost
Solution Approach 1:
The holder incorporates visual tracking features such as colored indicators, numbered positions, or patterned markings that allow operators to easily identify and track individual vial locations. These features add minimal complexity to the holder structure while providing robust tracking capability throughout the manufacturing process.
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 enhances heat transfer efficiency, reduces vial-to-vial variability, minimizes contamination risks, and improves vial tracking, resulting in consistent product quality and increased yield.
Implementation Method 1
a base plate comprising a plurality of apertures, the base plate comprising a thermally conductive material... facilitates the transfer of heat between a lyophilizer and the pre-lyophilization solution
Implementation Method 2
Lyophilization involves the removal of water or other solvents from a given product by a process called sublimation. This occurs when the ice of a frozen product converts directly to the gaseous state without passing through the liquid phase.
Implementation Method 3
Commercial lyophilizers for the pharmaceutical industry are designed to control temperature of a product by using circulating fluid inside the shelves on which the containers are placed. Heat is transferred from the circulating fluid to the shelf, to the container, and then to the product solution
Data Source
AI summary
A lyophilization promoting element to facilitate the transfer of heat between a lyophilizer and a pre-lyophilization solution. The element includes a base plate with a plurality of apertures. The base plate is made of a thermally conductive material and the apertures are regularly arranged within the base plate, each aperture being sized to receive a pharmaceutical vial container containing a pre-lyophilization solution. A method of lyophilizing includes inserting one or more pharmaceutical vial containers into the plurality of apertures of the lyophilization promoting element and placing the lyophilization promoting element holding the one or more pharmaceutical vial containers on a shelf of a lyophilizer.