Lyophilization Carrier With Metal-Polymer Interface For Vertical Ice Growth
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Solution Overview
Problem
The lyophilization process for pharmaceutical products in cartridges and syringes is inefficient due to their elongated shape, which leads to longer drying times, non-uniform temperature maintenance, and the formation of horizontal ice crystals that impede vapor transmission, as well as challenges in inserting plungers without exposing the product to ambient moisture.
Innovation Solution
A carrier system for tubular containers in a lyophilization chamber, featuring a polymeric upper portion and metallic lower portion to control ice crystal growth and ensure uniform temperature, combined with a plunger insertion mechanism to seal the containers post-processing without exposing them to the environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If cartridges and syringes are placed directly on the lyophilization shelf, then the device complexity is reduced, but the heat transfer efficiency deteriorates due to their elongated shape and narrow profile
Solution Approach 1:
A carrier plate is introduced as an intermediary component between the lyophilization shelf and the cartridges/syringes. The carrier plate serves as a heat transfer medium that contacts both the shelf and the containers, ensuring efficient thermal coupling. This resolves the contradiction by maintaining simple device placement while improving heat transfer through the intermediary plate.
Solution Approach 2:
The invention transitions from direct contact (one-dimensional interface) to indirect contact through the carrier plate (two-dimensional interface). The carrier plate distributes thermal contact across multiple points and surfaces, effectively managing heat transfer for the elongated container geometry without increasing device complexity.
2Volume of moving object
If the container height is increased to accommodate elongated shapes, then the volume capacity is improved, but the drying time increases due to longer vapor travel distance
Solution Approach 1:
The carrier plate acts as a mediator that facilitates vapor transport and heat distribution throughout the extended container length. By providing multiple thermal contact points and vapor escape pathways through the plate structure, it reduces the effective vapor travel distance despite the increased container height, thereby reducing drying time while maintaining volume capacity.
3Object-affected harmful factors
If plungers are inserted before lyophilization, then the product is protected from ambient moisture, but the mass transfer is inhibited during the drying process
Solution Approach 1:
The carrier plate is prepared in advance with appropriate structures (such as openings or channels) that facilitate vapor escape. This preliminary preparation allows plungers to be inserted before lyophilization without blocking vapor pathways, as the carrier plate structure is designed to accommodate both plunger insertion and subsequent vapor transport during drying.
4Use of energy by moving object
If deep sockets are provided in the shelf to receive cartridges, then the heat transfer contact is improved, but the ice crystals grow horizontally instead of vertically, impeding vapor transmission
Solution Approach 1:
The carrier plate provides localized thermal contact at specific positions beneath the cartridges/syringes, concentrating heat transfer where needed without creating extensive horizontal thermal zones. This localized approach promotes vertical ice crystal growth by providing controlled thermal gradients that favor upward crystal development, thereby maintaining vapor transmission efficiency while improving heat transfer contact.
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 enhances heat transfer and vapor removal efficiency, reduces drying time, and maintains product quality by promoting vertical ice crystal growth and allowing controlled plunger insertion, thereby improving the lyophilization process for elongated containers.
Implementation Method 1
The metallic lower portions conduct heat from the tubular containers to the shelf during freezing, and from the shelf to the tubular containers during drying
Implementation Method 2
The polymeric upper portions of the recesses provide thermal shielding for the intermediate portions of the tubular containers during freezing, primary drying and secondary drying
Implementation Method 3
The lyophilization chamber has a shelf for supporting a carrier, and includes means for drawing heat away from a carrier supported on said shelf
Data Source
AI summary
A carrier for supporting containers such as syringes or cartridges in a lyophilization chamber during lyophilization of substances contained therein, comprises a base assembly with an array of holes for receiving the containers. Each hole includes a heat-conductive metal portion for engagement with lower parts of the container held therein and a relatively non-conductive polymeric portion surrounding a portion of the container above the lower portion for enhancing the vertical growth of relatively large ice crystals. An upper part of the carrier supported above the base assembly includes a plunger-holding plate for frictionally holding elastomeric plungers and a pusher plate movable toward the plunger-holding plate and having protrusions for pushing the plungers out of the plunger-holding plate and into the containers before the containers are removed from the chamber.