Pre-Filled Vial Stopper Simulation for High-Altitude Integrity
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Solution Overview
Problem
Current experimental techniques for quantifying altitude limitations during high altitude transportation of pre-filled vials are expensive, time-consuming, and prone to inaccuracies, compromising vial integrity and sterility due to pressure differentials affecting stopper displacement.
Innovation Solution
A digital simulation model using a proportional-integral-derivative (PID) controller block to simulate stopper displacement in pre-filled vials, incorporating friction compensation methods, enabling accurate and rapid assessment of high-altitude shipment risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If physical experimental techniques are used to quantify altitude limitations, then measurement accuracy can be achieved, but the process becomes expensive, time-consuming, and manpower-consuming
Solution Approach 1:
The patent creates a digital copy of the physical vial system through computational modeling. The simulation model replicates the physical behavior of pre-filled vials under altitude-induced pressure differentials, allowing virtual experimentation that eliminates the need for repeated physical tests while maintaining measurement accuracy.
Solution Approach 2:
The patent replaces the mechanical/physical experimental system with a computational simulation system. Instead of physically subjecting vials to altitude conditions in laboratories, the system uses computer-based models to simulate pressure differentials and predict stopper displacement, significantly reducing time and resource requirements.
2Reliability
If physical experimental techniques are used to quantify altitude limitations, then reliable data can be obtained, but reliability is compromised by equipment variation and human error
Solution Approach 1:
The digital simulation creates a virtual replica of the physical system that eliminates variability introduced by laboratory equipment and human operators. The computational model provides consistent, repeatable results by removing the elements of human error and equipment tolerance variations inherent in physical experiments.
Solution Approach 2:
The simulation system is self-executing and self-validating, requiring no human intervention during the simulation process. The computational model automatically calculates stopper displacement under various altitude conditions, eliminating human error and ensuring consistent, reliable results across multiple simulations.
3Productivity
If digital simulation is used to assess high-altitude shipment risks, then cost and time are reduced, but complexity of the simulation model increases
Solution Approach 1:
The patent divides the complex problem of vial integrity assessment into manageable computational components: pressure differential calculation, stopper force analysis, friction modeling, and displacement prediction. This segmentation allows the complex simulation to be constructed from modular, well-defined sub-models that can be developed and validated independently.
Solution Approach 2:
The patent introduces computational models and algorithms as intermediaries between the input parameters (altitude, pressure, vial characteristics) and the output results (stopper displacement, integrity assessment). These intermediary computational layers translate physical principles into predictable outcomes, managing complexity through structured mathematical relationships.
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
Provides accurate and cost-effective simulation of high-altitude limits to maintain vial integrity, ensuring reliable and efficient global distribution of pre-filled syringes and similar containers.
Implementation Method 1
a gaseous portion contained therewithin, pressure differentials can induce undesirable displacement of a stopper
Implementation Method 2
simulating, in a processor of a computing system, a frictional disengaging of a stopper that is engaged with the pre-filled vial
Data Source
AI summary
Method and system of digitally simulating operational integrity of a pre-filled vial. The method includes simulating, in a processor of a computing system, a frictional disengaging of a stopper from the pre-filled vial responsive to a progressively decreasing ambient pressure, the pre-filled vial containing a gaseous portion that is separated from ambient air by the stopper, and generating, by the processor in accordance with the progressively decreasing ambient pressure, a measure corresponding to an aircraft altitude at which the frictional disengaging is initiated.


