Pre-Filled Vial Stopper Simulation for High-Altitude Integrity

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

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

VSEngineering 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

Engineering Contradiction:
Improveaccuracy of altitude limitation quantificationVSAvoidtime required for experimentation
Core Design Contradiction:
Measurement precisionVSLoss of time

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.

Inventive Principle:
Principle #26Copying

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.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Engineering Contradiction:
Improvereliability of experimental dataVSAvoidaccuracy of altitude limitation quantification
Core Design Contradiction:
ReliabilityVSMeasurement precision

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.

Inventive Principle:
Principle #26Copying

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.

Inventive Principle:
Principle #25Self-service

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

Engineering Contradiction:
Improvespeed of risk assessmentVSAvoidcomplexity of simulation model
Core Design Contradiction:
ProductivityVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Methodology Applied
Scientific EffectGas expansion due to pressure decrease: Boyle's Law

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

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentUS20250342296A1Method and system of simulating operational integrity of a pre-filled vial
Publication Date: 2025.11.06 PFIZER INC
  • US20250342296A1 patent drawing
  • US20250342296A1 patent drawing
  • US20250342296A1 patent drawing

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.