Prefilled Syringe Plunger Pathway for Stopper Interface Sterilization

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Solution Overview

Problem

Existing prefilled syringes face challenges in achieving complete external surface sterilization, particularly around the plunger and stopper interface, due to difficulties in accessing these areas with sterilizing agents and potential movement of the plunger during varying sterilization conditions, risking contamination of the drug substance.

Innovation Solution

The design of a prefilled syringe with a plunger that forms a pathway for sterilizing agents to reach the stopper interface and incorporates a backstop mechanism to prevent excessive plunger movement, ensuring thorough external surface sterilization and maintaining sterility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the plunger is designed to be movable during sterilization to adapt to pressure changes, then the sterilization completeness is improved, but the risk of plunger movement causing contamination increases

Engineering Contradiction:
Improvesterilization completenessVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary anti-action by designing a backstop mechanism that prevents excessive plunger movement before sterilization issues can occur. The backstop is positioned to limit the plunger's distal movement, ensuring that even under varying sterilization conditions, the plunger cannot move far enough to breach the sterile barrier or cause contamination. This preventive structural constraint resolves the contradiction by allowing necessary movement for sterilization access while preventing harmful excessive movement.

Inventive Principle:
Principle #9Preliminary anti-action

2Productivity

If the sterilizing agent pathway is extended to reach the stopper interface, then the external surface sterilization efficiency is improved, but the device complexity increases

Engineering Contradiction:
Improvesterilization efficiencyVSAvoidplunger structure complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent applies universality by designing the plunger rod to serve multiple functions: it acts as both the actuating mechanism for the stopper and as the pathway conduit for the sterilizing agent. The hollow or lumen structure of the plunger rod allows sterilizing agent flow while maintaining its mechanical function, thereby achieving thorough sterilization without adding separate complex sterilization components. This multi-functional design resolves the contradiction by integrating the sterilization pathway into the existing plunger structure.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Object-affected harmful factors

If the plunger is constrained to prevent movement during sterilization, then contamination risk is reduced, but the ability to achieve complete sterilization of the stopper interface is worsened

Engineering Contradiction:
Improvecontamination riskVSAvoidsterilization completeness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies segmentation by dividing the plunger's movement capabilities into distinct zones: the backstop allows controlled movement within a safe range to enable sterilization agent access, while preventing movement beyond the sterile barrier. This segmented approach to movement control resolves the contradiction by permitting necessary movement for sterilization while constraining excessive movement that would cause contamination.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS12485226B2Prefilled syringe and method of sterilizing a prefilled syringe
Publication Date: 2025.12.02 F HOFFMANN LA ROCHE & CO AG
  • US12485226B2 patent drawing
  • US12485226B2 patent drawing
  • US12485226B2 patent drawing

AI summary

A prefilled syringe is disclosed that includes a barrel, a stopper displaceable within and defining a sealed chamber in an interior of the barrel, a liquid filled in the chamber of the barrel, and a plunger extending within the barrel. The stopper expels the liquid out of the barrel via an orifice when being forwarded towards the orifice by the plunger such that a volume of the chamber is reduced. The plunger includes a proximal portion, a distal portion and a rod portion extending between the proximal portion and the distal portion. The plunger is shaped to form a pathway between an opening of the barrel and a segment where the proximal portion of the plunger is neighboring the stopper such that a sterilizing agent can be provided through the opening of the barrel to the segment where the proximal portion of the plunger is neighboring the stopper.