Plunger Alignment Device for Sterile Pharmaceutical Container Closure

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Solution Overview

Problem

The process of closing containers filled with pharmaceuticals, particularly lyophilized products in dual chamber syringes, is cumbersome and costly due to the complexity of maintaining sterility and efficiently sealing the containers during preparation.

Innovation Solution

A device comprising a plunger, plunger seat, container carrier, and spacer that aligns the plunger for easy insertion into the container opening, allowing for efficient sealing while maintaining sterility and simplifying the process of lyophilization and reconstitution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If plungers are automatically pushed or sucked into container openings in a sterile environment, then container sealing reliability is improved, but device complexity and operational effort increase

Engineering Contradiction:
Improvecontainer sealing reliabilityVSAvoidclosing process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The plunger is pre-positioned in the plunger seat in a ready-to-insert state, aligned with the container opening. The spacer pre-defines the position and alignment of the plunger seat relative to the container carrier, so that when the container is placed on the carrier, the plunger is already positioned for immediate insertion without requiring complex sterile handling operations.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device structure itself provides the alignment and positioning functions through the spacer and container carrier arrangement. The plunger seat automatically aligns the plunger with the container opening when the container is placed on the carrier, eliminating the need for additional alignment mechanisms or complex sterile manipulation procedures.

Inventive Principle:
Principle #25Self-service

2Device complexity

If plungers are manually inserted into container openings, then device complexity is reduced, but manufacturing precision and alignment accuracy deteriorate

Engineering Contradiction:
Improveclosing device complexityVSAvoidplunger alignment precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The plunger seat acts as an intermediary component that holds the plunger in a predefined alignment. The spacer serves as another intermediary that pre-defines the position and alignment of the plunger seat relative to the container carrier. These intermediary components ensure precise alignment without requiring complex manual manipulation or additional alignment mechanisms.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Stability of the object's composition

If dual chamber syringes are closed during lyophilization preparation, then pharmaceutical product stability is improved, but processing time and operational effort increase

Engineering Contradiction:
Improvepharmaceutical product stabilityVSAvoidpreparation process time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The plunger is pre-positioned in the plunger seat with alignment already defined by the spacer. When the container is placed on the carrier, the plunger is ready for immediate insertion without requiring additional alignment or positioning steps, reducing the time required for the closing operation while maintaining product stability.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS11697514B2Closing a chamber of a container for a pharmaceutical product
Publication Date: 2023.07.11 F HOFFMANN LA ROCHE INC
  • US11697514B2 patent drawing
  • US11697514B2 patent drawing
  • US11697514B2 patent drawing

AI summary

A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.