Aseptic Assembly of Large-Volume Injection Device Fluid Paths

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Solution Overview

Problem

Assembling large volume injection devices in a sterile or aseptic manner to establish a fluid connection with medicament containers is complicated and expensive, posing challenges in maintaining sterility and preventing microorganism introduction.

Innovation Solution

A method involving the selection and sterilization of medicament delivery device components, followed by assembly under sterile conditions, including the placement of a medicament container in a sled and securing it with a housing drive cap, to create an aseptic fluid path connection without requiring a clean room environment for all assembly steps.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If assembly is performed in a clean room environment to maintain sterility, then sterility is improved, but manufacturing cost and complexity increase

Engineering Contradiction:

ImprovesterilityVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into sterile components (medicament container, fluid path) and non-sterile components (housing, drive mechanism). Only the sterile components require clean room assembly, while non-sterile components can be assembled outside the clean room, reducing manufacturing complexity while maintaining sterility where needed.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sterile components are pre-assembled and sterilized separately before final assembly. The medicament container is pre-filled and sealed in a sterile environment, then integrated with the non-sterile housing components outside the clean room, eliminating the need for complete clean room assembly.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If complete sterilization of all components is performed, then sterility is improved, but manufacturing cost increases

Engineering Contradiction:

ImprovesterilityVSAvoidmanufacturing cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

Different sterilization levels are applied to different components based on their functional requirements. The fluid path and medicament container receive complete sterilization, while external housing components use less costly cleaning methods, reducing overall manufacturing cost while maintaining sterility in critical areas.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The device is designed as a single-use disposable unit. The entire assembly or critical sterile components are pre-sterilized and sealed in sterile packaging, eliminating the need for expensive re-sterilization processes and allowing cost-effective manufacturing through standardized sterilization protocols.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Ease of operation

If a fluid connection is established between the needle and medicament container, then functionality is improved, but risk of microorganism introduction increases

Engineering Contradiction:

Improvefluid connectionVSAvoidmicroorganism introduction

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

A sterile barrier or seal acts as an intermediary between the sterile medicament container and the external environment. The fluid path maintains a sealed connection that allows medicament flow while preventing microorganism contamination during the establishment of fluid connection.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The sterile components are pre-protected with sterile barriers and seals before assembly. The sealing mechanism is designed to maintain sterility during the fluid connection establishment, preventing microorganism introduction at the critical interface between the needle and medicament container.

Inventive Principle:

Principle #9Preliminary anti-action

Data Source

PatentUS20260069763A1Method of assembling a large volume delivery device

Publication Date: 2026.03.12 SANOFI AVENTIS DEUT GMBH

AI summary

A method of assembling a medicament delivery device is provided. The method can include selecting a medicament delivery device main body, comprising: an external housing including a substantially rigid body with a top cover and a bottom cover; a moveable medicament container sled; a needle insertion mechanism; and a fluid path operable to connect a needle of the needle insertion mechanism with a medicament container. The method can further include selecting a medicament container including a container body and plunger and selecting a drive mechanism and housing drive cap. The method can also include sterilizing the medicament delivery device main body, the drive mechanism, and the housing drive cap; sterilizing the medicament container; and under sterile aseptic conditions, assembling the medicament delivery device by placing the medicament container in the medicament container sled.