Packaged Medicine Device Sterilization via Hydrogen Peroxide Atmosphere

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Solution Overview

Problem

Existing medicine administration devices are difficult to assemble in a sterile state, and maintaining sterility during packaging is challenging, especially for devices with multiple components like prefilled syringes and puncture needles.

Innovation Solution

A manufacturing method involving a cylindrical case that encapsulates a medicine administration device, including a prefilled syringe and a puncture needle, where hydrogen peroxide is added to the case interior to create a sterilizing atmosphere within a sealed package, ensuring the device remains sterile until use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple components (prefilled syringe, puncture needle, etc.) are assembled together, then the device functionality is improved, but maintaining sterility during assembly and packaging becomes more difficult

Engineering Contradiction:

Improvedevice functionalityVSAvoidsterility maintenance

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The device is divided into separate components (puncture needle, prefilled syringe, cylindrical case) that are packaged individually in separate sterile packages. Each component maintains its sterility independently until the moment of use, when they are assembled together. This segmentation allows complex functionality to be achieved while maintaining sterility of each component throughout storage and transport.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Each component is pre-sterilized and packaged separately before assembly. The puncture needle is sterilized and sealed in its own package, the prefilled syringe is sterilized and sealed, and only when ready for use are these pre-sterilized components assembled together. This preliminary sterilization action ensures sterility is maintained throughout the supply chain.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If the device is packaged in a sealed package, then sterility is maintained, but the sterilization process becomes more complex

Engineering Contradiction:

Improvesterility maintenanceVSAvoidsterilization process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The sterilization process is extracted from the final assembled device and applied separately to each component before packaging. Each component (needle, syringe, case) undergoes its own sterilization process independently, then is sealed in its own package. This extraction simplifies the overall sterilization process compared to sterilizing the complete assembled device.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses disposable sterile packaging materials (sealed packages, sterile barriers) that are discarded after a single use. Each component is packaged in a new sterile package that ensures sterility without requiring complex reusable sterilization equipment or processes for the packaging itself.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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

The method effectively sterilizes both the interior and exterior of the packaged medicine administration device, maintaining a sterile state until the package is opened, suitable for use in controlled environments like operating rooms or ICUs.

Implementation Method 1

adding hydrogen peroxide to a site to be located on an inner side of the cylindrical case of the cylindrical case-encapsulated medicine administration device

Methodology Applied

Scientific EffectHydrogen peroxide sterilization: Hydrogen Peroxide

Implementation Method 2

sterilizing the cylindrical case-encapsulated medicine administration device with an hydrogen peroxide atmosphere formed by the added hydrogen peroxide

Methodology Applied

Scientific EffectOxidation: Oxidation

Data Source

PatentUS12178987B2Manufacturing method for packaged medicine administering device

Publication Date: 2024.12.31 TERUMO KK

AI summary

A manufacturing method for a packaged medicine administration device that includes a medicine administration device including an outer tube filled with a medicine, and a puncture device for medicine administration; a cylindrical case encapsulating and holding the medicine administration device; and a package accommodating the cylindrical case-encapsulated medicine administration device encapsulated and held by the cylindrical case, the package being sealed, the manufacturing method including: a step of preparing the cylindrical case-encapsulated medicine administration device; a step of adding hydrogen peroxide to a site to be located on an inner side of the cylindrical case; a step of accommodating the cylindrical case-encapsulated medicine administration device in the package; a step of sealing the package; and a step of sterilizing the cylindrical case-encapsulated medicine administration device with a hydrogen peroxide atmosphere formed by the added hydrogen peroxide in a state in which the package is sealed.