Sterile Packaging With Electron Beam Opaque Screen

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Solution Overview

Problem

Current packaging for sterilized products is inadequate as it can be contaminated during decontamination, causes material alteration, and is incompatible with high-temperature sterilization, leading to deformation and ozone generation, and existing sterilization methods are inefficient and pose risks to materials and atmosphere.

Innovation Solution

A packaging design featuring a plastic tub sealed with a transparent cover sheet, incorporating a selectively impervious material and a screen opaque to electron irradiation, allowing sterilizing gases to pass through while preventing electron beam damage, and equipped with usage indicators for sterilization type identification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a selectively impervious material is used to seal the packaging, then contamination by micro-organisms and bacteria is prevented, but the material alters under electron beam irradiation and generates ozone

Engineering Contradiction:
Improvesterility maintenanceVSAvoidmaterial alteration and ozone generation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The packaging is divided into distinct functional layers: a first selectively impervious layer for sterility maintenance, a second selectively impervious layer for electron beam protection, and a permeable barrier layer for sterilization gas transmission. This segmentation allows each layer to specialize in one function, preventing contamination while avoiding material alteration and ozone generation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A permeable barrier layer is introduced as an intermediary between the selectively impervious material and the sterilization gas. This intermediary layer allows sterilization gas to pass through while preventing direct contact between the electron beam and the selectively impervious material, thereby avoiding material alteration and ozone generation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If high-temperature sterilization is used, then sterilization effectiveness is improved, but the packaging material deforms

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidpackaging deformation
Core Design Contradiction:
ReliabilityVSShape

Solution Approach 1:

The packaging materials are selected and designed with specific physical and chemical parameters that allow them to withstand high-temperature sterilization without deformation. The materials are chosen to have high thermal stability and are designed with appropriate thermal expansion coefficients to maintain structural integrity during autoclaving.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If electron beam decontamination is used, then decontamination effectiveness is improved, but the packaging material is altered and ozone is generated

Engineering Contradiction:
Improvedecontamination effectivenessVSAvoidmaterial alteration and ozone generation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electron beam protection function is extracted and assigned to a separate second selectively impervious layer, while the first selectively impervious layer maintains its sterility function. This extraction allows the electron beam to be blocked before reaching the sterilization gas and adhesive zones, preventing material alteration and ozone generation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The second selectively impervious layer acts as an intermediary barrier between the electron beam and the sterilization gas. It absorbs and blocks the electron beam energy, preventing direct interaction with the adhesive and sterilization gas that would cause material alteration and ozone generation.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If the packaging is made opaque to electron irradiation, then protection against electron beam damage is improved, but sterilization gas penetration is hindered

Engineering Contradiction:
Improveelectron beam protectionVSAvoidsterilization gas penetration
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

Different regions of the packaging have different properties: the second selectively impervious layer is opaque to electron irradiation to protect against electron beam damage, while the permeable barrier layer is transparent to sterilization gas to allow effective penetration. Each layer is optimized for its specific function.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The packaging uses a composite structure combining different selectively impervious materials with different radiation and gas transmission properties. The first selectively impervious material provides sterility protection, the second provides electron beam protection, and the permeable barrier layer provides gas transmission, creating a multi-functional composite packaging system.

Inventive Principle:
Principle #40Composite materials

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

Enables efficient and safe sterilization of products using various methods, including electron beam decontamination, reduces sterilization time, and prevents material alteration and ozone generation, while maintaining product integrity and safety.

Implementation Method 1

a screen which is opaque to at least an electron irradiation passing through the cover sheet or the selectively impervious material

Methodology Applied
Scientific EffectElectron beam absorption: Absorption (EM radiation)

Implementation Method 2

a sheet of a selectively impervious material, secured to the said cover sheet and closing off the window

Methodology Applied
Scientific EffectSelective permeability: Semipermeable Membrane

Implementation Method 3

The latter is, for example, a sheet based on filaments of HDPE (high density polyethylene) or some other polymer, bound together especially by heat and pressure

Methodology Applied
Scientific EffectThermal stability: Heat Treatment

Data Source

PatentUS8056719B2Multipurpose packages for sterile products or products to be sterilized
Publication Date: 2011.11.15 BECTON DICKINSON & CO
  • US8056719B2 patent drawing
  • US8056719B2 patent drawing
  • US8056719B2 patent drawing

AI summary

The invention concerns a package (2) for sterilized products or products to be sterilized comprising a plastic box (4) and a lid (16) fixed on the box (4) to seal the latter with a tight sealing zone. The invention is characterized in that the lid (16) comprises: a plastic cover sheet (20) transparent for electronic irradiation and for light radiation; at least a window (22) provided in the cover sheet (20); at least a sheet of selectively sealing material (24) integral with said cover sheet (20) and closing the window (22); and an opaque screen (26, 126) for at least an electronic irradiation passing through the cover sheet or the selectively sealing material, said screen extending inside the package (2), proximate to the cover sheet (20), so as to allow through a sterilizing gas, for example ethylene oxide (ETO) or water vapor, through the selectively sealing material (24).