Multi-Material Cryogenic Closure for Seal Integrity and Puncturability

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Solution Overview

Problem

Current elastomeric closures for cryogenic containers lose their seal integrity and become brittle at temperatures below -50°C to -65°C, allowing contamination and evaporation of cryophilic materials due to glass transition, and existing materials with lower glass transition temperatures are either expensive or have undesirable properties.

Innovation Solution

A multi-material elastomeric closure comprising a cryophilic elastomer with a glass transition temperature below -80°C and a non-cryophilic elastomer with a higher glass transition temperature, physically or chemically bonded together, such as in a laminate form, to maintain seal integrity and permeation resistance at cryogenic temperatures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single elastomeric material is used for closure at cryogenic temperatures, then the closure becomes hard and brittle below glass transition temperature, but using materials with lower glass transition temperature may increase cost or introduce contamination

Engineering Contradiction:
Improveseal integrityVSAvoidcontamination
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The closure is divided into two distinct elastomeric layers: a first elastomeric layer with glass transition temperature above -80°C providing puncturability and permeation resistance, and a second elastomeric layer with glass transition temperature below -80°C providing seal integrity at cryogenic temperatures. This segmentation allows each layer to perform its specific function without compromise.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention uses a composite structure combining two different elastomeric materials with complementary properties. The first elastomer (e.g., butyl rubber) provides chemical stability and puncturability, while the second elastomer (e.g., polybutadiene or silicone) maintains elasticity and sealing at cryogenic temperatures, creating a material system that exhibits properties superior to either component alone.

Inventive Principle:
Principle #40Composite materials

2Reliability

If elastomeric closure is used at cryogenic temperatures, then seal integrity is compromised below glass transition temperature, but alternative materials may be expensive or have undesirable properties

Engineering Contradiction:
Improveseal integrityVSAvoidcost and material availability
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The closure structure separates the functional requirements into two layers, allowing the use of conventional, well-established elastomeric materials (butyl rubber, polyisoprene) for the first layer and specialized cryogenic elastomers (polybutadiene, silicone) for the second layer, optimizing both performance and manufacturability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different regions of the closure have different material properties optimized for their specific functions: the first elastomeric layer (outer region) provides puncturability and permeation resistance, while the second elastomeric layer (inner region contacting container) provides cryogenic sealing, allowing each material to be selected for its local performance requirements.

Inventive Principle:
Principle #3Local quality

3Ease of operation

If conventional elastomeric closure is used, then puncturability is good, but seal integrity fails at cryogenic temperatures

Engineering Contradiction:
ImprovepuncturabilityVSAvoidseal integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The dual-layer elastomeric structure assigns puncturability function to the first elastomeric layer (with higher glass transition temperature) while assigning seal integrity at cryogenic temperatures to the second elastomeric layer (with lower glass transition temperature), allowing both properties to coexist in different parts of the same closure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The closure exhibits spatially varying material properties: the outer first elastomer layer maintains puncturability characteristics, while the inner second elastomer layer maintains sealing elasticity at low temperatures, with each layer optimized for its specific operational requirement.

Inventive Principle:
Principle #3Local quality

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 multi-material closure provides a complete seal at cryogenic temperatures, preventing contamination and evaporation, while retaining puncturability and permeation resistance, allowing for immediate removal of containers from lyophilization without warming.

Implementation Method 1

a cryophilic elastomer having a glass transition temperature at cryogenic temperatures

Methodology Applied
Scientific EffectGlass transition temperature:

Implementation Method 2

high resistance to permeation or migration of the material inside the container to the outside

Methodology Applied
Scientific EffectPermeation resistance: Permeation

Data Source

PatentEP2010847B1Cryogenic, elastomeric closure for cryogen containers
Publication Date: 2011.07.06 WEST PHARMACEUTICAL SERVICES INC
  • EP2010847B1 patent drawingFigure 1~4

AI summary

A multi-material, cryogenic, elastomeric closure is provided for sealing a container for samples of cryophilic biological materials, pharmaceuticals or the like. The closure includes at leas one cryophilic elastomer having a glass transition temperature (Tg) below the cryogenic temperature to which the sample is to be subjected and at least one non-cryophilic elastomer having a Tg above the cryogenic temperature. The cryophilic and non-cryophilic elastomers are present in such a manner as to maintain a complete seal of the container opening at the cryogenic temperature.