Sterile Sampling Device with Flexible Membrane

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Solution Overview

Problem

Existing sampling devices in industries like brewing and pharmaceuticals face challenges in ensuring sterile sampling without glass containers, which can be contaminated by airborne pathogens and require costly maintenance, and existing solutions do not adequately prevent contamination or ensure sterility during sampling.

Innovation Solution

A sampling device with a flexible-walled container and a three-way valve that prevents airborne contamination, featuring a tamper-evident blocking device and steam sterilization capabilities, ensuring sterility until sample collection and allowing for the sampling of viscous liquids without vent openings.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a glass bottle is used for sampling, then the sample container is rigid and can be sterilized, but the risk of airborne contamination increases and maintenance costs rise

Engineering Contradiction:
Improvesterility assuranceVSAvoidairborne contamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a flexible membrane closure instead of a rigid glass bottle opening, creating a barrier that prevents airborne contamination while allowing sampling. The membrane acts as a flexible seal that maintains sterility until sampling occurs, eliminating the contamination risk associated with open glass bottle systems.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If a glass bottle system is used, then sampling can be performed, but prior maintenance, separation, cleaning, assembly and autoclaving are required

Engineering Contradiction:
Improvesterility assuranceVSAvoidpreparation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The sampling device is pre-sterilized and packaged in a sterile state before use. The membrane closure and sampling apparatus are prepared in advance under controlled conditions, eliminating the need for on-site cleaning, assembly, and autoclaving operations that consume time and require user skill.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs a disposable sampling device that is pre-sterilized and discarded after single use. This eliminates the need for repeated maintenance, cleaning, and autoclaving of expensive glass bottle systems, reducing both time investment and maintenance costs while ensuring consistent sterility.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If a vent opening with filter is used in glass bottle, then airborne micro-organisms are prevented from ingress, but the system becomes complex and requires maintenance

Engineering Contradiction:
Improveprotection against airborne micro-organismsVSAvoidsampling device structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the complex vent opening with filter system with a simple flexible membrane closure. The membrane itself acts as the barrier against airborne micro-organisms, eliminating the need for separate vent openings, filters, and associated maintenance while maintaining protection against contamination.

Inventive Principle:
Principle #30Flexible shells and thin films

4Ease of operation

If a flexible-walled container is used, then the container can expand during filling without vent opening, but sterilization methods must be adapted

Engineering Contradiction:
Improvefilling processVSAvoidsterilization capability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The flexible-walled container with membrane closure is pre-sterilized in the manufacturing process before use. This preliminary sterilization ensures reliability without requiring complex sterilization methods during operation, adapting the sterilization approach to the flexible container design.

Inventive Principle:
Principle #10Preliminary action

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 solution provides a sterile, cost-effective sampling method that prevents contamination and ensures representative samples, reducing user-dependent risks and maintenance costs while allowing for efficient sterilization and handling of viscous liquids.

Implementation Method 1

The three-way valve allows sterilization of the connection between a sampling valve and the sampling device up to the three-way valve

Methodology Applied
Scientific EffectPhysical barrier (valve closure):

Implementation Method 2

cleaning fluid, such as steam, is passed through the sampling valve, the tube and the pre-chamber in the plug so that the path of the sample is cleaned and/or sterilized

Methodology Applied
Scientific EffectSteam sterilization:

Implementation Method 3

a vent opening arranged between the interior and the surroundings of the bottle and provided with a filter to prevent the ingress of airborne micro-organisms

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 4

the use of a sample container with a flexible wall obviates the need for a vent opening as the sample container can expand as it is being filled with a sample

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Data Source

PatentEP3244188B1Use of a sampling device
Publication Date: 2019.12.04 KEOFITT
  • EP3244188B1 patent drawingFigure 1~1a
  • EP3244188B1 patent drawingFigure 2
  • EP3244188B1 patent drawingFigure 3~4

AI summary

The sampling device comprises a sample container (15) with a flexible wall (17) and with an interior, a coupling member (27), such as a socket, for coupling to a sample outlet connector (5) and a communicating passage (23) between the coupling member (27) and the interior of the sample container (15), at least the interior of the sample container (15) being sterile. The sampling device additionally comprises a sterility protection (37) for ensuring the sterility of the interior of the sample container (15).