Method for protecting and unprotecting the fluid path in a controlled environment enclosure

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Solution Overview

Problem

Controlled environment enclosures require human intervention via gloves, which poses a risk of puncture, and fluid paths made from flexible tubing allow gas permeability, leading to contamination issues during decontamination and operation, especially for sensitive products.

Innovation Solution

A method using a robotic arm manipulation system to install, protect, and unprotect fluid paths within controlled environment enclosures, allowing for automated decontamination and operation without gloves, utilizing pre-sterilized tubing and tamper-evident devices to ensure aseptic handling and reduce permeability through additional layers or coatings.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If gloves are used for manual manipulation inside controlled environment enclosures, then human intervention is enabled, but the risk of glove puncture increases leading to contamination

Engineering Contradiction:
Improvemanual manipulation capabilityVSAvoidglove integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention extracts the harmful element (gloves) from the system by implementing a robotic manipulation system that operates inside the controlled environment enclosure without requiring glove protection, thereby eliminating the puncture risk while maintaining manipulation capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces a robotic arm as an intermediary between the operator and the controlled environment, allowing indirect manipulation without direct human contact through glove barriers that are prone to failure

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If flexible tubing is used for fluid paths in controlled environment enclosures, then fluid transfer flexibility is improved, but gas permeability increases allowing contamination during decontamination

Engineering Contradiction:
Improvefluid path flexibilityVSAvoidgas permeability
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The invention applies composite material construction to the fluid path tubing, combining multiple material layers with different properties where the outer layers provide gas barrier functionality while inner layers maintain fluid compatibility and flexibility, thereby reducing gas permeability while preserving adaptability

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The invention uses multi-layer flexible tubing construction where thin film barriers with low gas permeability are integrated into the tubing structure, providing protection against gas diffusion during decontamination while maintaining the flexibility needed for fluid transfer operations

Inventive Principle:
Principle #30Flexible shells and thin films

3Productivity

If automated equipment is installed in controlled environment enclosures, then productivity is improved, but device complexity increases requiring human intervention

Engineering Contradiction:
Improveautomation capabilityVSAvoidequipment complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention designs the robotic manipulation system with multi-functionality to perform various operations (fluid path installation, decontamination, equipment manipulation) within the controlled environment, reducing the need for specialized complex equipment while maintaining productivity

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Eliminates the risk of glove punctures and minimizes contamination by enabling automated fluid path management within controlled environments, ensuring aseptic conditions and reducing gas permeability, thus enhancing the safety and efficiency of operations.

Implementation Method 1

A method using a robotic arm manipulation system to install, protect, and unprotect fluid paths within controlled environment enclosures

Methodology Applied
Scientific EffectMechanical manipulation:

Implementation Method 2

decontaminating the controlled environment enclosure... Suitable chemical agents known in the art include hydrogen peroxide, ozone, beta-propiolactone, aziridine, formaldehyde, chlorine dioxide, ethylene oxide, propylene oxide, and peracetic acid

Methodology Applied
Scientific EffectChemical decontamination:

Implementation Method 3

This may be done thermally using steam or chemically using chemical agents

Methodology Applied
Scientific EffectThermal decontamination:

Implementation Method 4

Fluid paths within the controlled environment enclosures may be made from flexible tubing materials and can therefore have significant gas permeability. Gases that naturally occur in air, such as oxygen and carbon dioxide, as well as chemical decontamination agents, are known to diffuse into these tubing materials

Methodology Applied
Scientific EffectGas permeability reduction:

Data Source

PatentEP2734300B1Method for protecting and unprotecting the fluid path in a controlled environment enclosure
Publication Date: 2021.04.21 VANRX PHARMASYST
  • EP2734300B1 patent drawingFigure 1
  • EP2734300B1 patent drawingFigure 2
  • EP2734300B1 patent drawingFigure 3

AI summary

A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure. The apparatus similarly allows the fluid path to be unprotected for use without the use of gloves, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated.