Robotic Fluid Path Protection in Decontamination Enclosures

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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 materials allow gas and chemical diffusion, leading to contamination issues during decontamination and operation.

Innovation Solution

A method and apparatus using a robotic arm manipulation system to protect and unprotect fluid paths within controlled environment enclosures, allowing for automated decontamination and fluid transfer without human intervention, utilizing pre-sterilized tubes and tamper-evident devices to ensure safety and sterility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If gloves are used for manual manipulation inside the controlled environment enclosure, 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 fluid path from the controlled environment enclosure during decontamination by providing it with a protective covering that extends beyond the enclosure boundaries. This allows the fluid path to be removed from the hazardous environment before decontamination occurs, eliminating the risk of contamination while maintaining the ability to perform manual operations when needed.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The protective covering acts as an intermediary between the fluid path and the decontamination environment. This mediator protects the fluid path from exposure to decontamination agents while still allowing the system to function, thereby resolving the contradiction between needing manual access and preventing contamination.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If flexible tubing materials are used for fluid paths, then ease of installation and manipulation is improved, but gas and chemical diffusion through the tubing increases leading to contamination

Engineering Contradiction:
Improvefluid path installation and manipulationVSAvoidgas and chemical diffusion
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The invention applies preliminary action by providing the protective covering on the fluid path before the fluid path is exposed to the decontamination environment. This pre-protection prevents any potential diffusion or contamination from occurring in the first place, allowing flexible tubing to be used without compromising integrity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The protective covering functions as a flexible shell that envelops the fluid path. This flexible protective layer maintains the ease of manipulation benefits of flexible tubing while adding a barrier against gas and chemical diffusion, thus resolving the contradiction between flexibility and protection.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If the fluid path is protected during decontamination, then contamination risk is reduced, but the complexity of the system increases due to additional protection and unprotection steps

Engineering Contradiction:
Improvefluid path contamination preventionVSAvoidprotection and unprotection mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system is designed to be self-serving by automatically providing and removing the protective covering through integrated mechanical means. The protective covering is initially provided by the system itself, and the same system automatically removes it when no longer needed, eliminating the need for additional manual intervention and reducing overall system complexity.

Inventive Principle:
Principle #25Self-service

4Productivity

If automated equipment is used in the controlled environment, then productivity increases, but the equipment size and complexity require human intervention via gloves

Engineering Contradiction:
Improveautomated operation capabilityVSAvoidequipment size and complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention extracts the fluid path with its protective covering from the controlled environment enclosure before decontamination. This allows automated equipment to operate within the enclosure without requiring gloves for fluid path manipulation, as the fluid path is temporarily removed and protected outside the enclosure during critical operations.

Inventive Principle:
Principle #2Taking out (Extraction)

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 puncture and contamination by enabling automated operation within closed environments, ensuring the integrity of the fluid path and decontamination process, allowing for safe handling of hazardous substances and maintaining sterility.

Implementation Method 1

A remotely operated manipulation system, and in particular a robotic arm manipulation system can be provided within the controlled environment enclosure for protection and/or unprotection of the fluid path

Methodology Applied
Scientific EffectMechanical manipulation: Mechanical Force

Implementation Method 2

Such controlled environment enclosures may be required for aseptic processing of cell cultures and for the manufacture of pharmaceutical products, medical devices, food or food ingredients. In these cases it is a requirement that the controlled environment enclosure be decontaminated. This may be done thermally using steam or chemically using chemical agents.

Methodology Applied
Scientific EffectChemical decontamination: Oxidation

Implementation Method 3

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 barrier: Diffusion Barrier

Data Source

PatentUS9993815B2Method for protecting and unprotecting the fluid path in a controlled environment enclosure
Publication Date: 2018.06.12 VANRX PHARMASYST
  • US9993815B2 patent drawing
  • US9993815B2 patent drawing
  • US9993815B2 patent drawing

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.