Sterile Hatch Inflatable Gasket Maintenance

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Solution Overview

Problem

Existing communication hatches between isolators used for handling radiopharmaceuticals are difficult and laborious to maintain due to inaccessible gaskets, requiring disconnection of isolators and compromising sterility during replacement.

Innovation Solution

A hatch system with a dynamic inflatable gasket and a roto-translatory movement mechanism allows for easy access and replacement of gaskets from within the chamber, maintaining sterility and simplifying the assembly and disassembly process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional fixed gaskets are used in the communication passage between isolators, then the seal is reliable, but the gasket replacement is laborious and requires disconnection of isolators

Engineering Contradiction:
Improveseal reliabilityVSAvoidgasket replacement ease
Core Design Contradiction:
ReliabilityVSEase of repair

Solution Approach 1:

The gasket is designed to be expandable rather than fixed, allowing it to transition from a compressed state during installation/maintenance to an expanded state during operation. This dynamic transformation enables the gasket to be easily replaced by deflating and removing it, while still providing reliable sealing when inflated and compressed between the frame and door.

Inventive Principle:
Principle #15Dynamics

2Ease of repair

If the isolators are disconnected to replace gaskets, then the gaskets can be accessed and replaced, but sterility is compromised

Engineering Contradiction:
Improvegasket accessibilityVSAvoidsterility maintenance
Core Design Contradiction:
Ease of repairVSObject-affected harmful factors

Solution Approach 1:

The hatch assembly is segmented into separable components: the door, the expandable gasket, and the frame. The gasket can be independently removed by deflating it, allowing maintenance personnel to access and replace the gasket without disconnecting the isolators. The door remains in place, maintaining the sterile barrier while enabling gasket replacement.

Inventive Principle:
Principle #1Segmentation

3Device complexity

If a single door hatch system is used, then the structure is simple, but the gasket replacement requires isolator disconnection

Engineering Contradiction:
Improvehatch structure simplicityVSAvoidgasket replacement ease
Core Design Contradiction:
Device complexityVSEase of repair

Solution Approach 1:

The gasket's physical state is changed from a permanently compressed elastic element to an inflatable/deflatable element. By controlling the inflation parameter (air pressure), the gasket can be easily expanded for sealing or deflated for removal, transforming a complex maintenance operation into a simple parameter adjustment that doesn't require isolator disconnection.

Inventive Principle:
Principle #35Parameter changes

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 hatch system ensures a sealed communication passage while allowing for easy replacement of gaskets without disconnecting the isolators, maintaining sterility and reducing maintenance complexity.

Implementation Method 1

an annular gasket (4), preferably of the dynamic expansion type, and in particular of inflatable type, to create a seal

Methodology Applied
Scientific EffectInflation:

Data Source

PatentEP3125252B1Hatch to establish a communication between two chambers for processing under sterile conditions
Publication Date: 2018.12.05 COMECER
  • EP3125252B1 patent drawingFigure 1~2
  • EP3125252B1 patent drawingFigure 3a~3b
  • EP3125252B1 patent drawingFigure 4

AI summary

A hatch to establish a communication between two chambers for processing under sterile conditions, a first wall (23) of the first chamber (19) having a first opening (21) and a second wall (24) of the second chamber (20) having a second opening (22), which is arranged in front of the first opening (21) and has, compared to the latter, a larger cross section. The hatch (1) has a first frame (26), which is positionable between the two openings (21, 22) and has an outer profile that can be inserted into the second opening (22), a second frame (2), which is mounted on the first frame (26) so as to be positioned on the second opening (22), a first annular gasket (27) interposed between the two frames (2, 26), a door (3) movably mounted on the second frame (2), a second annular gasket (28) which can be interposed between the first frame (26) and the first wall (23), and a third annular gasket (29) which can be interposed between the second frame (2) and the second wall (24).