Docking System Length Compensation Isolator Transfer

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Solution Overview

Problem

Current docking systems face challenges in safely transferring powdered pharmaceuticals from an isolator to a preparation container while maintaining sterile conditions and adhering to stringent contamination control requirements, particularly for highly active and finely powdered cytostatics, due to issues with scattering, contamination risks, and the weight and handling limitations of preparation containers.

Innovation Solution

A docking system comprising A and B parts with a compensator for length compensation, bayonet locks for secure connection, and a rotary device for controlled product transfer, allowing vertical transfer without manual handling and minimizing contamination risks, while maintaining sterility and compliance with OEL and OEB values.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If complex airlock systems are used to transfer pharmaceuticals from the isolator, then operator safety and sterility are improved, but device complexity and operational effort increase considerably

Engineering Contradiction:
Improvesterility maintenanceVSAvoidairlock system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The docking system is divided into two separate parts: part A attached to the isolator and part B attached to the preparation container. These parts connect directly to each other without requiring complex airlock mechanisms, simplifying the overall system while maintaining sterility through the sealed connection between the two parts.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The docking system acts as an intermediary connection between the isolator and preparation container, providing a controlled transfer interface that maintains sterility without requiring the preparing container to enter the isolator, thus avoiding complex airlock systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If mixing containers are positioned horizontally using integrated trolleys, then operator safety is improved, but the system requires complex handling equipment for vertical movement

Engineering Contradiction:
Improveoperator safetyVSAvoidvertical movement equipment
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The docking system enables vertical positioning of the preparation container at the same level as the isolator opening, eliminating the need for complex vertical lifting equipment. The container remains horizontally accessible while achieving vertical alignment through the docking mechanism itself.

Inventive Principle:
Principle #12Equipotentiality

3Reliability

If the isolator lid is closed during powder transfer, then sterility is improved, but the transfer process becomes more complex requiring additional opening/closing operations

Engineering Contradiction:
Improvesterility during transferVSAvoidtransfer operation simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The docking system provides an intermediary sealed connection between the isolator and preparation container, allowing powder transfer to occur through this sealed interface. This eliminates the need to open the isolator lid during transfer, as the docking connection maintains sterility while enabling direct material transfer.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 system ensures safe and efficient transfer of pharmaceutical powders with OEL specifications of ≤ 0.1 µg/m³ and OEB value of 5, enabling vertical docking without operator handling, no weight limits, and eliminating the need for pre-sterilization of the interface, thus meeting stringent safety and contamination control standards.

Implementation Method 1

a compensator (7), through which the transfer of pharmaceutical agents from the isolator to the mixing container takes place and which is designed to compensate for length differences

Methodology Applied
Scientific EffectAxial deformation: Deformation

Implementation Method 2

it is obvious that during transfer, the powder should be moved vertically downwards into the next processing zone

Methodology Applied
Scientific EffectGravity: Gravitation

Data Source

PatentEP3524365B9Docking system
Publication Date: 2022.10.19 PHARMATEC GMBH
  • EP3524365B9 patent drawingFigure 1A~1B
  • EP3524365B9 patent drawingFigure 2A~2B
  • EP3524365B9 patent drawingFigure 3A~3B

AI summary

Docking system for transferring powdered pharmaceuticals from an isolator to a mixing container, comprising a B-part that can be attached to the opening of the mixing container and an A-part that is arranged on the isolator. The A- and B-parts can be connected to each other by means of connecting elements. A compensator (7), designed for length compensation, can be attached to the opening of the respective mixing container. The compensator can be attached to the A-part at its opposite end face. The opening of the base flange of the A-part can be closed with an insulator cover (14) and a flange cover (11) that can be attached to the base flange (10) of the B-part. To compensate for length changes in the compensator (7) that occur when a mixing container is docked to the isolator, a lifting system is arranged between a support and a support plate (6).