Tapered Sterile Transfer Bag for Isolator RTP Systems

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Solution Overview

Problem

The existing methods for transferring sterile goods from a container to an isolator often result in contamination due to contact with non-sterile surfaces, known as the 'Ring of Concern', and require operator intervention within the isolator, making the process cumbersome and risky.

Innovation Solution

A container design with a tapered bag section that widens into a funnel shape, allowing a transfer tube to be inserted without operator intervention, which bridges the 'Ring of Concern' and ensures complete transfer of goods into the isolator by narrowing towards the closed end, preventing retention of material and ensuring sterility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a transfer tube is inserted into the container to prevent contact with non-sterile surfaces, then contamination is prevented, but operator intervention within the isolator is still required making the process cumbersome

Engineering Contradiction:
ImprovesterilityVSAvoidoperator intervention
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The transfer tube is pre-positioned within the container before docking, with its free end initially located in a first position outside the container opening. After docking, the transfer tube is moved to a second position where its free end extends into the container interior, allowing goods to be transferred through the tube without operator intervention within the isolator.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The transfer tube serves as an intermediary element that bridges the sterile interior of the container and the isolator environment. It allows goods to be transferred through a controlled path that prevents contact with non-sterile surfaces while enabling operation from outside the isolator.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If goods are transferred directly from container to isolator, then the process is simple, but contact with non-sterile surfaces causes contamination

Engineering Contradiction:
Improvetransfer simplicityVSAvoidsterility
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The transfer tube acts as a sterile intermediary pathway between the container and isolator. Goods are conveyed through this dedicated tube rather than being directly exposed to the isolator environment, preventing contact with non-sterile surfaces while maintaining transfer simplicity.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The transfer tube is made of flexible material that allows it to be maneuvered between different positions (inside and outside the container) while maintaining its sealing function. This flexibility enables the tube to adapt to the docking configuration while preserving sterility.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If the bag section has a narrow opening to fit the transfer tube, then sterility is maintained, but material retention in the container increases

Engineering Contradiction:
ImprovesterilityVSAvoidmaterial retention
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The bag section is designed with a dynamically adjustable opening that can widen to accommodate the transfer tube during transfer operations, then return to a narrower configuration. This dynamic behavior allows the opening to adapt between sterility maintenance (narrow) and complete emptying (wide) requirements.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The bag section is divided into different functional zones: a first section with a narrower opening for maintaining sterility, and a second section with a wider opening for complete material discharge. This segmentation allows each zone to optimize for its specific function while working together to achieve both sterility and complete transfer.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3613442B1Container for the transport and transfer of sterile bulk material into an insulator
Publication Date: 2021.02.24 ATEC PHARMATECHN
  • EP3613442B1 patent drawingFigure 1~2
  • EP3613442B1 patent drawingFigure 3
  • EP3613442B1 patent drawingFigure 4~6

AI summary

The invention relates to a container (10; 12) for transferring sterile, free-flowing material, in particular cleaned and sterilized small items such as stoppers for infusion bottles and vials, through a rapid transfer port (RTP) system (18) into an isolator (16). The container (10; 12) comprises a flexible, tube-like pouch section (24; 26) with a closed end (28) and an open end (34), as well as a container-side section (22) of the RTP system (18) tightly connected to the open end (34), which can be docked to a complementary isolator-side section (20) of the RTP system (18) for transferring the material. According to the invention, the container (10; 12) comprises a container section (62) whose inner cross-section tapers towards the closed end (28) and which is formed at least partially by the tubular flexible bag part (26).