Sterile Transfer Interface with Disposable Sampling Elements

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Solution Overview

Problem

Existing systems for transferring chemical, pharmaceutical, and biological materials into or out of disposable containers, such as bioreactors, face challenges in maintaining sterility and preventing contamination during sampling or material addition, particularly due to the risk of microorganisms entering the container.

Innovation Solution

A disposable container system with a transfer interface featuring extensible sampling elements, a locking mechanism, and a septum design that ensures sterile sampling by preventing the transfer elements from being reused and maintaining sterility through a biasing element and a resealing septum, allowing for controlled and aseptic extraction or addition of materials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transfer elements are made extensible for sampling, then sampling capability is improved, but risk of contamination increases

Engineering Contradiction:

Improvesampling capabilityVSAvoidcontamination risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The transfer interface is divided into separate sterile and non-sterile zones using aseptically removable transfer elements. These elements can be extended into the sterile container interior for sampling, then retracted and removed without contaminating the container. This segmentation allows sampling operation while maintaining sterility barrier.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The transfer elements act as intermediaries between the non-sterile external environment and the sterile container interior. They can be sterilized separately and inserted through the septum to transfer samples or materials without direct exposure of the container interior to contaminants.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If the container is designed for multiple uses, then productivity is improved, but maintaining sterility becomes more difficult

Engineering Contradiction:

Improvenumber of usesVSAvoidsterility maintenance

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The transfer elements are designed to be removably connected to the transfer interface, allowing them to be extracted after use. This extraction prevents cross-contamination between multiple uses, as each transfer element can be sterilized independently or replaced, enabling the container system to be reused multiple times while maintaining sterility.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The transfer elements and interface are pre-sterilized before use through autoclaving, gamma irradiation, or other sterilization methods. This preliminary sterilization action ensures that the system is sterile before multiple uses begin, and the removable design allows re-sterilization between uses to maintain reliability.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If a septum is used for sealing, then sterility is improved, but complexity of the system increases

Engineering Contradiction:

ImprovesterilityVSAvoidsystem complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

A flexible septum made of elastomeric material is used to seal the container opening. This thin film structure provides effective sterility barrier while allowing transfer elements to penetrate through it for sampling operations. The flexibility enables repeated penetration and resealing without compromising sterility or requiring complex mechanical components.

Inventive Principle:

Principle #30Flexible shells and thin films

4Loss of time

If transfer elements are reusable, then loss of time is reduced, but contamination risk increases

Engineering Contradiction:

Improvesterilization timeVSAvoidcontamination risk

Core Design Contradiction:

Loss of timeVSObject-affected harmful factors

Solution Approach 1:

The transfer elements are designed as disposable components that can be sterilized and used once, then discarded. This approach eliminates the risk of contamination from repeated use of the same elements, as each element is fresh and sterile. The low cost of these simple components makes the disposable approach economically viable, reducing sterilization time and contamination risk.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Data Source

PatentUS12017228B2Device having multiple sterile fluid paths integrated onto a disposable container

Publication Date: 2024.06.25 SARTORIUS STEDIM BIOTECH GMBH

AI summary

Systems and a method for transferring chemical, pharmaceutical, and/or biological material into or out of a container are provided. One system comprises a disposable container having at least one port for accessing the interior of the container, the port comprising at least one connecting protrusion extending parallel to the container. The system further comprises a transfer interface connectable to the port. The transfer interface comprises a plate, and at least one connecting flange extending from the plate, the connecting flange to be arranged under the respective connecting protrusion to connect the transfer interface to the port, such that when the transfer interface is connected to the port the plate is parallel to a surface of the container.