Disposable Fluid Transfer Line for Sterile Biopharmaceutical Filling

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current sterile filling processes for biopharmaceutical fluids in the biopharmaceutical field require frequent maintenance and sterilization operations, leading to increased time and costs between filling operations, and are not suitable for high-frequency use.

Innovation Solution

A process and unit for sterile filling that uses a disposable fluid transfer line, allowing internal and external means and elements to be introduced and removed from a sterile chamber without requiring sterilization of the chamber, enabling rapid assembly and disassembly for continuous operation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sterile filling processes are used with reusable components, then sterilization quality is maintained, but maintenance time and costs increase significantly

Engineering Contradiction:

Improvesterilization qualityVSAvoidmaintenance time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent applies the disposable principle by using single-use fluid transfer lines that are discarded after one filling cycle. This eliminates the need for time-consuming sterilization and maintenance of reusable components, directly resolving the contradiction between maintaining sterilization quality and reducing maintenance time. The disposable nature of the transfer line ensures sterility while eliminating maintenance requirements.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent implements discarding of the fluid transfer line after use, rather than attempting to recover and re-sterilize it. This approach maintains sterilization quality for each filling operation while eliminating the time loss associated with sterilization cycles, directly addressing the technical contradiction.

Inventive Principle:

Principle #34Discarding and recovering

2Reliability

If frequent sterilization operations are performed on filling equipment, then sterile quality is ensured, but operational frequency and productivity decrease

Engineering Contradiction:

Improvesterile qualityVSAvoidoperational frequency

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

By using disposable fluid transfer lines, the patent eliminates the need for repeated sterilization operations, thereby maintaining sterile quality while enabling continuous high-frequency filling operations. The disposable nature of the transfer line ensures each operation starts with a sterile state without requiring prior sterilization cycles.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The fluid transfer lines are pre-sterilized during manufacturing before being packaged and stored. This preliminary sterilization action ensures sterile quality is already established before use, eliminating the need for on-site sterilization operations and enabling immediate high-frequency operational use.

Inventive Principle:

Principle #10Preliminary action

3Ease of manufacture

If reusable fluid transfer lines are used, then cost per filling operation decreases, but maintenance and sterilization costs increase

Engineering Contradiction:

Improvecost per filling operationVSAvoidmaintenance and sterilization costs

Core Design Contradiction:

Ease of manufactureVSEase of repair

Solution Approach 1:

The patent applies the disposable principle to the fluid transfer line, making it inexpensive enough to be discarded after single use. This eliminates all maintenance and sterilization costs associated with reusable lines, and the low cost of the disposable line itself makes the overall cost per filling operation competitive.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Reliability

If complex assembly and disassembly operations are performed, then proper sterilization is achieved, but time and operational efficiency decrease

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidassembly and disassembly time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The disposable fluid transfer line is designed as a single-use component that is replaced rather than cleaned or re-assembled. This eliminates time-consuming assembly and disassembly operations for sterilization purposes, while the pre-sterilized nature of the disposable line ensures sterilization effectiveness is maintained.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Data Source

PatentUS12330824B2Unit for the sterile filling of a final basic container with contents designed for the biopharmaceutical field

Publication Date: 2025.06.17 SARTORIUS STEDIM FMT SAS

AI summary

A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.