Sterile Solution Container Filling With Pre-Sterilized Cartridges

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Solution Overview

Problem

Conventional methods for manufacturing sterile solution-filled containers face challenges such as high capital costs, degradation of solution formulations, and the risk of contamination during terminal sterilization or aseptic filling processes, which are inefficient and costly.

Innovation Solution

A method and system for producing sterile solution-filled containers using a cartridge assembly with a filter assembly and connection line, where solution is pumped through a filter and reservoir before filling containers, and the containers are sealed and separated while maintaining a seal, ensuring sterility without the need for specialized barrier systems.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If terminal sterilization process is used to produce sterile solution-filled containers, then sterility is achieved, but capital costs and space requirements increase significantly

Engineering Contradiction:

Improvesterility assuranceVSAvoidcapital expenditure and space requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs single-use pre-sterilized cartridges that are discarded after one use, eliminating the need for expensive, complex, and space-consuming autoclaves. The disposable cartridge approach provides sterility assurance while dramatically reducing capital expenditure and facility space requirements.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The cartridges are pre-sterilized and pre-filled in a controlled manufacturing environment before use. This preliminary sterilization action transfers the sterility assurance requirement from the point-of-use facility to the manufacturing process, allowing the end-user facility to operate without expensive sterilization equipment.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If terminal sterilization process is used, then sterility is achieved, but solution formulation degradation occurs

Engineering Contradiction:

Improvesterility assuranceVSAvoidsolution formulation stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The solution is sterilized and filled into containers during the pre-manufacturing process before the product reaches the end-user. This preliminary action ensures sterility is achieved without subjecting the solution to high-temperature autoclaving at the point of use, thereby preserving solution formulation stability and preventing degradation.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If aseptic filling process is used in extremely high-quality environment, then sterility is maintained, but equipment cost and procedural complexity increase

Engineering Contradiction:

Improvesterility assuranceVSAvoidequipment cost and environmental control requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses pre-sterilized disposable cartridges that eliminate the need for expensive aseptic filling equipment and complex environmental control systems. The single-use nature of the cartridges ensures sterility without requiring the end-user facility to maintain extremely high-quality environments or invest in costly aseptic processing equipment.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Reliability

If conventional terminal sterilization or aseptic filling is used, then sterility is achieved, but production efficiency decreases

Engineering Contradiction:

Improvesterility assuranceVSAvoidproduction efficiency

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The cartridges are pre-filled and pre-sterilized during manufacturing, allowing for high-speed automated production. This preliminary action transfers the time-consuming sterilization and filling operations to the manufacturing phase, enabling rapid deployment at the end-user facility and significantly improving overall production efficiency.

Inventive Principle:

Principle #10Preliminary action

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

This approach enables efficient, cost-effective production of sterile containers with high sterility assurance, reducing the risk of contamination and maintaining solution integrity, while eliminating the need for expensive isolators and complex environmental controls.

Implementation Method 1

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Data Source

PatentUS12384585B2Method and system for producing sterile solution filled containers

Publication Date: 2025.08.12 BAXTER INT INC

AI summary

A method for producing sterile solution-filled containers includes positioning a cartridge onto a filling machine. The cartridge includes a plurality of containers, a filter assembly, and a connection line in fluid communication with the filter assembly. Each of the plurality of containers includes a volume and a stem in fluid communication with the volume and in fluid communication with the connection line. The method includes coupling the cartridge to a feed line in fluid communication with a mix tank, activating a pump coupled to the feed line, and at least partially filling one or more of the volumes associated with the plurality of containers by pumping fluid through the feed line, the filter assembly, and the connection line to create one or more at least partially filled containers. Further, the method includes sealing and separating each of the filled and sealed containers from the connection line.