Pharmaceutical Preparation Device with Sterile Filtration

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Solution Overview

Problem

Current methods for preparing pharmaceutical or biopharmaceutical substances are time-consuming and require careful handling to achieve precise volumes, concentrations, and components, especially under high-purity and sterile conditions, which is not efficiently addressed by devices designed for beverage preparation.

Innovation Solution

A device comprising a preparation container with ingredients, a storage container for a fluid that can be fed in a monitored manner via a feed line, and a receiving container, equipped with sterile or virus filters, allowing for quick, reliable, and easy preparation of pharmaceutical or biopharmaceutical substances in small to medium volumes under high-purity and sterile conditions, with options for cartridge or pad preparation containers and flexible arrangements for multiple containers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If devices designed for beverage preparation are used, then the preparation process becomes simpler, but the purity and sterility conditions cannot be met

Engineering Contradiction:
Improvepreparation process simplicityVSAvoidsterility and purity conditions
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent employs disposable preparation containers (capsules or cartridges) that are pre-filled with pharmaceutical substances. These single-use containers eliminate the need for complex sterilization procedures while ensuring sterility and purity, as each container is sterile by design and discarded after one use, combining ease of operation with reliable sterility conditions.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Manufacturing precision

If manual preparation methods are used, then precise volumes and concentrations can be achieved, but the preparation time increases significantly

Engineering Contradiction:
Improvevolume and concentration precisionVSAvoidpreparation time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The pharmaceutical substances are pre-filled into preparation containers (capsules or cartridges) with precise dosing and concentrations before use. This preliminary action ensures that when the container is used, the precise volume and concentration requirements are already met, eliminating the need for time-consuming manual measurement and mixing while maintaining high precision.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The preparation container is designed to automatically deliver the correct volume and concentration of pharmaceutical substance when activated. The system requires minimal operator intervention, as the pre-configured container self-regulates the preparation parameters, thereby reducing preparation time while maintaining precision.

Inventive Principle:
Principle #25Self-service

3Quantity of substance

If small volumes of pharmaceutical substances are prepared, then the required precision is high, but the handling complexity increases

Engineering Contradiction:
Improvesmall volume preparationVSAvoidhandling complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The pharmaceutical substance is segmented into individual single-use preparation containers, each containing a specific small volume with pre-determined precision. This segmentation allows each container to be optimized for its specific dosage requirements without requiring complex handling procedures for small volumes, as each unit is self-contained and sterile.

Inventive Principle:
Principle #1Segmentation

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

Enables rapid, reliable, and easy preparation of pharmaceutical or biopharmaceutical substances in precise volumes and concentrations, suitable for both small and larger amounts, ensuring sterility and virus-free conditions through the use of filters and controlled fluid feeding and mixing processes.

Implementation Method 1

equipped with sterile or virus filters, allowing for quick, reliable, and easy preparation of pharmaceutical or biopharmaceutical substances under high-purity and sterile conditions

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Data Source

PatentUS10786432B2Use of a device and a method for preparing mixtures of pharmaceutical substances
Publication Date: 2020.09.29 SARTORIUS STEDIM BIOTECH GMBH
  • US10786432B2 patent drawing
  • US10786432B2 patent drawing
  • US10786432B2 patent drawing

AI summary

A method for the preparing mixtures of pharmaceutical or biopharmaceutical substances (11, 11″) includes arranging a preparation container (3, 3′, 3″) already made up with ingredients in a receptacle (2) of a device (1, 1′, 1″) feeding a fluid (10) from a storage container (4, 4″) into the preparation container (3, 3″) via a feed line (6), preparing the ingredients with the fluid (10, 10″) into a substance mixture (11, 11″), and removing the substance mixture (11, 11″) from the preparation container (3, 3′, 3″) into a receiving container via a discharge line (12, 12′, 12″). A device also is provided for carrying out the method.