Sterility Sample Prep Device with Movable Piston Chambers

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Solution Overview

Problem

The existing sample preparation methods for sterility and bio-burden testing require extensive manual handling and multiple steps involving the connection and disconnection of external containers, leading to inefficiencies, inaccuracies, and increased risk of contamination.

Innovation Solution

A sample preparation device with movable pistons that separate volumes within the device, allowing for the selective introduction and mixing of substances, reducing the need for external container handling and automating the transfer of growth media and anaerobic generation substances, thereby simplifying the process and enhancing repeatability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If manual handling and multiple steps involving external containers are used, then the sample preparation process can be performed with simple equipment, but the efficiency and productivity are reduced due to extensive manual operations

Engineering Contradiction:
Improvesample preparation efficiencyVSAvoidequipment structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent combines multiple separate containers (growth media container, anaerobic generation substance container, sample preparation device) into a single integrated system. The growth media and anaerobic generation substance are housed in separate chambers within the same device, eliminating the need for multiple external containers and manual connection/disconnection operations, thereby improving productivity while maintaining manageable device complexity

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The sample preparation device is designed to perform multiple functions: it can prepare samples for both aerobic and anaerobic sterility testing using the same device. The device includes interchangeable chambers that can be configured for different testing requirements, reducing the need for multiple specialized devices and improving overall productivity

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If multiple external containers are connected and disconnected, then the process can be performed with flexible equipment, but the risk of contamination increases

Engineering Contradiction:
Improvecontamination riskVSAvoidmanual handling steps
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

By integrating the growth media and anaerobic generation substance containers into the same device as the sample preparation chamber, the patent eliminates multiple connection and disconnection steps. The system remains closed throughout the preparation process, significantly reducing the risk of contamination while requiring fewer manual operations

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces a sealed chamber system with removable seals that acts as an intermediary between the external environment and the sample preparation process. This allows for easy loading and unloading of materials while maintaining a closed, contamination-free environment during the actual preparation steps

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If manual splitting of sample transfer is performed, then the process can be performed with simple equipment, but the accuracy and precision are reduced due to difficulty in achieving perfect equal splitting

Engineering Contradiction:
Improvesample transfer accuracyVSAvoidautomation mechanism
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces a peristaltic pump as an intermediary device that automatically controls the sample transfer and splitting process. The pump provides precise, equal distribution of sample to multiple chambers through controlled fluid delivery, eliminating manual splitting errors while maintaining manageable device complexity through the use of a single automation component

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS10597694B2Sample preparation device and method of preparing a sample for sterility testing
Publication Date: 2020.03.24 MERCK PATENT GMBH
  • US10597694B2 patent drawing
  • US10597694B2 patent drawing
  • US10597694B2 patent drawing

AI summary

A sample preparation device comprising a first chamber containing a first movable piston separating a first volume upstream and a second volume downstream the first piston, a second chamber containing a second movable piston separating a third volume upstream and a fourth volume downstream the second piston, and an inlet to the first volume and an outlet from the first volume. The first volume is connected with the third volume by a first communication path and the second volume is connected with the fourth volume by a second communication path.