Test Device Cleaning Process Using Segmented Fluid Phases

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Solution Overview

Problem

Existing cleaning processes for test apparatuses, particularly those used for filters and containers, often fail to achieve thorough removal of contaminants like bacteria and viruses, leading to potential contamination during normal operation and increased risk of microbiological contamination.

Innovation Solution

A cleaning process involving the selection of internal volumes for cleaning, using a cleaning fluid followed by partial drainage and subsequent flushing with a different fluid, ensuring complete removal of contaminants and contaminated fluids, while utilizing computer-assisted or computer-controlled switching means to manage the fluid flow and employing cleaning fluids like sodium hydroxide or hydrogen peroxide solutions, and optionally hot steam for sterilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cleaning fluid is used to clean internal volumes, then cleaning effectiveness is improved, but contaminated cleaning fluid remains in the internal volumes causing potential re-contamination

Engineering Contradiction:
Improvecleaning effectivenessVSAvoidresidual contamination
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The cleaning process is segmented into distinct phases: filling with cleaning fluid, draining, flushing with fresh fluid, and final draining. This segmentation ensures that contaminated cleaning fluid is systematically removed and replaced, preventing residual contamination while maintaining cleaning effectiveness through the multi-stage approach.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The internal volumes are pre-filled with cleaning fluid before the actual cleaning action begins. This preliminary filling ensures that all internal surfaces are immediately contacted by the cleaning fluid, maximizing cleaning effectiveness before the fluid is drained and replaced with fresh flushing fluid.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If cleaning fluid is retained in internal volumes after cleaning, then cleaning effectiveness is improved, but the contaminated fluid mixes with subsequent cleaning or flushing fluids

Engineering Contradiction:
Improvecleaning effectivenessVSAvoidcontaminated fluid accumulation
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The process employs periodic action through repeated cycles of filling, draining, and flushing. The switching means periodically changes the state of the system between cleaning fluid introduction, draining, and flushing phases, ensuring that contaminated fluid is systematically removed and replaced without accumulation, while maintaining continuous cleaning effectiveness.

Inventive Principle:
Principle #19Periodic action

3Device complexity

If manual cleaning processes are used, then process complexity is reduced, but cleaning thoroughness and safety are compromised

Engineering Contradiction:
Improveprocess simplicityVSAvoidcleaning thoroughness
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The system performs self-service through automated switching means that control the filling, draining, and flushing operations without manual intervention. The switching means automatically sequences the cleaning fluid introduction and removal, ensuring thorough cleaning while maintaining process simplicity through automation rather than complex manual procedures.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system incorporates feedback mechanisms where the switching means responds to the state of the internal volumes, automatically adjusting the cleaning process. This feedback ensures that cleaning fluid is introduced, drained, and replaced in the correct sequence, maintaining both cleaning thoroughness and process simplicity through automated control.

Inventive Principle:
Principle #23Feedback

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 process ensures improved microbiological cleanliness, prevents residual contaminants, and simplifies the cleaning process, making it safer and more effective than previous methods by ensuring thorough removal of contaminants and reducing the risk of re-contamination.

Implementation Method 1

cleaning the selected internal volumes with a cleaning fluid by a corresponding switching of the switching means

Methodology Applied
Scientific EffectChemical cleaning/dissolution: Solvation

Implementation Method 2

at least partially draining the cleaning fluid left in the selected internal volumes after cleaning

Methodology Applied
Scientific EffectGravitational drainage: Gravitation

Implementation Method 3

flushing the selected internal volumes with a flushing fluid different from the cleaning fluid

Methodology Applied
Scientific EffectFluid flushing/rinsing: Advection

Data Source

PatentUS9174251B2Cleaning process for a test device, computer program product for performing such a process, and test device
Publication Date: 2015.11.03 SARTORIUS STEDIM BIOTECH GMBH
  • US9174251B2 patent drawing
  • US9174251B2 patent drawing
  • US9174251B2 patent drawing

AI summary

A cleaning process is provided for a test apparatus that has a switch, external connections and internal volumes that can come into contact with a fluid from a filter to be tested or a container to be tested. The cleaning process includes selecting one or more internal volumes to be cleaned, cleaning the selected internal volumes with a cleaning fluid by a corresponding switching of the switch, at least partially draining the cleaning fluid left in the selected internal volumes after cleaning, and flushing the selected internal volumes with a flushing fluid different from the cleaning fluid. Also provided are a computer program product for performing the cleaning process, a cleaning apparatus, and a test apparatus for testing filters and containers.