Automated Swabbing Device for Consistent Cleaning Validation

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Solution Overview

Problem

In biotechnology, pharmaceutical, and medical-device industries, surface cleanliness validation is challenging due to human error and inconsistency in swabbing, particularly in hard-to-reach areas, leading to risks of false results and dangerous confined space entries.

Innovation Solution

An electro-mechanical device with a horizontally movable inner shaft, adjustable housing for a rotatable swab, and electronic controller to automate the cleaning validation process, ensuring consistent surface pressure and defined sampling patterns without human intervention, allowing for safe operation from a distance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual swabbing is performed by trained personnel, then cleaning validation can be conducted, but human error and inconsistency lead to false results

Engineering Contradiction:

Improvecleaning validation accuracyVSAvoidswabbing consistency

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The automated swabbing device performs the cleaning validation task autonomously without requiring human intervention during the actual swabbing process. The system self-regulates pressure, movement speed, and swabbing pattern, eliminating human error and inconsistency while maintaining reliable validation results

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces the manual mechanical swabbing process with an automated electro-mechanical system that uses motors, sensors, and controllers to execute the swabbing task. This substitution eliminates the variability inherent in human-operated manual swabbing while maintaining the essential cleaning validation function

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If telescoping pole is used for swabbing, then confined space entry is avoided, but the risk of not properly performing sampling increases due to distance

Engineering Contradiction:

Improveconfined space safety riskVSAvoidswabbing accuracy

Core Design Contradiction:

Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The automated swabbing device acts as an intermediary between the operator and the confined space environment. It can be positioned inside vessels or pipes through extensions while being controlled remotely, maintaining both safety distance and sampling precision through automated control mechanisms

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The manual mechanical control via telescoping pole is replaced with an automated electro-mechanical system that can be positioned remotely. The automation ensures precise swabbing execution regardless of the distance between the operator and the sampling location, eliminating the precision loss associated with manual remote operation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If more training is provided to personnel, then swabbing skill improves, but time and money costs increase significantly

Engineering Contradiction:

Improveswabbing skill levelVSAvoidtraining time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The automated system eliminates the need for extensive human training by performing the swabbing task autonomously. The system comes pre-programmed with proper swabbing techniques, pressure application, and movement patterns, requiring no skill development time while delivering consistent results

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces the human operator's manual skills with an automated electro-mechanical system. This substitution eliminates the time and resource investment required for training personnel while maintaining or improving the quality of the swabbing operation through consistent automated execution

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS10576511B2Automatic cleaning validation swabbing devices, methods, and systems

Publication Date: 2020.03.03 SWABBOT SOLUTIONS LLC

AI summary

In some variations, this invention provides an electro-mechanical device for automated cleaning validation of a selected surface. The device moves a wetted swab over a cleaned surface to recover any remaining soil left over from the cleaning process. The device accepts a standard sampling swab that has been wetted with the required liquid solution. The device maintains constant swab pressure to ensure maximum recovery of soil or contaminants. The device includes an electronic controller for adjusting the movement of parts to effectively validate cleaning of the selected surface. The surface to be validated may be a substantially flat surface, or rounded. The surface may be contained within a vessel, reactor, a pipe, tank, or other equipment. The device may be disposed on an extension arm to allow the device to be positioned appropriately, without the need for a person to be close to the device for validation.