Sterilization Sampling Assembly for Phase-Specific Verification

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Solution Overview

Problem

Conventional resistometer methods for validating sterilization or disinfection systems cannot determine the point, degree, or phase of sterilization or disinfection within a cycle, as biological or chemical indicators remain exposed to the atmosphere throughout the cycle.

Innovation Solution

A sampling assembly that can be positioned inside a sterilization or disinfection system, allowing for temporal sampling throughout the cycle by opening to expose indicators to the atmosphere and then closing to collect a sample, which can be analyzed to verify the sterilization or disinfection process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If biological or chemical indicators remain exposed to the atmosphere throughout the sterilization or disinfection cycle, then verification of the system can be performed, but the point, degree, or phase of sterilization or disinfection cannot be determined

Engineering Contradiction:

Improveverification accuracyVSAvoidtemporal information

Core Design Contradiction:

Measurement precisionVSLoss of information

Solution Approach 1:

The sterilization or disinfection cycle is divided into multiple phases (conditioning, injection, sterilization/disinfection, ventilation), and sampling is performed at specific segments of these phases rather than continuously throughout. This allows determination of which phase achieved sterilization while maintaining verification accuracy.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sampling assembly is pre-configured with biological or chemical indicators before the cycle begins. The assembly is designed to expose indicators to the atmosphere only during specific predetermined phases, allowing temporal information to be captured without requiring continuous exposure throughout the entire cycle.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If a resistometer is used to verify sterilization or disinfection systems, then the system can be validated, but the specific phase or timing of sterilization effectiveness cannot be identified

Engineering Contradiction:

Improvesystem validationVSAvoidcycle phase information

Core Design Contradiction:

ReliabilityVSLoss of information

Solution Approach 1:

The sampling assembly acts as an intermediary device between the sterilization system and the verification process. It selectively exposes indicators to the atmosphere during specific phases and protects them during others, thereby mediating the transfer of temporal information while maintaining system validation reliability.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The sampling assembly transitions between different states (exposed and protected) dynamically during the cycle. The assembly is configured to be exposed to the atmosphere during specific phases and protected during others, allowing the system to adapt the verification process to different cycle phases and capture temporal information.

Inventive Principle:

Principle #15Dynamics

3Ease of operation

If indicators are exposed to the atmosphere throughout the entire cycle, then verification can be performed, but the data cannot map sterilization or disinfection to various phases of the system cycle

Engineering Contradiction:

Improveverification processVSAvoidphase-specific data

Core Design Contradiction:

Ease of operationVSLoss of information

Solution Approach 1:

The verification process is segmented into phase-specific sampling events rather than continuous exposure. Each phase (conditioning, injection, sterilization/disinfection, ventilation) has dedicated sampling opportunities, allowing phase-specific data to be captured while maintaining operational simplicity through automated timing.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sampling assembly performs periodic exposure to the atmosphere at predetermined intervals corresponding to specific phases of the cycle. This periodic action allows phase-specific data to be captured at regular intervals throughout the cycle while maintaining ease of operation through automated timing mechanisms.

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS12318502B2Disinfection process sampling device

Publication Date: 2025.06.03 AMERICAN STERILIZER CO

AI summary

Various examples disclosed relate to a device for use in a disinfection process. The device can include, for example, a sampling assembly capable of a first position and a second position, wherein the sampling assembly is configured to be used inside a sterilization system. The sampling assembly can include a top portion, a bottom portion, at least one seal therebetween such that the top portion and the bottom portion form an airtight compartment when in the first position, a central pin running through the top portion and bottom portion, and an actuator configured to move the sampling assembly between the first position and the second position along the central pin during a portion of the disinfection process, such that the sampling assembly can collect a sample of atmosphere within the disinfection system.