Air Removal Test Strip for Sterilizer Verification
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Solution Overview
Problem
Current air removal test systems for prevacuum steam sterilizers are labor-intensive, costly, and create waste due to the need for disposable test packs, and existing indicators do not accurately verify adequate air removal during sterilization cycles.
Innovation Solution
A reusable air removal test system comprising a specimen holder and a test strip configured to simulate ANSI/AAMI/ISO 11140-4:2007 and 11140-5:2007 test methods, using a thermally conductive base element, wicking element, and coated paper with a window to indicate adequate air removal through color change, which is specific to different sterilization cycle parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional Bowie-Dick test packs with cotton towels are used, then air removal verification is achieved, but labor intensity and preparation time increase significantly
Solution Approach 1:
The patent employs disposable test strips that are single-use indicators designed to be discarded after one sterilization cycle. These strips eliminate the need for repeated preparation of reusable test packs, as each strip is pre-configured with the necessary materials and indicator chemicals to perform the air removal verification function once, then disposed of. This resolves the contradiction by accepting the disposability of the testing component to dramatically reduce preparation time and labor for subsequent tests.
Solution Approach 2:
The test strips are pre-configured during manufacturing with the indicator chemicals, wicking elements, and structural components needed to perform the air removal verification. This preliminary preparation eliminates the need for users to assemble test packs from individual components each time a test is needed. The strips arrive ready-to-use, with all materials pre-positioned and pre-treated, thus resolving the contradiction between reliable verification and time-consuming preparation.
2Ease of operation
If disposable test packs are used, then air removal testing is simplified, but cost and waste generation increase
Solution Approach 1:
The patent extracts only the essential functional components needed for air removal verification from the traditional test pack assembly. Instead of disposing of entire test packs with multiple layers of cotton towels and complex structures, the invention uses minimal test strips containing only the necessary indicator chemicals and wicking materials. This extraction principle resolves the contradiction by maintaining operational simplicity while dramatically reducing material waste through selective removal of non-essential components.
Solution Approach 2:
The test strips use localized concentrations of indicator chemicals and wicking materials only where needed for the specific verification function, rather than using uniform materials throughout the entire test pack. This localized approach allows the testing function to be performed with minimal material consumption, resolving the contradiction between ease of operation and waste reduction by concentrating resources only where functionally necessary.
3Temperature
If general temperature indicators are used, then temperature monitoring is provided, but specific air removal verification is not achieved
Solution Approach 1:
The test strips incorporate indicator chemicals with specific response characteristics tailored to detect the presence or absence of air during steam sterilization. Rather than using general-purpose temperature indicators that merely show heat exposure, these indicators are locally optimized to change state specifically when air removal conditions are met, resolving the contradiction between temperature monitoring and precise air removal verification.
Solution Approach 2:
The patent employs color-changing indicator chemicals that provide visual confirmation of air removal status. These indicators undergo specific color transitions when exposed to steam under different air removal conditions, enabling precise detection of whether air was successfully evacuated from the sterilizer chamber. This color change mechanism resolves the contradiction by providing both temperature indication and specific air removal verification through a single integrated system.
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
The system provides a cost-effective and efficient means to verify adequate air removal during sterilization cycles, reducing labor and waste while producing results equivalent to traditional test packs, ensuring effective sterilization by confirming air removal in prevacuum sterilizers.
Implementation Method 1
a wicking element positioned at least in part in contact with the solid indicator chemical
Implementation Method 2
a base element formed from a thermally conductive material having a length and a width and a recess formed therein
Data Source
AI summary
An air removal test system for verifying adequate air removal during a sterilization cycle of a pre-vacuum type sterilizer includes specimen holder and a test strip. The test strip includes a solid indicator chemical, which liquefies and travels along a wicking element during the sterilization cycle. The test strip is configured to verify adequate removal of air during the sterilization cycle by displaying a color change through a window.