Sterilization Challenge Pack Restrictive Flow Path
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Solution Overview
Problem
Current sterilization challenge packs face difficulties in ensuring that the innermost regions of bundled items, such as towels, are adequately sterilized due to the resistance of steam in reaching these areas, necessitating an improved design to verify sterilization efficacy.
Innovation Solution
A sterilization challenge pack with a base tray and dual covers, featuring a restrictive flow path through an unsealed portion and notch, allowing controlled entry of gaseous sterilization media into chambers containing biological and chemical indicators, which are in fluid communication, mimicking the conditions within a bundle of towels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If steam is introduced to sterilize bundled towels, then sterilization is achieved, but the innermost regions may not be sufficiently subjected to steam due to resistance
Solution Approach 1:
The patent creates a challenge pack that copies the internal structure of bundled towels using a container with an interior space. This replica structure allows steam flow paths to be simulated and measured, enabling verification of whether steam can effectively reach the innermost regions of actual bundled towels during sterilization.
Solution Approach 2:
The challenge pack serves as an intermediary device between the steam sterilization system and the bundled towels. By placing the challenge pack in the sterilization cycle, it acts as a mediator that experiences the same steam exposure conditions as the towels, allowing indirect measurement and verification of steam penetration efficacy.
2Measurement precision
If a challenge pack is designed to simulate bundle conditions, then sterilization verification is improved, but the device complexity increases
Solution Approach 1:
The challenge pack is segmented into distinct functional components: a container providing the interior space, a lid with a specific opening configuration, and an indicator system. This segmentation allows each component to be optimized independently while maintaining overall simplicity and functionality.
Solution Approach 2:
The challenge pack incorporates an indicator that changes color or appearance in response to steam exposure. This visual indicator provides simple, direct feedback on whether steam has reached the interior space, enabling easy verification of sterilization efficacy without complex measurement systems.
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 design ensures effective verification of sterilization processes by providing a restrictive flow path that closely mimics the conditions within a bundle of towels, ensuring accurate sterilization efficacy, as demonstrated by positive biological activity in tested autoclave cycles.
Implementation Method 1
The unsealed portion and the notch provide a restrictive flow path into the chamber
Implementation Method 2
positive biological activity in tested autoclave cycles
Data Source
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AI summary
A sterilization process challenge pack including a base tray, a first cover, and a second cover is configured to provide a restrictive flow path for gaseous sterilization medium to test the efficacy of a sterilization process. The base tray includes at least one chamber containing a biological indicator and/or chemical indicator. The first cover including a notch is configured to cover the at least one chamber. The second cover is attached to peripheral surfaces of the base tray except at an unsealed portion. A flow path through the unsealed portion and the notch in the first cover provides the only fluid communication between an external environment and the at least one chamber.