Biological Indicator Cap Structure for Ampule-Free Liquid Exchange
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Solution Overview
Problem
Existing biological indicators for liquid-chemical decontamination systems face challenges in efficiently introducing and removing liquid decontaminants due to the presence of a glass ampule, which requires excessive force to break and impedes accurate microbial outgrowth assessment.
Innovation Solution
A biological indicator design without an ampule, featuring a cap with a liquid chamber and a spike-like insert to facilitate easy introduction and removal of liquid decontaminants, allowing for accurate microbial outgrowth assessment by incorporating a growth medium directly in the cap.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a glass ampule is used to contain the growth medium, then the ampule is robust enough to avoid breakage during transportation, but a greater force is required to break the ampule at the desired time
Solution Approach 1:
The cap is divided into a first portion (outer cap) and a second portion (inner cap) that can be separated from each other. The growth medium is contained in the second portion, which can be detached from the first portion to allow access to the growth medium without requiring forceful breaking of a robust container.
Solution Approach 2:
The growth medium is extracted from a separate robust ampule and integrated directly into the cap structure. This eliminates the need for a separate breakable ampule while maintaining the protective function during transportation through the removable second portion of the cap.
2Reliability
If a glass ampule is used to contain the growth medium, then the growth medium is protected during transportation, but the ampule impedes accurate microbial outgrowth assessment
Solution Approach 1:
The growth medium is extracted from the ampule and integrated into the cap structure, eliminating the ampule barrier that interferes with microbial outgrowth assessment. The second portion of the cap containing the growth medium can be positioned optimally for observation without the obstruction of a separate ampule container.
Solution Approach 2:
The growth medium container is merged with the cap structure itself rather than being a separate ampule. This integration allows the biological indicator to function as a unified device where the growth medium is readily accessible for microbial outgrowth assessment while still being protected during transportation through the removable cap portion.
3Reliability
If an ampule is used to contain the growth medium, then the growth medium is contained securely, but liquid decontaminants cannot be efficiently introduced and removed
Solution Approach 1:
The cap is segmented into two separable portions, creating an open architecture that allows liquid decontaminants to be efficiently introduced and removed. The second portion containing the growth medium can be detached to facilitate rapid liquid exchange while the growth medium remains securely contained within the second portion when attached.
Solution Approach 2:
The cap structure serves multiple functions: it contains the growth medium securely when assembled, allows efficient liquid decontaminant exchange when the second portion is detached, and provides a protective barrier during transportation. This multi-functional design eliminates the need for separate ampule and cap structures.
Data Source
AI summary
A biological indicator (100) for use in a liquid-chemical decontamination system is disclosed. The biological indicator may include a housing (102) and a cap (106) coupled to the housing. The cap may comprise a liquid chamber and at least two ports. One of the ports may connect to a liquid passage in the cap such that liquids such as liquid-chemical decontaminants may be introduced and removed from the biological indicator via this port.


