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

VSEngineering 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

Engineering Contradiction:
Improverobustness of ampuleVSAvoidease of breaking ampule
Core Design Contradiction:
StrengthVSEase of operation

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #2Taking out (Extraction)

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

Engineering Contradiction:
Improveprotection of growth mediumVSAvoidaccuracy of microbial outgrowth assessment
Core Design Contradiction:
ReliabilityVSMeasurement precision

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.

Inventive Principle:
Principle #2Taking out (Extraction)

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.

Inventive Principle:
Principle #5Merging (Combining)

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

Engineering Contradiction:
Improvesecure containment of growth mediumVSAvoidefficiency of liquid decontaminant exchange
Core Design Contradiction:
ReliabilityVSProductivity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentUS12577518B2Biological indicator for use with a liquid sterilant
Publication Date: 2026.03.17 ASP GLOBAL MFG GMBH
  • US12577518B2 patent drawing
  • US12577518B2 patent drawing
  • US12577518B2 patent drawing

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.