Sterilization Chamber Integration Kit for Biological Indicator Verification
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Solution Overview
Problem
Current methods for verifying biological indicators used in sterilization processes are complex, costly, and require specialized equipment, making them inaccessible and inefficient for routine use.
Innovation Solution
An integration kit that allows a standard sterilization machine to be converted into a Biological Indicator Evaluator Resistometer (BIER) capable of characterizing biological indicators without altering the machine's functionality, enabling rapid conversion and efficient bioindicator testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If specialized BIER apparatus are used for verifying biological indicators, then measurement precision and reliability are improved, but device complexity and cost increase significantly
Solution Approach 1:
The sterilization chamber is designed to serve dual purposes: functioning as both a standard sterilization device and a BIER apparatus for biological indicator verification. The same chamber that sterilizes medical devices can also perform bioindicator characterization, eliminating the need for separate specialized equipment and reducing overall system complexity while maintaining measurement precision
Solution Approach 2:
The patent combines the BIER functionality with the standard sterilization chamber by integrating indicator holders and sealing mechanisms into the existing chamber structure. This merging of functions allows the sterilization apparatus to perform both sterilization and bioindicator verification, reducing device complexity and cost while preserving measurement capabilities
2Adaptability or versatility
If dedicated BIER machines are purchased and installed, then bioindicator verification capability is achieved, but acquisition and maintenance costs increase
Solution Approach 1:
The sterilization chamber is designed to serve dual purposes: functioning as both a standard sterilization device and a BIER apparatus for biological indicator verification. The same chamber that sterilizes medical devices can also perform bioindicator characterization, eliminating the need for separate specialized equipment and reducing overall system complexity while maintaining measurement precision
Solution Approach 2:
The patent combines the BIER functionality with the standard sterilization chamber by integrating indicator holders and sealing mechanisms into the existing chamber structure. This merging of functions allows the sterilization apparatus to perform both sterilization and bioindicator verification, reducing device complexity and cost while preserving measurement capabilities
3Measurement precision
If complex BIER apparatus are deployed, then biological indicator characterization accuracy is improved, but ease of operation and accessibility deteriorate
Solution Approach 1:
The biological indicator verification process is divided into discrete, manageable steps: placing indicators in holders, sealing the chamber, running sterilization cycles, and retrieving results. This segmentation simplifies the operational workflow, making the process accessible to standard sterilization operators without requiring specialized BIER equipment training
Solution Approach 2:
The sterilization chamber is designed to serve dual purposes: functioning as both a standard sterilization device and a BIER apparatus for biological indicator verification. The same chamber that sterilizes medical devices can also perform bioindicator characterization, eliminating the need for separate specialized equipment and reducing overall system complexity while maintaining measurement precision
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
Enables precise and efficient characterization of biological indicators using a standard sterilization machine, reducing costs and simplifying the process, while maintaining performance and reliability.
Implementation Method 1
In the case of steam sterilisation, for example, the reaching of the sterilisation temperature does not necessarily imply the presence of saturated steam in (direct or indirect) contact with the microorganisms to be inactivated
Implementation Method 2
or ethylene oxide or hydrogen peroxide in 'cold' chemical processes
Implementation Method 3
which, during use, extends inside the sterilisation or decontamination chamber (2) and which can be selectively put in fluid communication therewith so as to allow the passage therefrom and thereto of a sterilising agent present inside the sterilisation or decontamination chamber (2)
Implementation Method 4
The integration kit also comprises a first sealing means (14) and a second sealing means (28) which are mutually movable inside the guide channel (20)
Data Source
AI summary
The present invention relates to an integration kit for a normal sterilisation machine (1) comprising a sterilisation chamber (2) configured to contain the products to be sterilised, the integration kit comprising:-an indicator loading element (10) which is insertable and removable from said sterilisation chamber (2) following a sterilisation process; and-a bioindicator guide channel (20) configured to removably receive said indicator loading element (10) therein, the guide channel (20) having a first portion (22a) connectable outside of the sterilisation chamber (2) through a through-hole and a second portion (22b, 22c) which, during use, extends inside the sterilisation chamber (2) and which can be selectively put in fluid communication therewith so as to allow the passage therefrom and thereto of a sterilising agent present inside the sterilisation chamber (2). The invention also relates to a method for characterising biological indicators used in product sterilisation processes.