Reference Test Body for Microbial Barrier Verification
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Solution Overview
Problem
Existing methods for testing microbial barrier properties of sterilized medical products under pressure variations lack a reliable way to verify consistent test conditions across different test cycles, making it difficult to compare and ensure the validity of the results.
Innovation Solution
A reference test body with a cavity containing a nutrient medium and a perforated cover is used to collect and compare the number of germs penetrating through controlled openings, ensuring consistent test conditions by maintaining the same number of germs across multiple test cycles, thereby identifying deviations that indicate varying test conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If test conditions are not monitored across different test cycles, then test complexity is reduced, but measurement precision and reliability of test results deteriorate
Solution Approach 1:
A reference test body is introduced as a simplified copy model that replicates the essential characteristics of the product being tested. This reference body contains a cavity with nutrient medium and a standardized cover with openings, serving as a benchmark to verify test conditions. By comparing results from the reference body against established parameters, the system enables precise verification of test conditions without requiring complex monitoring equipment in the main test chamber.
Solution Approach 2:
The reference test body utilizes controlled parameter changes to verify test conditions. Specifically, the number of germs collected on the reference test body is measured and compared across different test cycles. This parameter (germ count) serves as an indicator of test condition consistency, allowing verification without complex instrumentation while maintaining measurement precision.
2Reliability
If multiple test cycles are conducted without verification, then productivity increases, but reliability of comparative results deteriorates
Solution Approach 1:
The reference test body is prepared in advance with a standardized cavity structure, nutrient medium, and perforated cover before test cycles begin. This preliminary preparation establishes a known baseline that can be quickly compared against subsequent test results, enabling rapid verification of test condition consistency across multiple test cycles without delaying productivity.
Solution Approach 2:
A feedback mechanism is implemented by measuring the number of germs collected on the reference test body after each test cycle and comparing it against expected values. This feedback loop provides immediate verification of test condition consistency, allowing operators to identify deviations and adjust parameters to maintain reliability across increased numbers of test cycles.
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
This approach allows for the consistent verification of test conditions, increasing the reliability and safety of product testing by ensuring that the same conditions are maintained across multiple test cycles, thus improving the meaningfulness of the tests conducted.
Implementation Method 1
a nutrient medium located in the cavity and provided for germs
Data Source
AI summary
A reference test body for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product, wherein the reference test body has a cavity, a nutrient medium, at least one opening, and at least one cover provided with a number of holes and covering the at least one opening. A constancy of test conditions can be monitored in this way. The invention further relates to an associated use, an associated test chamber, and an associated method.