Integrated Sterility Testing Unit with Movable Sealing Mechanism
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Solution Overview
Problem
Existing sterility and bioburden testing methods are complex, labor-intensive, and generate significant waste, with high risks of contamination and handling errors, and lack automation capabilities.
Innovation Solution
A sample preparation unit with a housing body and movable part that allows selective fluid transfer and sealing, integrated ports for efficient handling and reduced contamination risk, and a device with integrated sample preparation units for streamlined setup and reduced waste, featuring a rotatable ring member for intuitive operation and easy disconnection of tubing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If external separate connections of numerous components via plural segments of tubing are used, then fluid transfer functionality is achieved, but device complexity and risk of handling mistakes increase
Solution Approach 1:
The patent integrates multiple separate components (containers, pumps, valves, filters) into a single integrated sample preparation unit where the housing body contains internal chambers, membranes, and fluid pathways. This merging eliminates the need for external tubing connections between multiple separate components, thereby reducing device complexity and minimizing handling mistakes.
Solution Approach 2:
The housing body serves multiple functions simultaneously: it acts as a container for the sample, houses the membrane filter, contains the growth medium, and provides integrated fluid pathways. This multi-functionality reduces the number of separate components needed, simplifying the overall system while maintaining full functionality.
2Ease of operation
If numerous separate components and tubing segments are used, then fluid transfer is enabled, but manual work and labor cost increase
Solution Approach 1:
By combining multiple operational components into a single integrated unit, the patent reduces the number of manual assembly and disassembly steps required. The unified design allows for easier operation with less manual intervention, thereby reducing labor costs and increasing productivity.
3Reliability
If all system elements are discarded after use, then sterility is maintained, but volume and mass of waste increase
Solution Approach 1:
The patent divides the system into disposable and reusable components. The sample preparation unit (housing body with internal components) is designed as a disposable single-use element that can be discarded after one use, while more expensive components like the incubator and detection systems are reusable. This segmentation maintains sterility by eliminating cross-contamination risks while minimizing overall waste by preserving valuable equipment.
4Reliability
If the canister apparatus is designed for disposable use, then sterility is ensured, but the apparatus becomes bulky and unpractical to handle
Solution Approach 1:
The patent integrates all necessary components (sample chamber, membrane, growth medium reservoir, fluid pathways) into a single compact unit that eliminates the need for external tubing and separate containers. This integrated design maintains sterility while significantly improving handling practicality by creating a compact, self-contained apparatus that is easier to manipulate during incubation and detection.
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 solution simplifies the handling process, reduces contamination risks, and enables automation, while minimizing waste and labor costs, enhancing the efficiency and reliability of sterility testing.
Implementation Method 1
the solution to be tested is flowed through the cylinder having a microporous membrane filter which strains microorganisms from the solution and concentrates them on the microporous filter
Implementation Method 2
with the filter being vented, during this step, through a vent having a hydrophobic filter to prevent intake of bacteria
Data Source
AI summary
Sample preparation unit, preferably for sterility testing: a housing body including at least two ports adapted to serve as fluid inlet and/or fluid outlet, a membrane support, and a lid part such that a membrane chamber is defined adjacent said membrane support. One of at least two ports is arranged so as to allow a fluid transfer to/from a first volume of the membrane chamber at a position upstream of a membrane to be placed on the membrane support, and the other ports arranged to allow fluid transfer to/from a second volume of said membrane chamber at a position downstream of a membrane to be placed on said membrane support. A movable part is provided on housing body such that the movable part and housing body are movable relative to each other, selectively interrupting/establishing fluid transfer between at least one of two ports and the membrane chamber.