Sterility Testing Container with Piercable Barrier Septum
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Solution Overview
Problem
Existing sample preparation containers for sterility testing face issues with false negative results due to retention of substances like antibiotics and contamination risks during sampling, especially with repeated access through the sampling port.
Innovation Solution
A sample preparation container design featuring a septum closed by a barrier wall, which is self-sealing and piercable, minimizes contact between the septum and the sample, reducing the risk of contamination and false results, and includes a preformed piercing location for controlled access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sampling port with removable sealing cap is provided for access to the container interior, then sampling operation can be performed, but contamination risk increases and false negative results may occur due to substance retention in death cavities
Solution Approach 1:
The sampling port is segmented into two functional parts: a removable sealing cap for access control and a fixed septum for sterile penetration. This segmentation allows the sealing cap to be removed only when needed while the septum remains in place, eliminating death cavities and preventing substance retention that could cause false negatives.
Solution Approach 2:
A septum is introduced as an intermediary element between the external sampling environment and the sterile container interior. The septum provides a controlled penetration point that maintains sterility during sampling operations, replacing the inadequate removable cap system and eliminating contamination risks associated with repeated cap removal and insertion.
2Adaptability or versatility
If repeated access to the container interior is allowed through the sampling port, then multiple sampling operations can be performed, but contamination risk increases with each access
Solution Approach 1:
The septum provides self-sealing functionality that automatically maintains sterility after each sampling penetration. The material properties of the septum allow it to seal around the sampling needle after penetration, eliminating the need for manual re-sealing operations and preventing contamination between repeated sampling events.
Solution Approach 2:
The septum acts as a permanent intermediary barrier that allows controlled repeated access without compromising sterility. Unlike removable caps that create death cavities and contamination risks with each removal, the septum maintains a continuous sterile barrier that is temporarily breached only during actual sampling operations.
3Reliability
If a removable sealing cap is used to seal the sampling port, then initial sterility can be maintained, but death cavities are formed that retain antibiotics and cause false negative results
Solution Approach 1:
The sealing function is segmented between the removable cap (for transport sterility) and the permanent septum (for operational sterility). This segmentation eliminates the death cavity problem by providing a flush-mounted penetration point that prevents substance retention, while still allowing initial sterility to be maintained through the removable cap during storage and transport.
Solution Approach 2:
The sampling port area is given special local quality with the septum integration, creating a flush-mounted structure that eliminates death cavities in the critical sampling region. The rest of the container maintains its standard design, but the localized improvement at the sampling port prevents antibiotic retention and false negative results.
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 design ensures sterile sampling with reduced risk of contamination and false negative results by preventing substance retention and material migration, while allowing controlled access to the sample space.
Implementation Method 1
a septum which is separated from the inside space by a barrier wall
Implementation Method 2
A sample preparation container design featuring a septum closed by a barrier wall, which is self-sealing and piercable
Implementation Method 3
the septum is separated from the inside space by a barrier wall
Implementation Method 4
a microporous membrane filter which strains microorganisms from the solution and concentrates them on the membrane filter
Implementation Method 5
a vent having a hydrophobic filter to prevent intake of bacteria
Data Source
AI summary
A sample preparation container, preferably for use in sterility testing, comprising a housing (1) having a housing wall (2) defining an inside space (3), a support on which a membrane filter is placed or is to be placed so as to get in contact with a sampling fluid to be introduced into the inside space (3), and at least one inlet opening (4) to the inside space (3) and at least one outlet opening from the inside space (3). A sampling port (5) is provided for allowing access from the outside to the inside space (3), wherein said sampling port (5) is closed by a septum (6) and the septum (6) is separated from the inside space (3) by a barrier wall (7) which is preferably piercable or breakable on application of an external force, preferably applied through a sampling instrument like a needle (8).