Aseptic Filter Vent Valve With Direct Integrity Test Port
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Solution Overview
Problem
Current filtration systems face challenges in maintaining sterility during integrity testing of filter assemblies, as conventional methods are prone to contamination and false failures due to complex flow paths and additional components introduced for testing, which can compromise the filter's integrity and the filtrate's sterility.
Innovation Solution
A filter capsule with an integrated aseptic valve and port allows for direct integrity testing of the internal filter element, minimizing the testing flow path and ensuring sterility through a design that includes a plastic integrity test assembly with a plunger and seals, specifically using polyethersulfone for enhanced strength and stability, and aseptic connections that can withstand multiple actuations without compromising sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional integrity testing methods are used with complex flow paths and additional components, then integrity testing can be performed, but contamination risk increases and sterility is compromised
Solution Approach 1:
The invention extracts the integrity testing function directly into the filter housing by integrating a test port and valve assembly, eliminating the need for external testing equipment and complex flow paths. This removes additional components that could introduce contamination, allowing integrity testing to be performed while maintaining sterility.
Solution Approach 2:
The integrity testing components (port, valve, seals) are merged with the filter housing to create an integrated assembly. This consolidation eliminates separate testing equipment and reduces the number of external connections, thereby minimizing contamination risk while maintaining reliable integrity testing capability.
2Reliability
If additional components and connections are added for integrity testing, then testing functionality is enabled, but device complexity increases
Solution Approach 1:
The integrity testing components are merged with the filter housing to create an integrated assembly. The test port, valve, and seals are incorporated directly into the housing structure, eliminating the need for separate external testing equipment and reducing overall device complexity.
Solution Approach 2:
The integrated port and valve assembly serves multiple functions: it enables integrity testing, maintains sterility during testing, and can be used for other process operations. This multi-functionality reduces the need for additional specialized components.
3Reliability
If integrity testing is performed downstream of the filter, then testing can be conducted, but contamination likelihood increases
Solution Approach 1:
The integrity testing function is extracted from downstream locations and integrated directly into the filter housing at the inlet side. This positioning allows testing to be performed before the filtrate exits the filter, eliminating exposure to downstream environments that could introduce contamination.
Solution Approach 2:
The integrated port and valve assembly acts as an intermediary that enables integrity testing while maintaining a sealed barrier between the test equipment and the sterile filtrate environment. This mediator allows testing functionality while preventing contamination pathways.
Data Source
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AI summary
The present disclosure relates to a filter capsule that supports direct integrity testing of an internal filter element. The filter capsule includes a filter housing having an inlet port, an outlet port, a passage running longitudinally between the inlet port and outlet port and holding a filter element, and an aseptic vent assembly. The filter housing also includes an integrity test assembly that can be used as a direct connection for integrity testing hardware, as opposed to upstream of the filter capsule. In one embodiment, the integrity test assembly comprises a body having a bore formed through its interior and a movable plunger within the bore. The plunger includes a handle to move the plunger between a closed position and an open position. Various seals between the plunger and the bore form a fluid tight seal between various portions of the plunger and the bore.