Aseptic Sampling System with Sterile Barrier Membrane
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Solution Overview
Problem
Current aseptic sampling methods in bioprocessing and medical industries face challenges in maintaining sterility during repeated sampling, as infectious agents can be trapped between septa or transferred through non-sterile surfaces, potentially contaminating samples and reservoirs, and often require external sterilization methods.
Innovation Solution
An aseptic sampling system with a re-sealable liquid connection mechanism within a sterile enclosure protected by an air lock and outer protective surface, allowing for sterile connections and disconnections without exposing parts to non-sterile surfaces, using disposable components and avoiding external sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a needle pierces through two septa to create a fluid pathway, then sampling can be achieved, but infectious particles can be trapped between the septa and transferred to the needle
Solution Approach 1:
The patent introduces a sterile barrier membrane as an intermediary element between the non-sterile external environment and the sterile internal fluid pathway. The membrane acts as a mediator that allows controlled access while maintaining sterility, preventing direct contact between potential contaminants and the sampling system.
Solution Approach 2:
The patent employs a flexible sterile barrier membrane that can be pierced by the needle while maintaining its sealing function. This thin film structure allows the needle to pass through to establish fluid communication while the membrane's flexibility and sterility prevent contamination, solving the contradiction between operational access and contamination prevention.
2Reliability
If external sterilization methods are used to ensure sterility, then contamination can be reduced, but the process becomes more complex and time-consuming
Solution Approach 1:
The patent utilizes a disposable sterile barrier membrane that is pre-sterilized and single-use. This eliminates the need for complex external sterilization processes while ensuring sterility reliability. The membrane is discarded after one use, preventing cross-contamination and eliminating the need for re-sterilization procedures.
Solution Approach 2:
The sterile barrier membrane is pre-sterilized during manufacturing before reaching the user. This preliminary sterilization action ensures sterility is already established, eliminating the need for additional sterilization steps during the sampling process and reducing overall process complexity.
3Productivity
If repeated sampling is performed through the same needle and septa, then efficiency is improved, but the risk of contamination increases with each puncture
Solution Approach 1:
The sterile barrier membrane serves as a protective intermediary that maintains the sterility boundary during repeated sampling operations. Each time the needle pierces the membrane, the membrane's sterile surface prevents contamination from transferring to the needle, allowing multiple samplings while maintaining reliability.
Solution Approach 2:
The flexible sterile barrier membrane maintains its integrity and sterility through multiple punctures. Its material properties allow it to seal around the needle while preventing contamination, enabling repeated sampling operations without compromising sterility, thus maintaining both productivity and reliability.
Data Source
Figure 1a~1bii
Figure 2
Figure 3a
AI summary
An aseptic sampling system comprises a sampler assembly and an interface assembly. Each assembly comprises a housing, each housing defining a separate sterile enclosure for each of the assemblies. An air lock is arranged to provide, in use, the aseptic joining of the sterile enclosures within the sampler and interface assemblies, and a re-sealable liquid connection mechanism is positioned to operate within the air lock. The sampler assembly and interface assembly are arranged such that, when connected together, they form an outer protective surface comprising the housings of each of the sampler and interface assemblies, theouter protective surface providing a sterile internal enclosure and air lock and an air-tight barrier between the outer non-sterile atmosphere and the inner sterile atmosphere. The re-sealable liquid connection mechanism is contained within the sterile enclosure and contains at least one liquid connector from each of the sampler and interface assemblies and is configured such that, in use, at least one of the liquid connectors can move across the sterile enclosure and air lock to connect with the other connector in the liquid connection mechanism, without contacting any internal surfaces within the air lock, and is configured such that the liquid connectors, in use, can subsequently be re-sealed, disconnected and separated.