Aseptic Tamper-Evident Sampling Container With Septum
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Solution Overview
Problem
Conventional flip-top vials for biological sample storage are prone to contamination during filling due to open handling methods, compromising the integrity of the samples and lacking tamper-evident features, which can lead to false positive test results.
Innovation Solution
Aseptic, tamper-evident sampling containers with sealed lids and integrated fluid transport adapters that allow aseptic fluid transfer without opening the container, using septums and lumens to create a fluid passageway and vent, enabling sterile filling while maintaining the container's sealed and tamper-evident state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional flip-top vials are opened for filling, then fluid samples can be transferred into the container, but the sample is exposed to ambient conditions and contamination risk increases
Solution Approach 1:
The patent introduces a needle as an intermediary tool that pierces the septum to create a controlled fluid pathway. This mediator enables fluid transfer without opening the container, thus maintaining the sterile environment while allowing sample filling. The needle acts as a temporary conduit that bridges the external fluid source and the sealed container interior.
Solution Approach 2:
The invention extracts the filling function from the container opening process. Instead of opening the flip-top lid to fill the container, the design allows the container to remain sealed while a needle pierces the septum for fluid transfer. This separation of filling operation from lid opening eliminates exposure to ambient contamination.
2Ease of operation
If conventional flip-top vials are used, then they can be opened and closed for filling, but they lack tamper-evident features compromising sample integrity verification
Solution Approach 1:
The tamper-evident mechanism is pre-configured in the sealed container design before filling occurs. The interlocking features between lid and container body are established during manufacturing, ensuring that any attempt to open or tamper with the container will visibly compromise the seal. This preliminary setup of tamper evidence does not interfere with the filling operation through the septum.
Solution Approach 2:
The container is segmented into distinct functional components: the sealed container body with integrated septum, the flip-top lid with tamper-evident features, and the needle for fluid transfer. This segmentation allows the tamper-evident mechanism to function independently while the needle provides the filling capability through the septum without compromising either function.
3Reliability
If a sealed container with integrated septum is used, then tamper-evident features are maintained, but the container requires specialized design with fluid transport adapter
Solution Approach 1:
The invention merges multiple functions into the container design: the septum is integrated directly into the container body, the flip-top lid provides both closure and tamper-evident features, and the needle serves as both the filling tool and the fluid transport pathway. This consolidation of functions reduces the need for separate components like external caps or complex adapter systems.
Solution Approach 2:
The flip-top lid serves multiple functions: it provides the closure seal, incorporates the tamper-evident mechanism, and allows access to the septum for fluid transfer. The septum itself is multi-functional, serving as both a barrier to maintain sterility and a pathway for needle insertion. This multi-functionality reduces overall device complexity despite the specialized design requirements.
Data Source
Figure 1A~1B
Figure 2~3B
Figure 4
AI summary
A closed and tamper-evident sealed container, including a fluid transport adapter. The adapter provides for sterile fluid communication between a fluid source outside the container and the container interior when adapter is open. The adapter is adjustable to a closed position wherein the fluid communication ceases. An alternative to the adapter utilizes a sampling attachment that fits into tight engagement with the lid which comprises at least one septum. Coupling the sampling attachment to the lid either causes sharps in the attachment to penetrate the at least one septum or to displace the edges of the septum inward to form a fluid communication with the container interior while the lid remains sealed closed. Other variations include a rotatable sampling attachment, a container with a displaceable bottom wall to act as a syringe and a large volume (e.g., 1500mL) sealed ampoule which also uses a sampling attachment.