Sterile Probe Sampling for Single-Use Vessel
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Solution Overview
Problem
Existing systems for transferring chemical, pharmaceutical, and biological materials into or out of containers, such as bioreactors, face challenges in maintaining sterility and preventing deformation of transfer interfaces, which can lead to compromised connections and loss of sterility.
Innovation Solution
A disposable container system with a transfer interface that includes extensible transfer elements, biasing elements for retraction, and a locking mechanism to ensure sterile sampling and prevent deformation, maintaining a secure and sterile connection with the container.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a transfer interface is used to access the container, then sampling and transfer operations can be performed, but the transfer interface may deform leading to compromised connections and loss of sterility
Solution Approach 1:
The transfer interface is divided into multiple independent transfer elements (needles, cannulas, or probes) that can be individually extended and retracted. Each element operates independently within sealed boreholes, allowing sampling operations without compromising the overall connection integrity of the container port.
Solution Approach 2:
The transfer elements are nested within sealed boreholes of the transfer interface body. Each transfer element can be extended from its borehole for sampling operations and then retracted back into the sealed borehole, maintaining sterility and connection integrity when not in use.
2Quantity of substance
If multiple sampling operations are performed, then sufficient samples can be obtained, but maintaining sterility becomes increasingly difficult
Solution Approach 1:
The transfer interface is designed as a disposable component that is sterilized before use and then discarded after a single use or single campaign of sampling operations. This eliminates the need to maintain sterility across multiple uses and prevents cross-contamination between batches.
Solution Approach 2:
The transfer interface and all its transfer elements are pre-sterilized before use through autoclaving, gamma irradiation, or other sterilization methods. This preliminary sterilization ensures sterility is established before the container is accessed, eliminating the need to maintain sterility during repeated operations.
3Productivity
If transfer elements are extended for sampling, then material can be extracted, but the transfer interface may become deformed
Solution Approach 1:
The transfer elements are designed to be dynamically extendable and retractable within sealed boreholes. Each element can be extended only when needed for sampling and then retracted to its original position, allowing the transfer interface to return to its undeformed state after each sampling operation.
Solution Approach 2:
The transfer interface is designed with sufficient structural rigidity and appropriate wall thickness in the borehole regions to prevent deformation during transfer element extension. The structure is pre-engineered to withstand the mechanical stresses of sampling operations without compromising connection integrity.
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 system effectively enables sterile sampling and transfer of materials while preventing deformation and maintaining sterility, ensuring the integrity of the contents and the equipment.
Implementation Method 1
Each of the transfer elements has a corresponding biasing element for retracting the transfer element
Data Source
AI summary
A system and method for transferring chemical, pharmaceutical, and/or biological material into or out of a container are provided. Further, a use of a transfer interface for accessing the interior of a disposable container is provided. The system comprises a disposable container having at least one port for accessing the interior of the container. The system further comprises a transfer interface connectable to the at least one port. The transfer interface comprises a plurality of extendable transfer elements for collecting samples from the disposable container in a sterile manner. The transfer elements may also be referred to as sampling elements, extractors, or probes. Each of the transfer elements has a corresponding biasing element for retracting the transfer element. The biasing element may be implemented as a spring or as another device capable of applying a biasing force.


