Sterile Sampling Apparatus with Multi-Path Flow Control
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Solution Overview
Problem
Current methods for sterile sampling in cell culture environments are cumbersome and time-consuming, particularly for mass cell culture production of bio-pharmaceuticals, as they require multiple lines and struggle to maintain sterility during sampling operations.
Innovation Solution
A sterile sampling apparatus with a network of flow paths, pumps, and opening/closing mechanisms that allows for easy and quick sample acquisition while maintaining sterility, using a one-way valve and buffer solution circulation to prevent contamination and facilitate efficient sampling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a pass box or isolator is used to carry samples from sterile to non-sterile space, then sterility is maintained, but sampling operation becomes troublesome and time-consuming
Solution Approach 1:
The patent introduces a sampling port as an intermediary device that connects the sterile culture container to the external sampling system. This port includes a needle that can penetrate the culture container seal, allowing sample extraction without breaking the sterile barrier. The sampling port acts as a mediator between the sterile internal environment and the non-sterile external environment, enabling easy sampling while maintaining sterility.
2Reliability
If a one-way valve is disposed to limit fluid flow direction, then sterility of isolator interior is maintained, but the system requires complex isolator infrastructure
Solution Approach 1:
The patent extracts the essential sterilization function from the complex isolator system and implements it locally at the sampling port. Instead of requiring a full isolator infrastructure with one-way valves and controlled environments, the invention uses a simple sampling port with a needle that can be sterilized independently. This extracts the core sterilization capability from the cumbersome isolator system, maintaining sterility without the complex infrastructure.
3Reliability
If multiple lines are prepared for sampling, then sterility can be maintained, but device complexity and preparation time increase
Solution Approach 1:
The sampling port is designed as a universal interface that can be used for multiple sampling operations. The single sampling port with needle can repeatedly penetrate and extract samples from different culture containers or the same container at different times. This multi-functional design eliminates the need for multiple dedicated sampling lines, reducing device complexity while maintaining sterility through repeated use of the same sterilizable component.
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
Enables easy and quick sample recovery at any time while maintaining the sterility of the culture environment, reducing the complexity and time required for sampling operations.
Implementation Method 1
a first pump that sends a fluid in the sixth flow path is disposed in the sixth flow path
Implementation Method 2
a second pump that sends a fluid in the seventh flow path is disposed in the seventh flow path
Implementation Method 3
a one-way valve that, in order to maintain a sterile space, limits a flow of a culture solution to a direction from the inside of the sterile space to the outside
Data Source
AI summary
A sterile sampling apparatus includes a first to seventh flow paths, a sampling section, a first and second pumps, and a first to sixth opening/closing mechanism. The sampling section is disposed in the seventh flow path. The first pump is disposed in the sixth flow path. The second pump is disposed in the seventh flow path. The second flow path includes a first opening/closing mechanism. The third flow path includes a second opening/closing mechanism. The fourth flow path includes a third opening/closing mechanism. The first flow path includes a fourth opening/closing mechanism. The sixth flow path includes a fifth opening/closing mechanism. The seventh flow path includes a sixth opening/closing mechanism. The rate of the second pump is higher than that of the first pump.