Semi-Automated Aseptic Sampling System with Sterile Barrier
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Solution Overview
Problem
Conventional aseptic sampling techniques for cell cultures are elaborate, expensive, and time-consuming, often compromising sterility and limiting the frequency and accuracy of sampling, which is crucial for monitoring and optimizing cell culture processes.
Innovation Solution
A semi-automated sampling assembly and system that includes a sampling conduit, recovery conduit, sampling kits, and a pumping device, allowing for aseptic sampling with reduced risk of contamination and carryover of residual samples, enabling frequent and accurate sampling without the need for repeated attachment of sampling kits to the sample source.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sampling techniques are used to withdraw samples from the culture vessel, then sampling can be performed, but the risk of contamination increases and sterility is compromised
Solution Approach 1:
The sampling system is divided into sterile and non-sterile zones using a sterile barrier (luer lock connector with membrane filter). The sterile side remains connected to the culture vessel while the non-sterile side interfaces with sampling equipment, allowing repeated sampling without breaching sterility.
Solution Approach 2:
A sterile barrier (membrane filter in the luer lock connector) acts as an intermediary between the sterile culture vessel and the non-sterile sampling equipment. This intermediary allows fluid passage while blocking contaminants, enabling easy sampling operations without compromising sterility.
2Productivity
If sampling is performed frequently to monitor cell culture process, then process optimization is improved, but the risk of contamination and carryover increases
Solution Approach 1:
A purge volume is established in the sampling line before each sample collection. This preliminary action flushes out residual samples from previous collections, preventing carryover and ensuring sample purity even with frequent sampling operations.
Solution Approach 2:
The sterile connection remains continuously intact between the culture vessel and sampling system. The system maintains continuous sterility protection while enabling repeated sampling actions, allowing high sampling frequency without compromising sample purity or introducing contaminants.
3Adaptability or versatility
If multiple tubes are attached to ports for different sampling instances, then sampling can be performed at different instances, but device complexity and contamination risk increase
Solution Approach 1:
A single sterile port with a luer lock connector serves multiple sampling instances. The universal sterile barrier interface allows different sampling equipment to connect repeatedly without compromising sterility, eliminating the need for multiple specialized tubes while maintaining sampling flexibility.
4Productivity
If conventional sampling methods are used, then samples can be collected, but time is consumed and cost increases
Solution Approach 1:
The sterile barrier and purge volume are established beforehand in the sampling line. This preliminary setup eliminates the need for time-consuming sterilization and purging steps during each sampling operation, significantly reducing sampling time and increasing efficiency.
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 facilitates efficient, aseptic, and cost-effective sampling by minimizing contamination risks and residual sample carryover, enabling more frequent monitoring and optimization of cell culture processes while maintaining sterility.
Implementation Method 1
circulating at least a portion of the biological inoculum using the pumping device
Implementation Method 2
aseptic sampling with reduced risk of contamination
Data Source
AI summary
A semi-automated sampling assembly configured for aseptic sampling at one or more instances from a sample source having a biological inoculum is provided. The semi-automated sampling assembly includes a sampling conduit, a recovery conduit, one or more sampling kits, and a pumping device. The sampling conduit includes a first port and a second port, where the first port of the sampling conduit is configured to be operatively coupled to the sample source. Further, the recovery conduit includes a first port and a second port, where the first port of the recovery conduit is configured to be operatively coupled to the sample source. Also, the second port of the recovery conduit is operatively coupled to at least a portion of the sampling conduit. Moreover, the one or more sampling kits are operatively coupled to the sampling conduit, and the pumping device is operatively coupled to the sampling conduit.