Sterile Fluid Collection via Alternating Valve Control
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Solution Overview
Problem
In biopharmaceutical and vaccine production, there is a need for systems and methods that allow for the collection of representative fluid samples without breaching the sterility of bulk sterile containers, as removing samples from these containers can compromise their sterility.
Innovation Solution
A collection system comprising multiple container sets and a control unit that alternately connects to an upstream system, using valves with multiple outlets to fluidically couple with containers, allowing for the collection of fluids like proteins, peptides, and vaccines without compromising sterility, by alternating the connection between different containers to ensure representative sampling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a sample is removed from a bulk sterile container for analytical testing, then representative sampling is achieved, but the sterility of the bulk container is compromised
Solution Approach 1:
The system divides the sampling function into separate segments: a sampling port connected to the bulk sterile container, a valve mechanism for controlling fluid flow, and a separate collection container. This allows sampling to occur through the sampling port without direct access to the bulk container, maintaining sterility while enabling representative sampling through controlled fluid extraction.
Solution Approach 2:
The valve mechanism acts as an intermediary between the bulk sterile container and the collection container. It controls the fluid flow path, allowing samples to be transferred without direct connection between the bulk container and external environment, thereby maintaining sterility while enabling sampling.
2Reliability
If multiple containers are used to alternately collect samples, then continuous sampling without sterility breach is achieved, but device complexity increases
Solution Approach 1:
The system combines multiple containers into a container set that works together with a single valve mechanism. The valve selectively connects different containers to the sampling port, merging the sampling function across multiple containers while maintaining a unified control system, thereby managing complexity through integration rather than separate control mechanisms.
Solution Approach 2:
The system employs periodic action by alternately switching between different containers in the container set. The valve sequentially connects Container 1, then Container 2, then Container 3, and so on, allowing continuous sampling operations while maintaining sterility through controlled, periodic switching between containers.
Data Source
AI summary
Disclosed are systems and methods for alternately collecting a fluid in a plurality of containers without breaching its sterility. The system generally includes one or more collection modules, each having a valve and one or more container sets fluidically connected to the valve. Each container set includes first and second containers. The system also includes a control unit to control operation of the valve of each collection module to facilitate alternate collection of the fluid by the first and second containers of a container set. This may ensure that the fluid collected in one container is a true representative sample of the fluid collected in the container without compromising its sterile integrity.