Single-Use Raman Bioreactor Interface for Sterile Real-Time Monitoring
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Solution Overview
Problem
Conventional monitoring strategies for mammalian cell cultures in single-use bioreactors lack real-time measurement capabilities and rely on manual sampling, increasing contamination risks, while existing Raman analyzers require sterilization and aseptic interfaces that compromise sterility and compatibility.
Innovation Solution
A single-use optical interface for bioreactor bags using Raman technology, featuring a disposable sleeve with a sapphire or quartz window and a clamp system to secure the probe, reducing ambient light interference and ensuring sterility without compromising the bioreactor's integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If reusable Raman analyzers are sterilized and integrated into bioreactor bags through aseptic interfaces, then real-time monitoring capability is achieved, but sterility is compromised and device complexity increases
Solution Approach 1:
The patent applies the disposable principle by making the optical interface (sleeve with window) a single-use component that is discarded after one use. This eliminates the need for sterilizing reusable sensors and maintaining aseptic interfaces, as the entire interface is replaced with a new sterile unit for each use. The disposable nature ensures sterility while enabling real-time monitoring.
Solution Approach 2:
The patent segments the monitoring system into separate components: a reusable Raman analyzer external to the bioreactor and a disposable optical interface (sleeve with window) that remains inside. This segmentation allows the analyzer to be sterilized separately or used externally, while the critical sterile barrier is the disposable sleeve that never leaves the sterile environment, thus maintaining sterility while enabling real-time monitoring.
2Measurement precision
If intrusive reusable sensors are inserted into the bioreactor, then real-time measurement is enabled, but contamination risk increases and sterility is compromised
Solution Approach 1:
The optical interface (sleeve with window) is designed as a disposable component that is discarded after single use. This eliminates the risk of cross-contamination between batches that would occur with reusable sensors, as each new sleeve is sterile and never contacts previous cultures. The disposable nature directly addresses the contamination risk while enabling real-time measurement.
Solution Approach 2:
The disposable sleeve with optical window acts as an intermediary between the sterile bioreactor environment and the external Raman analyzer. This intermediary allows optical signals to pass through while maintaining the sterile barrier, enabling real-time measurement without direct intrusion of non-sterile sensor components into the culture medium.
3Ease of operation
If ambient light is present during Raman measurement, then the measurement process is simpler, but the Raman signal quality deteriorates
Solution Approach 1:
The patent extracts or removes the harmful ambient light from the measurement path by using a sleeve design that blocks external light while allowing the Raman probe to function. The sleeve acts as a light-tight enclosure that isolates the measurement volume from ambient light, improving signal quality without complicating the overall measurement process.
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 real-time monitoring of bioreactor parameters with reduced contamination risk and improved sterility, maintaining the bioreactor's integrity by eliminating the need for intrusive reusable sensors.
Implementation Method 1
the optical interface includes a single-use cap to reduce the ambient light intensity which can be detrimental to a Raman signal
Data Source
AI summary
An optical interface with a housing such as a bioreactor bag, and a bioreactor bag having an optical interface. In some embodiments, the optical principle of Raman technology is used to provide several embedded single-use optical interfaces in a housing, with associated Raman probe modifications if necessary. In some embodiments, the optical interface includes a single-use cap to reduce the ambient light intensity which can be detrimental to a Raman signal. The device in accordance with embodiments disclosed herein allows for the avoidance of sterility breaks that typically may occur due to the insertion into the housing of an intrusive reusable sensor through an aseptic connection.