Single-Use Chromatography

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Introduction Customer Background

X Bio is a premier manufacturer of downstream processing equipment for the biopharmaceutical industry, and the products include process chromatography, dilution chromatography, ultrafiltration, TFF, depth filtration, virus removal, etc.

Challenge

The single-use chromatography system is a specialized disposable chromatography system for process scale-up and production.

It utilizes disposable flow paths and pre-packed columns for flexible and rapid bioprocessing. The main feature of this system is that the entire flow path can be easily replaced without the need for system cleaning (including validation), thus simplifying the operational process and improving work efficiency, making it an indispensable tool in modern bioprocessing.

As X Bio aimed to design its single-use chromatography products, it faced the challenge of accurately measuring fluid flow rates during the purification. Conventional flow measurement techniques often require direct contact with the bio-media, posing contamination risks and complicating the single-use design.

Additionally, precise flow rates measurement is critical, as variations could lead to inefficient column performance and lower yields, ultimately affecting product quality and regulatory compliance.

Solution

To address these challenges, X Bio integrated the CG series non-invasive ultrasonic flow sensor into the single-use chromatography system.

CG series ultrasonic flow sensor is designed to measure liquid flow rates without direct contact with the fluid, ensuring the single-use chromatography system remains contamination-free.

The ultrasonic flow sensor can be easily clamped onto the existing flexible plastic tubing of the chromatography system.

It can provide real-time flow measurement with high accuracy and efficiency, allowing system operators to monitor the critical parameters in the purification process.

By integrating with the chromatography control system, the flow sensor supported dynamic adjustments to process conditions based on the real-time data it provided.

Customer Value

The implementation of the CG series non-invasive ultrasonic flow sensor yielded several significant benefits for X Bio and its customers:

±3% Accuracy: The ultrasonic flow sensor enabled accurate and reliable flow measurements, which improved the performance of the chromatography system and minimized variability in the purification process.
No Contamination: the clamp-on sensor ensured that the measured media remained sterile, eliminating the risk of cross-contamination between batches.
Operational Efficiency: Real-time monitoring allowed operators to optimize flow rates dynamically, leading to improved throughput and higher yields, directly impacting overall productivity.
Reproducible result: In the biopharmaceuticals industry, flow rate measurement reproducibility plays a crucial role in quality control and assurance. For example, in drug development, reproducible results are essential for ensuring the safety and efficacy of medications.
No blockage, no steering, no blind spots; low fluid pressure loss. Non-contact measurement prevents any tubing blockage, ensuring smooth system operation and lower maintenance cost.
Support bidirectional measurement, fluid volume calculation, and bubble detection function.
XY-TEK provides customized calibration for customer-specified tubing materials, sizes, temperatures, and liquid types.

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By enhancing accuracy, preventing contamination, and improving operational efficiencies, XY-TEK’s ultrasonic flow sensor has proven to be a vital component to X bio’s single-use Chromatography System, benefiting their customers and contributing to the advancement of bioprocessing technology.