The development of new active ingredients is becoming increasingly complex. In the biopharmaceutical industry, flexible and dynamic processes for cell- and gene-based therapies, mRNA technologies and personalized treatments are therefore becoming more important. Agile production methods and smart technologies help biomanufacturers react more efficiently to market dynamics and bring innovations faster to the market. That is why single-use systems are being used more frequently in such demanding processes.
Single-use instrumentation is not a new trend in biotech, but with Proline Promass U 500, completely new possibilities arise. The first cGMP-compliant single-use Coriolis flowmeter enables the usage of economical and safe single-use systems in both batch and continuous production processes. Promass U 500 delivers first-class measured values, time-saving commissioning, simple operation and flexible use.
The major advantages of single-use compared to multi-use systems include not only greater flexibility and minimized risk of cross-contamination, but also shorter production times and significantly lower investment costs. In addition, complex cleaning and sterilizing processes (CIP and SIP) are no longer necessary, which reduces cleaning and energy costs.
From an operator point of view, an “ideal” single-use instrument should include the following features:
Seamless integration into an existing digital infrastructure
Pre-calibrated and ready to use without manual intervention
Compatible with nonintrusive calibration and integrity testing required by customers and regulatory authorities
Measurement quality equal to or better than traditional, multi-use sensing technology
In recent years, the biopharmaceutical industry has increasingly relied on flexible manufacturing to meet variable production requirements. This shift has driven the development and adoption of single-use technology, allowing operations to quickly scale from clinical trials and small batches to conventional large batch sizes up to 2'000 liters. In addition, single-use technology has evolved significantly, and new systems are improving productivity and adaptability, with designs optimized for scale-out flexible facilities.
The costs for repeated purchases of single-use components are generally more than offset by the avoidance of cleaning, sterilization, validation, related time lost, and the reduced flexibility that comes with multi-use facilities. Single-use systems are therefore now an integral part of modern biopharmaceutical manufacturing, especially in the development and manufacture of products based on animal cell cultures. This shift opens new opportunities in advanced therapies such as cell and gene therapies, personalized medicine and monoclonal antibodies.
Coriolis measuring technology is ideal for biopharmaceutical single-use applications requiring precise and reliable mass flow measurement as well as compliance with stringent industry standards. Compared to other technologies, the Coriolis measuring principle offers several advantages that make the technology a superior choice for single-use biopharma applications in the life sciences industry:
Provides significantly higher accuracy and the ability to measure multiple variables (flow, temperature, and density) across various conditions
Improves process control and monitoring thanks to multivariable capabilities
Allows sterilization of the measuring tubes (e.g., by gamma, X-ray, or autoclaving), eliminating any risk of cross-contamination
Offers economic advantages due to unmatched accuracy in batching and dosing applications, thereby paying for itself after a short time
Requires no straight inlet or outlet runs and remains unaffected by changes in the fluid properties (conductivity, density or temperature)
Proline Promass U 500
For high-precision, reliable flow measurement in biopharmaceutical single-use applications, Proline Promass U 500 is the optimal solution:
Flexible installation options, including a built-in version for front panel mounting on skids and a tabletop version with housing for laboratories
Gamma-sterilizable measuring tube made of 316L (1.4435) stainless steel
Disposable components in four nominal diameters (DN 04 / 1/8"; DN 06 / 1/4"; DN 15 / 1/2"; DN 25 / 1") fit into one base unit, covering flow rates from 0.12 to 135 kg/min for maximum flexibility and standardization
Single-use technology with a surprising sustainability balance
Water and energy consumption are significantly reduced due to the elimination of cleaning and sterilization processes compared to multi-use technology.
Q&A: Enhancing biopharmaceutical manufacturing efficiency with single-use instrumentation
In this interview, Bethany Silva, Life Sciences Industry Marketing Manager at Endress+Hauser USA, discusses the growing role of single-use technologies and how Endress+Hauser’s innovations in flow measurement are supporting modern biopharmaceutical production.
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Proline Promass U 500 Coriolis flowmeter
First single-use flowmeter for biotech applications with premium performance, cGMP compliance, and up to 4 I/Os
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Proline Promass U 500: The first single-use flowmeter with premium performance and cGMP compliance for the biopharmaceutical industry