Key Takeaways
- Proline Promass U 500 is designed for cGMP compliance, targeting biopharmaceutical processes.
- The flowmeter features a unique, self-drainable disposable component available in four diameters, ensuring high accuracy.
- All components are produced under strict clean-room conditions and are certified for biocompatibility and safety.
Product Overview
The Proline Promass U 500 flowmeter from Endress+Hauser addresses the demands of current good manufacturing practices (cGMP) in biopharmaceutical processes. It is engineered for accuracy and precision in downstream applications, such as monoclonal antibodies, mRNA-based ingredients, and cell and gene therapies.
This flowmeter comprises a base unit with essential components, including the power supply, exciter, and sensors, available in two versions. The first is an installed model for original equipment manufacturers (OEMs) to integrate into their systems. The second is a flexible tabletop version that caters to laboratory settings, complete with necessary connections for seamless use. Both versions feature a common disposable component that can easily be replaced, facilitating maintenance and compliance.
Proline Promass U 500 accommodates flow rates from 0.12 to 75 l/min. A standout characteristic is its ability to maintain impressive accuracy—within 0.5% of mass flow—across a wide range of flow rates using a single nominal diameter. This level of precision is cited as unprecedented for single-use applications. The measuring tube is constructed from high-grade 316L stainless steel (AISI) or 1.4435 (EN), ensuring reliable and repeatable results superior to those from plastic alternatives.
Additionally, the flowmeter contains a plastic portion made from Makrolon RX1805, a medical-grade polycarbonate known for its performance in single-use settings. The materials used in the disposable components comply with international safety standards, including biocompatibility regulations defined by USP <87> and <88> and ISO 10993.
Manufacturing processes adhere to stringent clean-room standards, specifically ISO Class 7, to meet the hygiene requirements of biotechnological facilities. The components are delivered in double plastic bags and sterilized with gamma irradiation before use, ensuring high safety and quality levels.
The Proline Promass U 500 stands out in the biopharmaceutical industry, providing a robust solution for precise flow measurement in compliance with cGMP standards.
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