- December 17, 2024
- Endress+Hauser, Inc.
Dec. 10, 2024 - Single-use technologies have become a focal standard in biopharmaceutics. Compliance with cGMP criteria is also a matter of course and calls attention to the instrumentation of biotechnological single-use processes. The Proline Promass U 500 Coriolis flowmeter from Endress+Hauser is designed for these applications. Accuracy, precision and traceable calibration are at the top of the list of requirements, followed by simple handling and a straightforward user interface.
Just as research and development rely on smaller, more dynamic and flexible processes, the production of biopharmaceutical products is also becoming more agile, diversified and, as a result, typically smaller in scale. Single-use bioreactors have long been the standard in upstream applications and are perhaps the most significant prospects for downstream processes in growth markets such as monoclonal antibodies, mRNA-based active ingredients and cell and gene therapies.
The Proline Promass U 500 from Endress+Hauser is a Coriolis flowmeter that has the potential to progress the technological maturity of single-use applications on the side of measuring technology. However, transferring the performance capability of Coriolis technology, which is already familiar in other industrial areas, to this new application is no small feat.
When the overall requirements for automation, reproducibility, conformity with international regulations, traceability, calibration or cGMP compliance are high, the technologies available on the instrumentation market to date have often fallen short of the standards achieved by established multi-use measuring devices. As part of a joint development with OEM customers and end users, Endress+Hauser has fully integrated these criteria into the design of the Proline Promass U 500. The catalog of requirements and recommendations collected as part of the BioForum Operations Group were also considered.
High-level measuring performance thanks to Coriolis technology and material selection
The Proline Promass U 500 consists of a base unit containing the components for the power supply, exciter, sensors and other electronics. This base unit is available in two versions: The first is an installed version, which OEM manufacturers can integrate into their platforms. For flexible laboratory applications, a tabletop version is also available in its housing with the corresponding connections to the local working environment. The two versions do not differ in terms of function. The disposable component is inserted into the base unit.
To cover an extensive range of applications, the disposable component is offered in four different nominal diameters: DN 4 (⅛"), DN 6 (¼"), DN 15 (½") and DN 25 (1"). It is also designed to be self-drainable, which makes handling easier for disposal. The technical data specifies flow rates of 0.12 to 75 l/min. A unique feature of the Proline Promass U 500 is its ability to cover a wide range of flowrates with one nominal diameter without compromising on measuring accuracy. This is 0.5% of mass flow, a value never reached in single-use applications. With the high price of many biopharmaceuticals, measurement inaccuracies can quickly lead to economic disadvantages. Along with the requirements for the process technology, this calls for the most precise measuring technology possible.
Endress+Hauser manufactures the disposable component in a more complex way. While all-plastic solutions may be the clear choice for ease of manufacturing and waste prevention, there are more efficient solutions for this measuring technology. The vibration behavior of plastics is not optimal for Coriolis technology. The stainless-steel measuring tube enables repeatable, accurate and precise results, which are difficult to achieve with plastic tubes.
The development team decided on 316L (AISI) or 1.4435 (EN) stainless steel for the measuring tube to enable the Coriolis technology to exhibit its full strengths: maximum accuracy with the simultaneous measurement of flow, temperature and density. This is also a significant factor that sets the technology apart from alternative processes, such as gravimetric measurements.
The polycarbonate used for the plastic portion that also contacts media, specifically Makrolon RX1805, is a medical-grade plastic that has long been trusted in single-use applications. The measuring performance of the Proline Promass U 500 puts it in the high-end range due to the proven sensor technology from the existing Coriolis product family from Endress+Hauser and the material selection.
Endress+Hauser proves its suitability for use in biotechnology with a "Certificate of Compliance," which certifies compliance of the disposable components and materials used with the relevant international regulations. In this case, this is biocompatibility by USP <87> and <88> and ISO 10993. The disposable components are assembled under clean-room conditions, specifically ISO Class 7, corresponding to the production environment of many biotechnological facilities. They are delivered in double plastic bags. Before use, the disposable component is readied using gamma irradiation sterilization.
Pre-calibrated disposable component is detected automatically
So far, single-use systems have often been characterized by low automation. However, many manual steps are time-consuming and prone to error, making user instruction, monitoring and documentation of the system and operation challenging. For the end user, however, the monitoring and tracing of components is a critical part of their quality assurance process. As part of these requirements, significant effort must also be spent on documentation, certification and the calibration of the disposable component.
The Proline Promass U 500 disposable components can be inserted and locked in the base unit with one hand. The operations can also be done easily under clean-room conditions, i.e., while wearing protective clothing. Upon insertion, an integrated camera reads the QR code, which was attached during factory calibration, and the device starts an automatic verification process. Using Heartbeat Technology from Endress+Hauser, the base unit automatically verifies the validity of the factory calibration, eliminating complex and time-consuming calibration on site. This is a guided process for traceable verification of measuring devices by ISO 9001 with automatically generated verification reports.
Heartbeat Technology documents the device's functionality and delivers continuous process and diagnostics for condition monitoring and collects information for process optimization. Standardized diagnostic messages at an early stage with recommendations for possible corrective measures to increase operational and process reliability. The functions of Heartbeat Technology can be fully utilized in a digital production environment, mainly: The device communicates via secure, rapid data transfer over 2-wire Ethernet in Profinet networks for connection to PLC systems. Furthermore, cloud-based data handling enables access regardless of location.
The Proline Promass U 500 offers full cGMP compliance, particularly during calibration, and high-level measuring performance for flow, temperature and density. At the same time, the flowmeter reduces the end user's handling and documentation effort.
Heartbeat Technology plays a crucial role in diagnostics, verification and monitoring. This makes the device equally beneficial for OEM manufacturers of single-use biotechnology platforms and lab users who also want to leverage the potential of innovative, cost-efficient single-use systems in downstream processes. In addition, the Proline Promass U 500 from Endress+Hauser is a forward-looking component of the digital transformation of biotechnology.
Go to Endress+Hauser, Inc. website