Fully cGMP-compliant, single-use Coriolis flowmeter for biotechnology
Proline Promass U 500 for flow measurement in single-use applications is reported to be the first fully cGMP-compliant single-use Coriolis flowmeter for biotechnology. It 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 that OEM manufacturers can integrate into their platforms.
For flexible laboratory applications, a tabletop version is available in its housing with corresponding connections to the local working environment. The two versions have the same function. The disposable component is inserted into the base unit. To cover a range of applications, the disposable component is offered in four nominal diameters: DN 4 (⅛ in.), DN 6 (¼ in.), DN 15 (½ in.) and DN 25 (1 in.) This section 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.
One of Proline Promass U 500’s unique features is its ability to cover a range of flowrates with one nominal diameter without compromising measuring accuracy. This is 0.5% of mass flow, a value not previously achieved by single-use applications.
To enable Coriolis technology to provide its maximum accuracy with simultaneous measurement of flow, temperature and density Proline Promass U 500 uses 316L (AISI) or 1.4435 (EN) stainless-steel for its measuring tube. Meanwhile, the Makrolon RX1805 polycarbonate used for the plastic portion that also contacts production media is a medical-grade plastic that has long been trusted in single-use applications.
To prove its suitability for use in biotechnology, Proline Promass U 500 holds a compliance certificate that shows its disposable components and materials meet relevant international regulations, namely biocompatibility by USP <87> and <88> and ISO 10993. These disposable parts are also assembled under ISO Class 7 clean-room conditions required for many biotechnological facilities. These components are also delivered in double plastic bags, and prepared using gamma-irradiation sterilization before use.
In addition, Proline Promass U 500’s disposable components can be inserted and locked in the base unit with one hand. These tasks can also be easily performed while wearing protective clothing in clean-room conditions. Upon insertion, an integrated camera reads the item’s QR code, which is 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.