Ultrasound Transit Time Method for Non-Invasive Liquid Flow Measurement

Table of Contents

Introduction
The Flow Measurement System for Bioprocessing and Pharmaceutical Processes
System Accuracy
Customized Solutions and Flexibility
Process-Oriented Quality Assurance

Introduction

em-tec GmbH, a German-based company, has been developing and producing devices and components for the bioprocessing and medical industry for decades. The company, with many years of experiences, has become a strong partner in consulting, developing and manufacturing non-invasive flow measurement systems by means of the ultrasound transit time principle. It has adapted the well-known and medically certified bidirectional Clamp-On flow measurement system for liquids for special requirements of the good manufacturing practice (GMP) – oriented bioprocessing industry.

The Flow Measurement System for Bioprocessing and Pharmaceutical Processes

The BioProTT™ flow measurement system comprises of a a disinfectable Clamp-On transducer and a FlowTrack flowmeter with the measuring electronics. The Clamp-On transducer can be easily attached to the flexible tubing. The measurement can begin without splicing the tubing lines once the lid is closed. There is no contact between the measured medium and the sensor. The system design inherently ensures the sterility of the process and makes it perfect for processes with single-use applications and high hygienic requirements. This also makes sure that users are not exposed to toxic or similarly hazardous substances while integrating flow measurement into a bioreactor set-up.

A wide range of flexible tubing (typically also meeting special requirements of the food and pharmaceutical industries) can be supported with sensor sizes ranging from 1/32" (0.8 mm, internal diameter) to 1" (25.4 mm) and flows ranging from a few mL/min to 100 L/min. The sensors can be calibrated for seven different parameters — with alternative tubing materials, different media or temperatures, for example, depending on the accuracy requirements of customers. Media may contain alcohols, carbohydrates, salts, proteins, or cellular components, or it may be pure in the form of emulsion. The system is available with a number of flow meter options with standard interfaces (4-20 mA/RS-232) in order to enable an easy and optimal integration into the automated environment. The table version can also be employed as a stand-alone measuring device by including a user interface and display (for example, for laboratory setups).

System Accuracy

The high accuracy of the system has been prove in different customer applications. With Clamp-On technology, the non-invasive transit-time ultrasonic flow measurement can attain overall performance accuracy that is necessary for typical process control applications. Three different single-use system setups (gradient chromatography system, isocratic chromatography system and filtration system) were compared with the em-tec BioProTT™ flow measurement system as part of a poster presentation for an international event. Flow rates from 2 to 16 L/min were determined and assessed against a NIST-calibrated Coriolis meter. Results showed that flow rate measurement accuracies of better than ±2% of reading can be achieved over the complete linear range with proper unit setup and material calibration.

Customized Solutions and Flexibility

One major strength of em-tec GmbH is to support custom-made solutions and product developments with a very flexible and individual approach based on the following two features.

  • Customizable multichannel platform approach enables simultaneous monitoring of up to eight flow channels. Various interfaces and protocols for individual process control integration can be offered and adapted to specific project requirements.
  • Flow measurement components are developed for integration into customer-specific projects (OEM integration) with flexibility to adapt ot customer needs, for example, different housing materials for sensors (for instance, for stainless steel instrument) or with different branding options.

Process-Oriented Quality Assurance

The quality management system from em-tec GmbH is certified to ISO 13485, provides an accurate and complete technical documentation of a project and makes sure that all strict standards applied to medical device manufacturers are followed during a development process. In addition, em-tec GmbH has major experience in all classes of medical FDA and CE approvals.

em-tec GmbH.

This information has been sourced, reviewed and adapted from materials provided by em-tec GmbH.

For more information on this source, please visit em-tec GmbH.

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