Experts in WFI-loop systems: Bürkert

A Water for Injection (WFI) loop is a closed circuit that is used in the pharmaceutical industry for the distribution of highly purified water that meets the stringent regulatory requirements in accordance with the European, American, and Chinese pharmacopoeias (Ph. Eur., USP and ChP) and is obligatory for the production of pharmaceutical drugs. The WFI circuit ensures the availability of purified water of the highest quality.

WFI loop: The heart of a pharmaceutical production facility

A WFI loop is used not only for the distribution of water for injection (WFI), but also for controlling and monitoring numerous quality-dependent processes in the pharmaceutical industry. Purified Water (PW) and Highly Purified Water (HPW), also known as pharma water, or pharmaceutical water, must meet the highest purity standards, and is used in many critical applications. It is therefore essential to have a well-designed and monitored WFI loop to ensure product quality and compliance with regulatory requirements in the pharmaceutical industry.

What are the key considerations when it comes to WFI loops?

There are several key factors that must be considered to ensure the efficient and safe operation of a WFI loop:

Quality Control

Water quality must be continually monitored and documented to be compliant with regulatory requirements.

Flow control

The flow velocity must be measured to a high degree of precision, and must be controlled so as to ensure purity and availability.

Energy efficiency

An energy-efficient design of the loop is especially important, given the potential high operating costs.

Critical factors in WFI loops

Biofilm

One of the main issues in WFI loops is the formation of biofilms. These are formed by microorganisms that accumulate on the inner walls of the pipes and contaminate the water. The formation of biofilms can be prevented through careful monitoring of the flow velocity and water temperature.

Flow profile

The flow profile within a WFI loop must be turbulent to ensure an even distribution of water. A laminar flow profile or the existence of dead zones can lead to the accumulation of dirt particles and microorganisms.

Flow velocity

The flow velocity is another critical factor. This must be set to a velocity that prevents contamination and maintains maximum pump efficiency. However, if the flow is too fast, this can lead to increased wear of the pumps, as well as higher energy consumption or unnecessary pressure drops.

Our solution: FLOWave

The Type 8098 FLOWave flowmeter from Bürkert presents an innovative solution to the challenges faced in the context of WFI loops. FLOWave uses SAW (Surface Acoustic Waves) technology for contactless flow measurement. It has the following advantages:

High precision measurement

Thanks to the contactless method, the device can measure volume flow rate and temperature independently of conductivity.

Minimising the risk of contamination

Since there are no sensor elements in the measurement tube, there are no places where bacteria and contamination can accumulate.

Simple integration

The compact design simplifies the installation and maintenance of the device. In addition, all common communication protocols are available for connection to the control staff.

Reliability

FLOWave is less susceptible to faults and requires less calibration compared to conventional ultrasonic clamp-on sensors.

Removal of WFI water

In addition to FLOWave, Bürkert also offers all the components needed to implement a hygienic extraction system from a single source.

Holistic, intelligent solutions

The combination of FLOWave and unique Robolux double diaphragm technology creates entirely new possibilities for ultra-hygienic extraction of WFI from the loop:

“FLOWave is not just a flowmeter, but a completely unique instrument for quality assurance.”

Responsible project engineer of a leading manufacturer of infusions, clinical nutrition, pharmaceuticals and medical devices from Hesse, Germany

The future of contactless flow measurement: Type 8098 FLOWave

Tried and tested in the industry for years, innovative and reliable: optimise your flow measurement with the hygienic Type 8098 FLOWave flowmeter by Bürkert and take your industrial processes in pharmaceutical and biotechnology, and the food and beverage industry, to a new level!

Surface Acoustic Waves (SAW)

Bürkert customers use SAW technology for inline flow measurement of fluids with the innovative and tried-and-tested Type 8098 FLOWave flowmeter. In this glossary article, you’ll learn more about the basics of SAW technology, the measuring principle, the uses and benefits, and examples where this technology has been used successfully for years.

All bio pharmaceutical production under control

Like many sectors, the pharmaceutical industry is also undergoing digital change. Medicines have to be manufactured in ever faster time-to-market cycles, and pharmaceutical plants have to work more efficiently, more sustainably and more intelligently. Without jeopardising the highly sensitive process reliability.