Ensure the quality of your pharmaceutical product with the help of optimum flow measurements in ultrapure water and Clean in Place applications

Maximum hygiene and precision are the prerequisites for producing safe medicines. The smallest deviations can enormously impair the effectiveness of the substances or even endanger human life. Pharmaceutical manufacturers therefore use numerous flowmeters to precisely control the flow and temperature of fluids. In a Clean in Place application, for example, the flowmeter measures the cleaning and rinsing liquids flowing in and out and controls the validated cleaning process. The quality and flow velocity of the ultrapure water used in the production process are also continuously monitored by the sensors. But how can you produce both reliably and efficiently?

Discover how the Bürkert FLOWave flowmeter improves production quality – and how you can save time and costs

Measure the flow exactly in the auxiliary cycles of pharmaceutical production

Clean in Place guarantees safe pharmaceutical production

Between individual batches, your products are cleaned aseptically in sterile conditions to avoid the risk of contamination. However, long cleaning periods and a high consumption of resources reduce your profit: You therefore want to optimise the cleaning processes from a hygiene and economic perspective.

Use a flowmeter to determine liquid consumption, minimum temperatures and cleaning concentration. Thereby ensuring that cleaning agents flow continuously and that no residues remain.

✓ Guaranteeing hygiene

Pharmaceutical substances are produced under the most hygienic conditions possible to guarantee the final product is safe and effective. Cleaning must be carried out reliably but also as quickly as possible.

✓ Ensuring safety

Processes must be controlled regularly and precisely to guarantee outstanding product quality. Accurate documentation of the cleaning processes is essential.

✓ Utilising the plant efficiently

High plant availability is important for optimum utilisation of production capacities. Low-maintenance sensors ensure production continues without additional downtime.

Ultrapure water of the highest quality

In the ultrapure water loop, you ensure a continuous flow of fluid: The continuous flow with a velocity of more than 0.9 m/s prevents the formation of biofilms. To control and monitor the ultrapure water supply, measure the total volume of hot and cold ultrapure water with a hygienic flowmeter. Easy installation and start-up are a great advantage in this case.

✓ Measuring hot and cold liquids precisely

The flowmeter must be able to measure both hot and cold ultrapure water precisely – regardless of its conductivity.

✓ Making installation as easy as possible

The flowmeter is often installed in difficult-to-access positions.

✓ Continuous checks

The total flow volume must be recorded and documented precisely in the process loop.

Did you know that many conventional measuring methods are not suitable for your production process?

Measuring the flow hygienically and ultra precisely

The Bürkert FLOWave flowmeter is ideal for pharmaceutical production. Using innovative SAW technology, it measures the volume flow without any sensors in the measurement tube – regardless of the conductivity of the media. Due to its smooth surface, FLOWave works efficiently and extremely hygienically: Sterile cleaning, no deposits, no tapering of the measurement point, no pressure drop. This ensures your plant always works efficiently and the reliability of your active pharmaceutical ingredients is guaranteed.

Simply one tube

FLOWave operates without sensor elements in the measurement tube: While passing through, your media only come into contact with a stainless steel tube. Thanks to its low weight of just 3.4 kg and compact dimensions, one person can install the flowmeter easily and quickly – at any installation position.

SAW technology: Innovative measurements for the pharmaceutical sector

FLOWave's SAW technology is well proven in the hygiene sector of the healthcare and pharmaceutical industries: Our patented SAW technology uses surface acoustic waves (SAW) for the inline flow measurement of liquids. This means that there are no sensor elements in the measurement tube that come into contact with the medium: An added benefit for the highest hygiene requirements. With no dead space, the flowmeter is also easy to clean.  Discover more about SAW technology.

Clean in Place (CIP) – why cleaning does not equal cleanliness

Cleaning a processing plant on site without removing any components is referred to as a Clean in Place (CIP) procedure. Cleaning and rinsing liquids are fed through the plant in validated processes to clean all surfaces in contact with the product. You have to define the correct cleaning agent as well as pressures, temperatures and times. A flowmeter like FLOWave can efficiently document and monitor the Clean in Place process – to ensure the substances produced are safe and effective.

Sequence of a cleaning process in the pharmaceutical industry:

1. Pre-rinsing with cold tap water prevents the swelling of auxiliary materials
2. Washing process with cleaning agent and higher temperature
3. Post-rinsing with tap water to remove tensides
4. Post-rinsing with purified water saves one disinfection step and prevents limescale

Successful partnership in the cleaning system

L.B. Bohle Maschinen + Verfahren GmbH ensures the highest standards of hygiene in its pharmaceutical cleaning system with the innovative Bürkert FLOWave flowmeter.

Optimising Clean in Place in the manufacturing cycle

FLOWave documents the media flow at the outlet of the CIP system.

FLOWave measures the return flow in the return line of the Clean in Place application.

Ultrapure water – why clean water does not equal ultrapure water

In contrast to conventional water, ultrapure water (water for injection) contains only a minimum amount of foreign substances such as minerals. It is used for the production of medical substances – either to rinse pipelines or to add it to the actual product. You probably need ultrapure water for the production of medicines or injection fluids, for medical research or chemical analysis. Using a flowmeter such as FLOWave, you can monitor the flow of ultrapure water at all times, even if it is non-conductive.

What characterises ultrapure water?

The European Pharmacopoeia stipulates the following requirements:

• Conductivity ≤ 1.1 μS/cm at 20 °C
• Bacterial endotoxins < 0.25 IE/ml (corresponds to roughly 25 ng/l)
• Total organic carbon (TOC) ≤ 0.5 mg/l
• Nitrate ≤ 0.2 mg/l

Successful partnership for manufacturing infusion solutions

To achieve maximum product safety, only the most state-of-the-art flow measurement systems can be used. As part of a field test, FLOWave was thus installed in the supply line of a filling machine for infusion bags.

Optimising ultrapure water in the manufacturing cycle

FLOWave documents the flow rate in the supply line of the ultrapure water circular pipeline.

Positioned in the return flow of the ultrapure water circular pipeline, FLOWave measures the consumption of ultrapure water.

Installation directly at the plant enables precise dosing and allocation of the flows.

FLOWave can be used flexibly

You can integrate FLOWave variably into your cycles: The flowmeter measures reliably and precisely at various positions.

Your added values in pharmaceutical production

Ultrapure water generation

Ultrapure water tank

1. FLOWave in the supply and return line of the WFI loop

FLOWave
Discover more about FLOWave

2. FLOWave in the sampling line

3. FLOWave in a partial cycle with Robolux

Robolux
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Sampling point

Example calculation: Cost savings through simple and precise handling

Put your trust in an innovative Bürkert technology that offers you numerous advantages while helping to save purchasing and operating costs as well as time. We have calculated it for the following scenario: You want to measure the flow and thus install two flowmeters at a height of three meters.

1. Simple installation in the pipeline and start-up

70 kg is the weight of a conventional Coriolis meter that requires an additional holder for attachment on the tube. 4 kg is the weight of a Bürkert FLOWave flowmeter that can be installed directly into the pipeline.

The Coriolis meter requires 60 minutes for start-up. FLOWave is installed in 30 minutes.

Coriolis meter: Costs for 2 holders 1,600 euros + service costs for start-up 170 euros = 1,770 euros total installation costs for two flowmeters

FLOWave: Costs for holders: 0 euros + service costs for start-up: 85 euros = 85 euros total installation costs for two flowmeters

2. Simple installation and disassembly for calibration

Result: The Bürkert FLOWave flowmeter can be installed quickly due to its lightweight and compact design and is a cost-effective solution. Due to its low weight, one person can install the easy-to-handle flowmeter quickly and easily. Additional tools are not required. All the key data for flow measurements is already pre-configured in FLOWave, thus ensuring the flowmeter is ready for operation immediately after installation. Zero point calibration is not required after installation.

FLOWave SAW flowmeter

Type 8098

• No obstacles inside the measuring tube, compact, lightweight and low energy consumption
• Conforms to hygienic requirements, CIP/SIP compatible
• Ideal for liquids with low or no conductivity
• Digital communication, parameterisation via Communicator, display
• Optional: ATEX/IECEx certification, II 3G/D