Membrane-based pure media systems

Syntegon offers a modular, turn-key solution for the “cold” membrane-based generation of pharmaceutical-grade pure water (PW), high purity water (HPW), and water for injection (WFI). Employing a full range of technologies including multi-layer filtration and ultrafiltration as well as physical-chemical processes including reverse osmosis and electrodeionization, our systems are configured to precisely address your individual requirements. Storage can be either hot or cold. Our approach substantially reduces the associated footprint, energy consumption, investment costs, qualification expenses, and ongoing maintenance costs when compared to traditional distillation-based systems.

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Key benefits

Reliability

The robust membrane-based technology is highly reliable. You can count on both the quality of the water and the stability of its supply.

Serviceability

The modular design is highly hygienic and accessible. Routine maintenance is quick and easy, minimizing downtime.

Sustainability

The compact skidded system is highly energy-efficient. The approach substantially reduces both operating costs and the carbon footprint.

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Configuration flexibility

Syntegon’s membrane-based pure media systems are robust, proven modular solutions that can be easily and quickly configured to meet your specific requirements. All modules are pre-tested and readily available. With a nominal production range of 200 to 20,000 liters per hour, the skidded systems are suitable for clinical and commercial manufacturing facilities alike.

Energy efficiency

Syntegon uses the highly energy-efficient “cold” membrane process of reverse osmosis, along with electrodeionization and ultrafiltration, in a modular, full-featured design. Storage can still be either hot or cold. This approach substantially reduces the initial capital investment, required footprint, energy consumption, as well as the ongoing qualification and maintenance costs when compared to traditional distillation-based systems.

Footprint and serviceability

Featuring a small footprint and height in all configurations for easy drop-in installation, the modular design is highly hygienic and accessible, making maintenance quick and easy. Measuring devices and sensors throughout ensure that the filter and water quality are monitored and maintained during the entire production process.

Water for injection (WFI) is an essential utility in pharmaceutical manufacturing that has traditionally been generated through the energy-intensive process of distillation. The recent revision of monograph 0169 of the European Pharmacopoeia, however – which has aligned the EP with the US and Japanese Pharmacopoeias in allowing suitable techniques other than distillation for the generation of WFI – has now made highly energy-efficient membrane-based systems a universally accepted alternative.

Benefits:

Processes for PW, HPW, and WFI quality
All “cold” processes with high energy efficiency
Modular design to meet customer-specific requirements
Skidded, compact system with drop-in installation
Excellent accessibility for easy maintenance

Our “cold” membrane-based systems employ a full range of unit operations including multi-layer filtration and ultrafiltration as well as physio-chemical processes including reverse osmosis and electrodeionization to precisely address our customers’ individual requirements. Our systems are capable of continuous production during partial sanitization with hot water and can also be sanitized chemically. Storage can be either hot or cold, based on your specific applications. Measuring devices and sensors throughout ensure that the unit operations and water quality are monitored and maintained during the entire production process.

Benefits:

Processes for PW, HPW, and WFI quality
All “cold” processes with high energy efficiency
Modular design to meet customer-specific requirements
Skidded, compact system with drop-in installation
Excellent accessibility for easy maintenance

A precise analysis of your requirements ensures that the right amount of water is available at all points of consumption without any loss of quality. Particular attention is paid to monitoring and hygiene during cold or hot storage. Pure water tanks with modular distribution skids are available for cold storage and distribution of PW or WFI. Ozone can be added to protect against microbial contamination. During production, a UV system in the supply system of the ring line ensures that the dissolved ozone is depleted. During hot storage, WFI is continuously recirculated. Cold taps are provided via sub-loops with integrated cooling modules.

Benefits:

Comprehensive storage and distribution systems for PW, HPW, and WFI
Well-designed solutions for cold and hot storage
Continuous monitoring of all quality-relevant attributes
Sanitization method flexibility according to the requirements
Easy expansion thanks to a modular design

Turning to hot storage to avoid treatment with ozone no longer means bigger, more expensive, and energy-hungry generation systems. Hot WFI storage and distribution is now a standard option for our membrane-based “cold” WFI generation systems. This innovative approach is enabling customers preferring or requiring hot WFI storage to realize significant savings in both CAPEX and OPEX. The smaller footprint makes it a convenient, affordable drop-in option for existing facility upgrades and new facilities alike. What’s more, the energy savings from reduced or altogether eliminated cold water and heating steam consumption make it a highly sustainable solution.

Benefits:

The advantages of hot storage plus those of “cold” generation
Modular design to meet customer-specific requirements
Skidded, compact system with drop-in installation
Excellent accessibility for easy maintenance

Use case scenarios

Raw/Potable water pre-treatment

Tailored modular pretreatment systems for both raw and potable water

Pure and high purity water

Membrane-based, energy-efficient GMP generation of PW and HPW with a small footprint and excellent accessibility

“Cold” water for injection

Membrane-based, highly energy-efficient GMP system for the “cold” generation of WFI with ultrafiltration for the final reduction of endotoxins

Storage and distribution

Comprehensive storage and distribution systems for PW and WFI with continuous monitoring of all quality-relevant attributes

Recirculation loops

Distribution loops with recirculation lines with point-of-use management and sanitization

Interested?

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Technical data of our membrane-based pure media systems

pretreatment up to

l/h

PW and HPW up to

l/h

WFI up to

l/h

storage and distribution up to

l/h

Technical data

	Pretreatment	PW and HPW	WFI	Storage and Distribution
Output* (l/h)	up to 20,000	200-20,000	300-13,000	up to 38,500
Options	raw water ultrafiltration activated carbon filter hot water sanitization multimedia filter chemical dosing	softening antiscalant dosing thermal sanitization chemical sanitization sanitization and softening during operation mode	hot WFI production softening antiscalant dosing thermal sanitization chemical sanitization sanitization and softening during operation mode	double pump station steam sterilization (SIP) UV lamp TOC measurement cold storage with sanitization 85C hot storage with sanitization 121C cold storage with ozone

Pretreatment

PW and HPW

WFI

Storage and

Distribution

Output*

(l/h)

up to 20,000

200-20,000

300-13,000

up to 38,500

Options

raw water ultrafiltration
activated carbon filter
hot water sanitization
multimedia filter
chemical dosing

softening
antiscalant dosing
thermal sanitization
chemical sanitization
sanitization and softening during operation mode

hot WFI production
softening
antiscalant dosing
thermal sanitization
chemical sanitization
sanitization and softening during operation mode

double pump station
steam sterilization (SIP)
UV lamp
TOC measurement
cold storage with sanitization 85C
hot storage with sanitization 121C
cold storage with ozone

Configure-to-order selection

We offer the right pretreatment, generation, and storage and distribution solutions for every water quality. Larger and intermediate sizes are also available upon request, as well as a wide range of other modular options that can be integrated into customer-specific systems.

*standard configure-to-order systems; custom solutions with higher output are also available

Service Agreements

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Digital Solutions

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Parts

Find out more about Parts here.

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Maintenance

Find out more about Maintenance here.

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Technical Support

Find out more about Technical Support here.

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Modernizations

Find out more about Modernizations here.

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Training

Find out more about our Training here.

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Expert Services

Find out more about our Expert Services here.

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We have the right technology and experience

The Syntegon subsidiary Pharmatec has been supplying pure media systems to the global pharmaceutical industry for 30 years. All over the world, our solutions provide everything required for a seamlessly integrated system infrastructure – from hot and cold generators to storage and distribution systems; from pre-configured units to highly customized solutions. Regardless of the application, our systems provide a seamless process from generation to distribution at the point of use, including the associated CIP systems.

About us

years of experience

installed systems

unique customers

countries

Downloads

Pure Media Systems Brochure

Service flyer

WFI generation journal article

There’s more than one way to produce pharmaceutical wateri

Energy-saving WFI Systems

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Frequently asked questions

WFI has traditionally been generated through the energy-intensive process of distillation, but the recent revision to monograph 0169 of the European Pharmacopoeia (EP) has now also made techniques other than distillation universally accepted. The revision has finally aligned the EP with the US and Japanese Pharmacopoeias in allowing more energy efficient alternatives. Syntegon acted on this regulatory change right as it took place and was among the first industry suppliers to introduce the new type of generation unit for WFI in Europe. Our MWFI system uses the “cold” membrane process of reverse osmosis, along with electrodeionization and ultrafiltration, in a modular, full-featured design. Storage can be either hot or cold.

In essence, the unit must produce water under tightly monitored conditions that eliminate impurities and prevent the growth of microorganisms. Regular sanitization of the unit using hot water or chemicals prevents the formation of biofilms. Syntegon’s systems offer both options. Monitoring all the processes in the production chain (in particular the integrity of the membranes) is essential to guaranteeing the microbial quality of the water, which is why Syntegon outfits its systems with a variety of sensors and measuring devices. We monitor total organic carbon (TOC), conductivity, and other important parameters of water quality throughout. An online microbe counter is also available as an option.

The operating cost differential depends primarily on the consumption level and the efficiency of the correspondingly sized thermal generation system (i.e. the number of distillation columns in the system). On the low end, for pilot and small-scale facilities with an annual consumption of around 5 million liters per year, typical savings are in the order of ~30%. On the high end, for large facilities with 40 million liters or more of annual consumption, savings can easily reach ~40%. These are typical savings that factor in maintenance and materials in addition to the utilities consumption. We invite you to get in touch for a tailored assessment of the savings potential in your particular facility.

Ozone as a treatment agent remains somewhat problematic to handle and difficult to measure accurately in solution. And since turning to hot storage (to avoid ozone treatment) no longer means bigger, more expensive, and energy-hungry generation systems, hot storage is a fully financially viable solution for many customers. With the hot WFI storage option now standard for the MWFI, customers need not compromise. But Syntegon offers comprehensive hot and cold storage and distribution options alike. The specific use case determines which storage type is the better option for each customer.

Interested in membrane-based pure media systems?

Country/Region

Membrane-based PW, HPW and WFI generation

Key benefits

Reliability

Serviceability

Sustainability

Features of our membrane-based pure media systems

Configuration flexibility

Energy efficiency

Footprint and serviceability

Use case scenarios

Interested?

Technical data of our membrane-based pure media systems

Configure-to-order selection

Service Agreements

Digital Solutions

Parts

Maintenance

Technical Support

Modernizations

Training

Expert Services

Why choose a Syntegon membrane-based pure media system?

We have the right technology and experience

Downloads

Read our latest pharma news

Frequently asked questions

Is the “cold” WFI generation process universally accepted by regulatory bodies?

How is the risk of microbial growth adequately mitigated in “cold” WFI generation systems?

What is the operating cost savings potential with “cold” WFI generation?

What are the drawbacks of “cold” WFI storage? Isn’t hot storage significantly more expensive?

Interested in membrane-based pure media systems?

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