Distillation-based pure media systems

Syntegon offers a flexible, turn-key solution for the distillation-based (i.e. thermal) generation of pharmaceutical-grade pure steam (PS) and water for injection (WFI). Whether a single, dual, or triple mode solution, our robust technology is based on natural circulation distillation. All that is required for operation is the supply of heating steam to the first column; all other modules are heated in an energy-efficient manner utilizing the heat generated during the preceding process stage. The sterile steam is condensed to high-purity water of WFI quality at every subsequent process stage. Our proven approach meaningfully reduces the associated footprint and energy consumption.

Product brochures

Key benefits

Reliability

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

Serviceability

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

Efficiency

The compact, skidded system is an energy-efficient thermal system. Our technology meaningfully reduces operating costs.

Configuration flexibility

Syntegon’s distillation-based pure media systems are robust, proven solutions that can be easily and quickly configured to meet your specific requirements. All configuration options are pre-tested and readily available. With a wide production range of both WFI and PS, the skidded systems are suitable for clinical and commercial manufacturing facilities alike.

Process efficiency and robustness

Syntegon’s distillation technology offers energy-efficient GMP generation of WFI and PS with only 3-5% blow-down. And with an all-SS construction, low mechanical stress on the heat exchanger, as well as a low scaling tendency with a bell-type separation system instead of a demister, the system is superbly robust.

Footprint and serviceability

Our distillation systems feature a pre-fabricated, skidded drop-in configuration that can be rapidly delivered, installed, qualified, and put into operation. And whether delivered as a stand-alone solution or integrated system, the system configuration is always highly hygienic and accessible, making maintenance quick and easy.

Pure steam (PS) and water for injection (WFI) are essential utilities in pharmaceutical manufacturing that have long been produced with distillation-based generation systems. Syntegon’s distillation technology offers energy-efficient GMP generation of WFI and PS with only 3-5% blow-down. With an all-SS construction, low mechanical stress on the heat exchanger, as well as a low scaling tendency with a bell-type separation system instead of a demister, our systems are superbly robust. And with a patented droplet separation system to remove any residual pyrogens, the quality of the generated PS and WFI is assured to be conforming at all times.

Benefits

Reliable supply of pharmaceutical-grade PS and WFI
Configuration flexibility to meet customer-specific requirements
Energy-efficient distillation technology with minimal blow-down
Superb robustness with low mechanical stress and scaling tendency
Patented droplet removal system for assured residual pyrogen removal

Our thermal generation technology is both highly versatile and efficient. Whether as a single, dual, or triple mode solution, our robust technology is based on natural circulation distillation. All that is required for operation is the supply of heating steam to the first column; all other modules are heated in an energy-efficient manner utilizing the heat generated during the preceding process stage. The sterile steam is condensed to high-purity water of WFI quality at every subsequent process stage. Our proven approach meaningfully reduces the associated footprint and energy consumption.

Benefits

Reliable supply of pharmaceutical-grade PS and WFI
Versatile single, dual, or triple mode solutions
Configuration flexibility to meet customer-specific requirements
Energy-efficient thermal systems with lower operating costs
Drop-in installation with excellent accessibility for easy maintenance

A precise analysis of your requirements ensures that the right amount of water and steam 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 the cold storage and distribution of 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 PS 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

Use case scenarions

Pure steam

Single column unit for the generation of PS with low mechanical stress on the heat exchanger with integrity check without dismantling

Pure steam and water for injection

Single, dual, or triple mode distillation units for the generation of WFI and/or PS with a low scaling tendency

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.

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Technical data of distillation-based pure media systems

only

blow-down

PS up to

kg/hr

WFI up to

l/hr

storage and distribution up to

l/hr

Technical data

	PS	WFI	Storage and Distribution
Container	up to 500-5,000 kg/hr	up to 500-12,000 l/hr	up to 38,500 l/hr
Processing range container	thermal degassing membrane degassing	thermal degassing membrane degassing dual mode (WFI or PS)	double pump station steam sterilization (SIP) UV lamp TOC measurement cold storage with sanitization 85C hot storage with sanitization 121C cold storage with ozone

WFI

Storage and Distribution

Container

up to 500-5,000 kg/hr

up to 500-12,000 l/hr

up to 38,500 l/hr

Processing range container

thermal degassing
membrane degassing

thermal degassing
membrane degassing
dual mode (WFI or PS)

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

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Maintenance

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Technical Support

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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 that is 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.

years of experience

installed systems

unique customers

countries

Downloads

Pure Media Systems Brochure

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Interested in distillation-based pure media systems?

Country/Region

Distillation-based PS and WFI generation

Key benefits

Reliability

Serviceability

Efficiency

Features of our distillation-based pure media systems

Configuration flexibility

Process efficiency and robustness

Footprint and serviceability

Use case scenarions

Interested?

Technical data of distillation-based pure media systems

Configure-to-order selection

Service Agreements

Digital Solutions

Parts

Maintenance

Technical Support

Modernizations

Training

Expert Services

Why choose a Syntegon distillation-based pure media system?

We have the right technology and experience

Downloads

Read our latest pharma news

Interested in distillation-based pure media systems?

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