Pure Media Generation & Distribution

Pure media

Pure water (PW), high purity water (HPW), water for injection (WFI), and pure steam (PS) are essential utilities in pharmaceutical manufacturing. 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.

Our expertise

Membrane-based pure media generation

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

distillation-based-water-for-injection-system

Distillation-based pure media generation

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

Pure media storage and distribution

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

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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 our customers’ 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.

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

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. The supply of heating steam to the first column is all you need for operation; 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 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 requirements
Easy expansion thanks to a modular design

What is pure media?

Pure water (PW), high purity water (HPW), water for injection (WFI), and pure steam (PS) are essential utilities in pharmaceutical manufacturing. They are used for the preparation of the manufacturing equipment for production and as ingredients for the pharmaceutical products themselves.

Pure media generation process
Pharmaceutical facilities use their potable water supply to generate their pure media. Before this potable water can be fed to pure media generators, however, it needs to be suitably pre-treated in order to prevent fouling. Depending on the origin and quality of the water supply, different processes and treatment stages are employed to produce an adequate pre-treated water quality. Ultrafiltration and multimedia/active carbon filtration are typically the core unit operations of the pretreatment process.

Once the potable water has been suitably pre-treated, it is fed into a pure water generator. There it typically undergoes softening, reverse osmosis (RO), and electrodeionization (EDI) to generate pure water (PW) or high purity water (HPW). This PW and HPW can now be fed to water for injection (WFI) and pure steam (PS) generators for the production of those two ultra-high purity media.
WFI can be generated either through a “cold” membrane-based process with ultrafiltration (UF) as the final step or a “hot” or thermal process relying on distillation. Both approaches have their relative advantages and drawbacks but produce equally conforming WFI. PS is then generated through the evaporation of WFI.
Storage and distribution systems complete the highly integrated pure media supply infrastructure. Storage can be either hot (with thermal sanitization) or cold (with chemical sanitization) to prevent microbial growth and preserve the media quality.
In optimized installations, the technology mix is tailored to the specific use case to provide a seamless process from generation to distribution at the point of use, including the associated clean-in-place (CIP) systems.

Major process steps

pretreatment of the raw/potable water supply
generation of pure water (PW) or high purity water (HPW)
production of water for injection (WFI) from PW or HPW
generation of pure steam (PS) from WFI
storage and distribution of PW/HPW, WFI, and PS
regular sanitization of the entire infrastructure

The systems comprising Syntegon’s pure media solutions

Syntegon’s pure media 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.

Raw/potable water pretreatment system

Syntegon pretreatment systems are modular solutions that implement a highly tailored pretreatment process to fully address the needs arising from the origin and quality of the potable water supply. From removal of particulate matter to precise conditioning, our modular systems get the job done. And we don’t stop there. We offer you everything from concept design including water analysis to operation and maintenance protocols.

Pure water generation unit (PWGU)

Syntegon offers a modular, highly flexible solution for the generation of pharmaceutical-grade pure water (PW) and high purity water (HPW). Employing a full range of technologies including multi-layer filtration and ultrafiltration, as well as physical-chemical processes including reverse osmosis and electrodeionization, our PWGU systems are configured to precisely address your individual requirements. 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.

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Membrane-based water for injection system (MWFI)

Building on the PWGU system, Syntegon offers a turn-key solution for the “cold” membrane-based generation of pharmaceutical-grade water for injection (WFI). With an additional ultrafiltration (UF) module for the final reduction of endotoxins to meet WFI standards, the MWFI is a highly versatile solution that combines PW/HPW and WFI generation in a single unit. Storage can be either hot or cold. Our approach substantially reduces the footprint, energy consumption, investment costs, qualification expenses, and ongoing maintenance costs when compared to traditional distillation-based systems.

distillation-based-water-for-injection-system-02

Distillation-based water for injection system (Still)

Syntegon offers a skidded, highly flexible solution for the distillation-based (i.e. thermal) generation of pharmaceutical-grade water for injection (WFI) and pure steam (PS). 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 HPW of WFI quality at every subsequent process stage. Our proven approach meaningfully reduces the footprint and energy consumption.

Pure steam generator (PSG)

A single-column version of the Still, the PSG is a compact and efficient solution for the dedicated generation of pharmaceutical-grade pure steam (PS). 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. Standard configurations cover the complete standard output range of up to 5,000 kg per hour.

Storage and distribution (S&D)

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 cold storage and distribution of PW or WFI. Ozone can be added to protect against microbial contamination, with a UV system ensuring that the dissolved ozone is depleted during production. Hot storage recirculates WFI continuously. Cold taps are provided via sub-loops with integrated cooling modules.

Our solutions have got you covered

Technology

Regardless of the application – from hot and cold generators to storage and distribution systems, from pre-configured units to highly customized solutions – our technology portfolio provides a complete, seamless solution from generation to distribution at the point of use, including all associated CIP systems.

Reliability

The Syntegon subsidiary Pharmatec has been supplying pure media systems to the global pharmaceutical industry for 30 years.

Sustainability

Our advanced technology and modular design features best-in-class energy efficiency throughout. Our fully integrated solutions substantially reduce both operating costs and the carbon footprint.