Ultrapure Water Process Water Lab Water - Werner GmbH...alternatively PVDF-HP with bead and...

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Pharmaceutical Water Ultrapure Water Process Water Lab Water

Transcript of Ultrapure Water Process Water Lab Water - Werner GmbH...alternatively PVDF-HP with bead and...

Page 1: Ultrapure Water Process Water Lab Water - Werner GmbH...alternatively PVDF-HP with bead and crevice-free welding, Ra < 0.20 µm latest control technology Siemens S7 PLC controller

Pharmaceutical WaterUltrapure WaterProcess WaterLab Water

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2 | Company

FACTS & FIGURES

More than 40 years of success in the market of water treatment

45 employees (2017) and highly qualified cooperation partners

1 EU trademark AQUADEM® (demineralization cartridges)

1 patent APWS – Antistatic Pure Water System (semiconductor application)

Production area 1,200 sqm, 450 sqm office area

Broad range of water treatment plants – pharmaceutical water (PW, HPW, WFI), ultrapure water, process water, lab water

DIN ISO 9001:2015 certification

Certification according to § 19 WHG

Since 1974, the name WERNER has been a byword for the highest quality in water treatment and for innovative ultra-pure water technologies. For a variety of purposes we provide our customers with our individually engineered and constructed plants, which ensure the process reliability of the production of pharmaceutical water, process water, lab water and ultrapure water. Our innovative, turnkey and customized plants are being delivered to international clients in a wide range of different markets. These include, among others, pharmaceuticals, bio-technology / life science / medical technology, cosmetics / food / beverage, microelectronics / microstructures / electrical pro- duction, trade and small-scale industry.

PASSION AND COMPETENCE

Both our passion for purest water and the excellent know-how of our employees ensure that we can design and implement the opti-mum water treatment solution for each application.

PASSION FOR PUREST WATERINTRODUCING OURSELVES

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Company | 3

1974 Foundation of the GmbH out of the engineering office Werner by Wilhelm Werner and Hans Träger in Cologne

1978 GmbH – 100% owned by Hans Träger

1983 Relocation to Bergisch Gladbach, expansion in plant engineering for ultrapure water plants in the semiconductor industry

1994 First QM certification according to DIN ISO 9001:2008

1997 Submission of patent application – APWS (Patent No. 197 46 533.1-43)

1986 Joining of Ulrich Träger (parallel to studies)

1995 Relocation to Leverkusen. As second generation Ulrich Träger takes over the management of the company

2001 Appointment of Barbara Träger as managing director

1993 First pharmaceutical water project (Aqua Purificata) by combining Reverse Osmosis and CEDI

1997 Joining of Barbara Träger

2006 Unexpectedly Hans Träger passes away. Company shares are transferred to Ulrich Träger and Barbara Träger

2008 Beginning of active focusing on the business area of pharmaceutical water

MILESTONES WILHELM WERNER GMBH

A HISTORY OF SUCCESS

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4 | Services

ENGINEERING

Our committed and competent employees offer you a wide range of services throughout the entire life cycle of your water treat-ment plant: from the initial planning to maintenance and repair work. Services that we cannot offer ourselves, may, if necessary, be awarded to our certified cooperation partners.

FROM PLANNING TO COMMISSIONING

Each water treatment plant is planned carefully according to your specific requirements. This is done with the aid of the latest technologies and alternative materials as well as by taking into account – whenever possible – environmental aspects in order to optimize the water balance. After that, your plant is manufactured at our company in Leverkusen in compli-ance with the highest quality standards and is finally subject to a Factory Acceptance Test (FAT). We use all standard methods of connection technology, even under cleanroom conditions: orbital welding machines for pharmaceutical applications of stainless steel with AISI 316L; bead and crevice-free welding machines for PVDF-HP connection technology, IR welding (infrared) for PVDF and PP connections as well as standard connection technologies. If the FAT is successful, the plant is installed at your facility and, after instruction and training of the operating personnel, put into operation.

Gerne beraten wir Sie:GENERALAGENTURGEORG VON SCHMIDT-PAULIBachstraße 3350858 KölnTelefon 0221 9483246

BESTER SCHUTZFÜR SIE UNDIHRE LIEBEN.

07-28-093-01_4597.indd 1 28.07.16 09:23

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Mehr Power für Ihre Unternehmensprozesse und -leistungen

www.concept-pro.de

conceptpro | Herzbroicher Weg 50 | 41352 Korschenbroich | T. 02161.40269-18 | [email protected]

� Qualitätsmanagement-Beratung nach ISO 9001 � i:solution CAQ, die All-in-One QM-Software

Services | 5

PROCESS RELIABILITY DUE TO PERFECT SERVICE, MAINTENANCE AND PARTS AVAILABILITY

We provide a variety of service features and maintenance services: from basic and major maintenance services to calibration services to certified reference point measurement and even remote main-tenance via VPN tunnel. And, of course, we stock important com- ponents and aggregates as well as consumable supplies; further-more our framework agreements with regular suppliers ensure short-term delivery of spare parts.

Process reliability is our top priority, therefore we are investing heavily in the expansion of our service department.

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6 | Pharmaceutical water plants

OUR GREATEST STRENGTHPHARMACEUTICAL WATER PLANTS

With our modular concept of constructing purified or highly pu-rified water plants (as well as WFI systems based on membrane technology), capacity requirements of 100 LPH just as more than 25,000 LPH of pharmaceutical water can be met. Because each client has individual system and production requirements. All of our PW and HPW systems as well as the complete system lines comply with the guidelines of the PhEur, USP and JP as well as GMP and FDA, so they assure the production process, product quality and economic efficiency.

We regard ourselves as a competent partner and advisor in all stages of pharmaceutical water treatment: from consulting, plan-ning and design, to the whole construction and production of the plant in our own production facility, to the engineering of a storage and distribution system or, alternatively, the integration into an existing system – and even the all-in after-sales service including support during the PQ phase and a subsequent main-tenance concept.

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www.gemu-group.com

Membranventile für hygienische und sterile Anwendungen

Pharmaceutical water plants | 7

The validation of our pharmaceutical water plants is carried out according to the regulations of the FDA, cGMP, GAMP as well as the ISPE guidance. The implementation of the quality standard High-ly Purified Water (HPW) at June 1st, 2002 in the European Pharma- copoeia allowed a new plant design with an additional process step of depyrogenation after the treatment of PW. Thus, substanti-al investment and operating costs for the final rinse of containers of parenterals and equipment can be saved, as until then they had to be cleaned with WFI.

DEFINED VALIDATION PROCESS

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8 | Pharmaceutical water plants

Our Purified Water (PW) or Highly Purified Water (HPW) and WFI (Water for Injection) plants for the preparation of purified water according to PhEur, USP or JP are being delivered as pre-qualified compact plants, ready for connection. The compact package unit construction technique on a stainless steel skid provides all the required processing technologies, which will be adapted speci-fically to the prevailing quality of the potable water. The PW and HPW / WFI compact plants with a performance range from 100 to 25,000 LPH are composed of the following components:

double softening, serial connection, quality-controlled, alternative conditioning according to the drinking water ordinance (TVO)

recirculation system UV plus reverse osmosis, single- or double-stage construction optional membrane degasification for the reduction of CO2

electrodeionization CEDI optional hot water sanitizing at > 80 °C or chemical sanitization pipes of stainless steel 316L, Ra < 0.80 µm, orbital welding, alternatively PVDF-HP with bead and crevice-free welding, Ra < 0.20 µm

latest control technology Siemens S7 PLC controller with touch panel or panel PC

HPW / WFI systems are also equipped with an ultrafiltration 6,000 daltons, optionally with integrated automatic membrane testing.

INDIVIDUAL PW AND HPW / WFI PLANTSMEET YOUR NEEDS

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Straße der RTS06577 Heldrungen | Germany

Tel.: +49(0)3 46 73. 954-0 Fax: +49(0)3 46 73. 954-250E-Mail: [email protected]

Innovation made in Heldrungen

Maßgeschneiderte Edelstahlbehälterfür die Pharmaindustrie

Höchste Ansprüche an Qualität, Sicherheit und Zuverlässigkeit

www.behaeltertec.de

Pharmaceutical water plants | 9

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SWM-A Automatische Weichwasserüberwachung

Wasser Härte SensorenWasserenthärtung

FiltrationUmkehrosmose

Ultrafi ltration

www.spieglgmbh.de

Die SWM-A schützt sensible Verbraucher wie Umkehrosmose oder Dampfkessel vor Hartwasser

Die SWM-A ist mit einem Sensor als Detektor ausgerüstet. Wenn ein Härtedurchbruch erkannt wurde, zeigt die Steuerung eine Hartmeldung mit Alarmsignal an.

Ohne Chemikalien - Automatischer Betrieb.

WasseraufbereitungWater Treatment

10 | Process water plants

In many production processes an important role is entrusted to reliable water treatment and thus the persistently high quali-ty of the process water. We develop individual process water plants, storage and distribution systems as well as special so-lutions for automation – orientated to our customers demands and requests Materials contacting media as well as all other substances used for the production of our plants are being syn-tonized most accurately to customer-specific requirements

In order to fulfill highest purity requirements, we manufacture unitized Super-AQUADEM® polisher systems for capacities of up to 20,000 LPH, which reliably extract anions, metals and orga-nic compounds contained in the water. The maximum tolerable concentration of particles in the submicron range is ensured by either a downstream membrane filter or ultrafiltration. An additional scavenger, with special TOC adsorbers, bonds with the smallest organic compounds in ultrapure water. The ’’Total Organic Carbon“ value (TOC) can consequently be reduced to <0.5 ppb.

PROCESS WATER SOLUTIONSMEET YOUR NEEDS

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Leitfähigkeit von Rein- und Reinst-wasserLeitfähigkeit von PW, HPW und WFIRealisieren Sie mit dem Condumax CLS15D/16D zuverlässige Leitfähigkeits-messungen in Rein-, Reinstwasser- und WFI-Anwendungen. Die hochpräzisen Messwerte bilden die Basis für eine opti-male Qualität Ihrer Prozesse und Produkte.

CLS15DDer Condumax CLS15D arbeitet zuverlässig und genau in einem breiten Anwendungs-bereich. Er ist für eine geringe Wartung und eine lange Lebensdauer konzipiert und bietet ein hervorragendes Preis-Leistungs- Verhältnis.

CLS16DDer High-End-Leitfähigkeitssensor CLS16D verfügt über zahlreiche Zertifikate wie EHEDG, FDA und Bioreaktivitätstests nach USP Part <87> und <88> Class VI sowie hygienische Prozessanschlüsse.

MemosensDie digitale Memosens-Technologie ver- bindet höchste Prozess- und Datensicher-heit mit einfacher Handhabung. Die in den Sensoren gespeicherten Identifizierungs- und Kalibrierdaten sorgen für eine einfache Rückverfolgbarkeit.

www.de.endress.com/memosens

Endress+HauserMesstechnik GmbH+Co. KGColmarer Straße 679576 Weil am [email protected]

Flüssigkeiten exakt analysieren.

WERNER does not just provide off-the-peg solutions, but always develops customized solutions, such as our pa-tented Antistatic Pure Water System (APWS). It allows an increase of the apparent conductivity in ultrapure water in the sawing process of the semiconductor manufacture by individually dosing the CO2 dilution. Some more of our company’s innovations: Temperature control and cooling systems, or dosing systems for ultrapure water.

PATENTED APWS

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12 | Process water plants

We construct process water systems for the use in various indus-tries where the supply of ultrapure water and high hygiene requi-rements play a key role. Industrial sectors include:

FOOD AND BEVERAGE INDUSTRY The provision of completely demineralized and ultrapure water enables the stabilization of product-specific taste by a defined water quality for intermediate and final products or also the use of conditioned drinking water for controlled cleaning processes with treated drinking water. Our plants comply with legal and official regulations as well as the individual room-specific or seasonal requirements of our customers.

MEDICAL, MICROELECTRONICS AND SEMICONDUCTOR INDUSTRY

Whether it concerns minimum structure widths, as in the case of wafer production, or, like in medical-care centers, an unaffected safe diagnosis, our systems and plants ensure the supply of ultrapure water of consistently high quality. On top of that, we’re developing solutions for process water recycling. These include, for example, reclaim system units for process wastewater and wastewater plants for the direct feeding and different specific customized solutions.

INDUSTRY AND TRADE Especially surface treatment during production by using ultra-pure water involves our entire know-how about water treatment. We offer small and large process water systems for the chemical industry, automotive industry and suppliers, electronics sector, textile laundry as well as metal industry and trade.

PROCESS WATERFOR VARIOUS INDUSTRIES

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Verfahrenstechnik

ZinD Verfahrenstechnik Dammweg 7a, D-55130 Mainz

tel.: + 49 (0) 61 31 - 144 80 - 0 fax: + 49 (0) 61 31 - 144 80 - 29

e-Mail: [email protected] internet: www.zind-vt.de

Partner FÜr Filtration und anlagenbau ZertiFiZiert iso 9001 KundenwÜnsche Know how MiKroFiltration starKe ingenieurleistugenFiltrationstechnologie Filtration Fullservice KoMPetenZ FilterKerZen wein integritätstest ultraFiltration cross Flow Filtration audit ceberatung qualiFiZierte Mitarbeiter Fest-FlÜssig-trennung Massgeschneiderte lösungen Filter-KerZen tieFenFilterKerZen sterilFilter gehäuse endFiltration Mit MeMbranFilterKerZen FlexibeltieFenFilterschichten ModulFilter KerZenFilter vlieslagen niedrige eMissionswerte biolöslichsuPPort tieFenFilterschichten teaMworKs ZieleK u n d e n Z u F r i e d e n h e i t

ihr erFolg

unsere leistung

Anzeige Zind VT 210x297mm p.B Wasse -27.07.2016 1 27.07.2016 14:35:36Zind_DEC129330.indd 1 28-07-2016 12:22:16

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14 | Lab water purification

Laboratory water is used for analytics in laboratories or re-search and development departments for a wide variety of purposes: washing and cleaning of glasses, reagent prepara-tion, particle measurement or sample dilution, water for qua-litative analyses, steam production and lots more. This water – usually classified as type II according to ISO 3696 or ASTM D 1193 – is being produced by our plants on the basis of re-verse osmosis, electrodeionization or ion exchange. In addition, lab water is also used as feed water for different highly critical treatment steps for the production of ultrapure water (type I). It is then available for a range of life science applications – micro-biology, HPLC, PCR, cell culture, electrophoresis and others. Ideally, we combine both system levels – generation of lab water and ultrapure water – to create a customer-specific, needs-based concept.

LAB WATER PURIFICATION SYSTEMS AND SMALL ULTRAPURE WATER PLANTS

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Lab water purification | 15

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16 | Lab water purification

Our AQUADEM® regeneration department takes over all regenera-tion services for mixed bed resin: from 2 liter cartridges to 100 l cartridges of any brand. This is done by means of two fully auto-matic regeneration columns. Upon request, our qualified emplo-yees can also check the entire water treatment equipment on that occasion and make sure defective parts are exchanged before they reconnect the cartridge on-site. The wide range of ion exchangers and specialty products we supply includes:

Mixed bed resin – regenerable / disposable High-Capacity HC II – mixed bed resin – regenerable Purest resin (semiconductor grade) Mixture of activated charcoal, acid-washed Special adsorber – organic scavenger Cation exchanger

As one of the few companies owning regeneration facilities in Eu-rope we carry out documented batch testing and thus guarantee the highest capacity while consistently maintaining high quality. Besides the use of latest technology and high-quality chemicals, an environmentally friendly waste water neutralization according to §19 WHG (water legislation) and a modern regeneration pro-cess with documented batch monitoring, too, ensure the capacity and quality of the regeneration process of mixed bed resin.

ALL-ROUND SERVICEFOR LAB AND ULTRAPURE WATER

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Lab water purification | 17

Kundenspezifische UV-Anlagen für die: • Desinfektion von Prozess-, Trink- und Abwasser• Restozonvernichtung und TOC-Reduzierung im

Reinstwasser• Nassoxidation mittels UV-Bestrahlung zum

Abbau organischer Wasserinhaltsstoffe (AOP)

UV-EL GmbH & Co. KGMoritzburger Weg 6701109 Dresden - Germany

+49 (351) 88 38 31 [email protected]

www.uv-el.de

Germany49 (351) 88 38 31 04

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Ihr kompetenter Partner für:• Leitfähigkeitsmessgeräte• Leitfähigkeitsmesszellen• Kundenspezifi sche Entwicklungen• SMD - Technik/Bestückung• Umkehrosmose/RO-Steuerung• Elektronik Klein-/Großserien• EMV-Service

ELWA GmbH • Im Löwental 79 • 45239 EssenTel.: 0201 79 62 15 • Fax.: 0201 79 62 11 • [email protected]

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18 | Ultrapure water systems

Depending on the intended purpose, ultrapure water systems in either laboratories, research or production facilities have to meet different requirements. Before beginning a project, we analyze the daily requirements of ultrapure water, determine additional application-specific treatment processes, supervision criteria, va-lidation aspects and further parameters, so the system complies

with these specific requirements. All our ultrapure water systems are suitable for the production of ultrapure water (type I). The feed water needs to be pretreated water, purified by reverse osmosis, an ion exchanger, electrodeionization or distillation. Some small plants may even be operated directly with drinking water.

ULTRAPURE WATER SYSTEMSFOR SPECIFIC REQUIREMENTS

Zum Scheider Feld 3851467 Bergisch-Gladbach022 02 / 84130www.pekutec.de

Behälter- und Apparatebau

Kompetenz in Kunststoff

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Pekutec-Aufkleber-2.pdf 24.04.2009 11:27:34 Uhr

Behälter-Apparate- und Rohrleitungsbau

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Ultrapure water systems | 19

KIESEL Steriltechnik GmbHEngelsberg 375015 Bretten, Germany

Fon +49 7252 9637-10Fax +49 7252 9637-20

[email protected]

Edelstahlkomponenten

für die sterile Verfahrenstechnik... made for all

... alles aus einer Hand!

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WETEA-WASSER-TECHNISCHE ANLAGENWILHELM WERNER GMBH

Maybachstraße 29D – 51381 LeverkusenTel.: +49 2171 7675-0Fax: +49 2171 7675-10Email: [email protected]