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Pharmaceutical Solutions - Elga Process Water

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<strong>Pharmaceutical</strong>s<br />

Biotechnology<br />

Healthcare Products<br />

Cosmetics<br />

Contact Lens<br />

Medical Devices<br />

Neutraceuticals


• Main Offices<br />

With more than 150 local offices<br />

worldwide, we’re right there<br />

when you need us.<br />

<strong>Pharmaceutical</strong><br />

<strong>Water</strong> <strong>Solutions</strong><br />

Producing purified water, highly purified water,<br />

pyrogen free water and WFI to international<br />

pharmaceutical standards is a critical process<br />

2


<strong>Water</strong> is the most commonly used liquid in the<br />

<strong>Pharmaceutical</strong> industry, not only as an ingredient in<br />

many formulations, but also as a cleaning agent.<br />

The production of Purified <strong>Water</strong>, Highly Purified <strong>Water</strong>,<br />

Pyrogen Free <strong>Water</strong> and WFI to international<br />

<strong>Pharmaceutical</strong> standards is widely recognized as a critical<br />

process.<br />

Veolia <strong>Water</strong> <strong>Solutions</strong> & Technologies (VWS) has unparalleled<br />

technological experience and delivers complete<br />

solutions that meet and exceed these standards<br />

through compliance with:<br />

> Latest USP, JP and Ph Eur standards<br />

> cGMP requirements<br />

> GAMP validation control systems<br />

> FDA requirements<br />

> ISPE Engineering Guide<br />

> CE marking<br />

> IPPC environmental requirements<br />

The turn of the century has led to a new FDA approach<br />

to <strong>Pharmaceutical</strong> manufacturing. An ever-increasing<br />

emphasis is being placed on risk management, quality<br />

systems and manufacturing science. Due to the global<br />

nature of the <strong>Pharmaceutical</strong> industry in terms of manufacturing<br />

and regulations, these changes are taking<br />

place worldwide.<br />

As a world leader for process water, VWS uses the latest<br />

technologies available to improve manufacturing efficiency<br />

and reduce costs, without compromising process<br />

security and product quality. All aspects of our product<br />

development, project management and service offerings<br />

are managed to the highest quality standard to ensure<br />

that our dedicated team of experts are in tune with the<br />

market needs.<br />

3


Our local service centers provide parts from<br />

strategic spares to membrane replacements<br />

Customer<br />

Care<br />

The <strong>Pharmaceutical</strong> industry is one of the most demanding<br />

in the world. VWS, as a total service company, understands<br />

that it’s not just about our equipment complying<br />

with GMP, but also how we document what we do and<br />

how we manage our work for you.<br />

Our service starts with professional project management<br />

and superior validation methodology. Validation is built<br />

into our contract management and service philosophies,<br />

so that the principle of saying what you’re going to do,<br />

doing what you said you’d do and proving that you did as<br />

you said, is engrained in all aspects of our work.<br />

Our in-house team of specialists prepare the essential documents<br />

needed to support the installation, commis-sioning<br />

and maintenance of your purified water system.<br />

Our skid mounted purified water systems are<br />

designed to GAMP and GMP as a standard. Our proven validation<br />

package significantly reduces site installation and<br />

validation time, helping to minimize costs and shorten<br />

lead times.<br />

With more than 150 local offices worldwide, our qualified<br />

service engineers are on location, speaking your language<br />

and understanding your local needs. We offer a variety of<br />

flexible, cost-effective service contracts with short guaranteed<br />

response times to minimize your downtime.<br />

Whenever there’s a problem, we’ll be there until it’s solved.<br />

Our local service centers provide parts from strategic<br />

spares to membrane replacements when you need them.<br />

Furthermore, we understand your need for a new pure<br />

water installation and the investment this involves.<br />

This is why we bring you the ALL IN PACK® solution,<br />

which provides you with a complete commercial and<br />

technical solution, including: equipment supply,<br />

installation, system maintenance and a leasing package<br />

to meet all costs. This innovative package gives you peace<br />

of mind for your current and future needs without<br />

a large initial capital investment.<br />

As a customer, you can be safe in the knowledge that<br />

essential, service critical replacement consumables are<br />

always available. With over 10,000 parts in stock, we are<br />

committed to the success of your operation. Whatever,<br />

whenever and wherever you need us, we’re determined to<br />

exceed your expectations.<br />

4


On-Site Service<br />

Validation Services<br />

Project Management<br />

5


Packaged <strong>Water</strong> <strong>Solutions</strong><br />

ORION® NEW<br />

• Proven in over 100 installations worldwide<br />

• Thermal sanitisation of the purification steps offers sound microbial control<br />

• Operator panel available in a number of languages<br />

• Modular design with more than 80 configurations<br />

• No regeneration chemicals<br />

QUATTRO®-S<br />

• Economical solution for high purity water<br />

• Chemical sanitisation for microbial control<br />

• Intuitive microprocessor control<br />

• Security through I-button key<br />

• No regeneration chemicals<br />

Ionpro LX®<br />

• Minimised footprint<br />

• Compact, portable cabinet<br />

• Automatic sanitisation<br />

• Low noise operation<br />

TRITON NEW<br />

• Standard purified water package system incorporating production, storage<br />

tank and distribution<br />

• Well-proven technology: reverse osmosis, continuous electrodeionisation<br />

and ultra-violet disinfection<br />

• Designed for ease of operation and maintenance (i-button)<br />

POLARIS NEW<br />

• Comprehensive product range: multi effect and vapour compression distillers and<br />

pure steam generator<br />

• Efficient, effective and modular systems to meet high end <strong>Water</strong> For Injection<br />

demands<br />

• GMP, GAMP, FDA, CE & ISPE compliant<br />

• Pre-assembled and Factory Acceptance Tested prior shipment<br />

• <strong>Water</strong> For Injection range up to 25 000 l/h and Clean Steam range up to 7 950 kg/h<br />

NEXUS NEW<br />

• Fits Purified <strong>Water</strong> & <strong>Water</strong> For Injection applications<br />

• Pre-validated & pre-tested distribution and sanitisation skid<br />

• Perfect partner for vws generation systems<br />

• Ozone or hot water sanitisation of the storage tank and distribution loop<br />

• Full range up to 30 m 3 /h.<br />

6


VWS utilizes a risk-based approach to select the best<br />

water treatment systems to meet your needs. <strong>Water</strong><br />

for pharmaceutical purposes is used in a variety of<br />

applications with different levels of risk. As our client,<br />

you can match your expenditure to each application.<br />

All of our systems are validated, all are FAT tested, all<br />

are packaged to reduce on-site installation time and<br />

all come with our full product water quality guarantee.<br />

However, the systems differ in the process<br />

technology used, in the method of sanitization and in<br />

the type of control.<br />

In particular, the control philosophy and GAMP<br />

categorization have an effect on the intensity of the<br />

required validation testing.<br />

VWS uses a lifecycle costing model to establish<br />

your true cost of ownership over the lifetime of an<br />

installation.<br />

Relative Capital<br />

Investment<br />

Low Risk<br />

Applications<br />

Relative Lifecycle Cost<br />

Ionpro LX®<br />

RAPIDE Strata<br />

API synthesis Medical devices Ointments Ophthalmic solutions<br />

Cosmetics Granulation Final rinse Parenteral solutions Primary rinse<br />

Tablet coating API final isolation Cell culture<br />

ORION®<br />

QUATTRO® -S<br />

Critical Applications<br />

The graph shows the lifecycle costs compared<br />

to the capital investment and the level of<br />

application risk. It demonstrates the relative cost<br />

structures for a 4 m 3 /h system, where the lifecycle<br />

costs include utilities, major spares, consumables,<br />

estimated operator and service costs over a 10-year<br />

period. When matching expenditure to risk,<br />

the lifetime cost should be assessed together with<br />

the capital cost. For example, the capital plant<br />

investment for Ionpro LX® and QUATTRO® are<br />

similar, but the operating costs of the Ionpro LX®<br />

are higher because it has a less sophisticated<br />

degree of automation and validation; consequently,<br />

it is better suited for lower risk applications. At the<br />

other end of the scale, the ORION® has higher<br />

operating and capital costs due to its optimized<br />

automation, materials of construction and validation.<br />

The enhanced security this delivers makes the<br />

ORION® ideal for your most critical applications.<br />

VWS supplies a full range of engineered solutions from pre-treatment<br />

to sophisticated ringmain design.<br />

7


Veolia <strong>Water</strong> <strong>Solutions</strong> & Technologies (VWS), a subsidiary of Veolia<br />

<strong>Water</strong>. VWS is one of the world’s major designers of technological<br />

solutions and constructor of facilities for water treatment.<br />

With over 7 400 employees, the company has operations in more<br />

than 55 countries. VWS recorded revenue of €2.1 billion 2007.<br />

VWS Pharmaticeutical Group specialises in providing pharmaceutical<br />

water treatment technology solutions (process & waste water)<br />

and services.<br />

Global Headquarters<br />

L’Aquarène - 1, place Montgolfier<br />

94417 Saint-Maurice Cedex<br />

France<br />

Tel : +33 (0) 1 45 11 55 55<br />

Fax : +33 (0) 1 45 11 55 00<br />

pharma-info@veoliawater.com<br />

Europe<br />

Austria<br />

Mosetiggasse 3<br />

Tel: +43 (0) 1 665 0353-14<br />

Fax: +43 (0) 1 665 0353-22<br />

vwsaustria@veoliawater.com<br />

Benelux<br />

Wavre<br />

Tel: +32 (0)10 49 52 60<br />

Fax: +32 (0)10 49 52 61<br />

infovwstb@veoliawater.com<br />

Denmark<br />

Glostrup (Copenhagen)<br />

Tel: +45 (0) 70 20 50 26<br />

Fax: +45 (0) 43 45 35 24<br />

Finland<br />

Naantali (Turku)<br />

Tel: +358 (0) 2 43 06 317<br />

Fax: +358 (0) 2 43 06 323<br />

France<br />

Le Plessis-Robinson (Paris)<br />

Tel: +33 (0) 1 40 83 65 00<br />

Fax: +33 (0) 1 40 83 64 50<br />

info@vwater-sti.fr<br />

Germany<br />

Celle (Hannover)<br />

Tel: +49 (0) 5141 803 0<br />

Fax: +49-(0) 5141 803 242<br />

vertrieb.pharma@veoliawater.com<br />

Italy<br />

Milan<br />

Tel: +39 (0) 2 4299 210<br />

Fax: +39 (0) 2 4895 3726<br />

Ireland<br />

Celbridge, Co. Kildare<br />

Tel: +353 (1) 630 3333<br />

Fax: +353 (1) 630 3344<br />

sales.ireland@veoliawater.com<br />

Poland<br />

Warsaw<br />

Tel: +48 (0) 22 886 4406<br />

Fax: +48 (0) 22 886 4405<br />

Spain & Portugal<br />

Sant Cugat del Valles, Barcelona<br />

Tel: +34 935 1101 00<br />

Fax: +34 935 1101 09<br />

Sweden & Norway<br />

Solna (Stockholm)<br />

Tel: +46 8 587 663 00<br />

Fax: +46 8 587 663 10<br />

Switzerland<br />

Basle<br />

Tel: +41 61 361 65 61<br />

Fax: +41 61 361 65 63<br />

vertrieb.schweiz@veoliawater.com<br />

United Kingdom<br />

Marlow<br />

Tel: +44 (0) 1628 897000<br />

Fax: +44 (0) 1628 897001<br />

pharma.sales@veoliawater.com<br />

Latin America & Caribbean<br />

Argentina<br />

Buenos Aires<br />

Tel: +54 11 4302 7181<br />

Fax: +54 11 4302 7180<br />

vwsa@veoliawater.com<br />

Brazil<br />

Cotia<br />

Tel: +55 11 4617-4388<br />

Fax: +55 11 4617-4388 ext 108<br />

s-p@veoliawater.com<br />

Mexico<br />

Mexico City<br />

Tel: +52 555 366 6300<br />

Fax: +52 555 366 6363<br />

Africa<br />

South Africa<br />

Isando Gauteng<br />

Tel: +27 11 974 8161<br />

Fax: +27 11 974 8867<br />

vwssouthafrica@veoliawater.com<br />

Middle East<br />

Egypt<br />

Cairo<br />

Tel: +20 23 787 972 / 73<br />

Fax: +20 23 584 752<br />

Asia Pacific<br />

Australia<br />

Pyrmont<br />

Tel: +61 2 8572 0400<br />

Fax: +61 2 8572 0410<br />

China<br />

Shanghai<br />

Tel: +86 21 6391 3288<br />

Fax: +86 21 6391 3298<br />

vws.shanghai@veoliawater.com<br />

India<br />

Ahmedabad<br />

Tel: +91 79 258 31 156<br />

Fax: +91 79 304 06 299<br />

hpwd_export@doshion.com<br />

Japan<br />

Tokyo<br />

Tel: +81 35 441 7070<br />

Fax: +81 35 441 7071<br />

Korea<br />

Seoul<br />

Tel: +82 2 3147 1593<br />

Fax: +82 2 3147 1553<br />

Philippines<br />

Manila<br />

Tel: +63 2 809 4010<br />

Fax: +63 2 809 4017<br />

Taiwan<br />

Taipei<br />

Tel: +886 2 2278 1006<br />

Fax: +886 2 2278 1002<br />

South East Asia<br />

Singapore<br />

Tel: +65 6546 1110<br />

Fax: +65 6546 2553<br />

North America<br />

Vandalia, OH<br />

Tel: +1 937 890 4075<br />

Fax: +1 937 890 9925<br />

biopharm.info@veoliawater.com<br />

Puerto Rico<br />

Caguas<br />

Toll free: 1-800-564-3157<br />

Tel: +1 787 747 9439<br />

Fax: +1 787 747 0380

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