Pharmaceutical Solutions - Elga Process Water
Pharmaceutical Solutions - Elga Process Water
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