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1 Pharmaceuticals Biotechnology Healthcare Products Cosmetics Contact Lens Medical Devices Neutraceuticals
2 Main Offices With more than 150 local offices worldwide, we re right there when you need us. Pharmaceutical Water Solutions Producing purified water, highly purified water, pyrogen free water and WFI to international pharmaceutical standards is a critical process 2
3 Water is the most commonly used liquid in the Pharmaceutical industry, not only as an ingredient in many formulations, but also as a cleaning agent. The production of Purified Water, Highly Purified Water, Pyrogen Free Water and WFI to international Pharmaceutical standards is widely recognized as a critical process. Veolia Water Solutions & Technologies (VWS) has unparalleled technological experience and delivers complete solutions that meet and exceed these standards through compliance with: > Latest USP, JP and Ph Eur standards > cgmp requirements > GAMP validation control systems > FDA requirements > ISPE Engineering Guide > CE marking > IPPC environmental requirements The turn of the century has led to a new FDA approach to Pharmaceutical manufacturing. An ever-increasing emphasis is being placed on risk management, quality systems and manufacturing science. Due to the global nature of the Pharmaceutical industry in terms of manufacturing and regulations, these changes are taking place worldwide. As a world leader for process water, VWS uses the latest technologies available to improve manufacturing efficiency and reduce costs, without compromising process security and product quality. All aspects of our product development, project management and service offerings are managed to the highest quality standard to ensure that our dedicated team of experts are in tune with the market needs. 3
4 Our local service centers provide parts from strategic spares to membrane replacements Customer Care The Pharmaceutical industry is one of the most demanding in the world. VWS, as a total service company, understands that it s not just about our equipment complying with GMP, but also how we document what we do and how we manage our work for you. Our service starts with professional project management and superior validation methodology. Validation is built into our contract management and service philosophies, so that the principle of saying what you re going to do, doing what you said you d do and proving that you did as you said, is engrained in all aspects of our work. Our in-house team of specialists prepare the essential documents needed to support the installation, commis-sioning and maintenance of your purified water system. Our skid mounted purified water systems are designed to GAMP and GMP as a standard. Our proven validation package significantly reduces site installation and validation time, helping to minimize costs and shorten lead times. With more than 150 local offices worldwide, our qualified service engineers are on location, speaking your language and understanding your local needs. We offer a variety of flexible, cost-effective service contracts with short guaranteed response times to minimize your downtime. Whenever there s a problem, we ll be there until it s solved. Our local service centers provide parts from strategic spares to membrane replacements when you need them. Furthermore, we understand your need for a new pure water installation and the investment this involves. This is why we bring you the ALL IN PACK solution, which provides you with a complete commercial and technical solution, including: equipment supply, installation, system maintenance and a leasing package to meet all costs. This innovative package gives you peace of mind for your current and future needs without a large initial capital investment. As a customer, you can be safe in the knowledge that essential, service critical replacement consumables are always available. With over 10,000 parts in stock, we are committed to the success of your operation. Whatever, whenever and wherever you need us, we re determined to exceed your expectations. 4
5 On-Site Service Validation Services Project Management 5
6 Packaged Water Solutions ORION NEW Proven in over 100 installations worldwide Thermal sanitisation of the purification steps offers sound microbial control Operator panel available in a number of languages Modular design with more than 80 configurations No regeneration chemicals QUATTRO -S Economical solution for high purity water Chemical sanitisation for microbial control Intuitive microprocessor control Security through I-button key No regeneration chemicals Ionpro LX Minimised footprint Compact, portable cabinet Automatic sanitisation Low noise operation TRITON NEW Standard purified water package system incorporating production, storage tank and distribution Well-proven technology: reverse osmosis, continuous electrodeionisation and ultra-violet disinfection Designed for ease of operation and maintenance (i-button) POLARIS NEW Comprehensive product range: multi effect and vapour compression distillers and pure steam generator Efficient, effective and modular systems to meet high end Water For Injection demands GMP, GAMP, FDA, CE & ISPE compliant Pre-assembled and Factory Acceptance Tested prior shipment Water For Injection range up to l/h and Clean Steam range up to kg/h NEXUS NEW Fits Purified Water & Water For Injection applications Pre-validated & pre-tested distribution and sanitisation skid Perfect partner for vws generation systems Ozone or hot water sanitisation of the storage tank and distribution loop Full range up to 30 m 3 /h. 6
7 VWS utilizes a risk-based approach to select the best water treatment systems to meet your needs. Water for pharmaceutical purposes is used in a variety of applications with different levels of risk. As our client, you can match your expenditure to each application. All of our systems are validated, all are FAT tested, all are packaged to reduce on-site installation time and all come with our full product water quality guarantee. However, the systems differ in the process technology used, in the method of sanitization and in the type of control. In particular, the control philosophy and GAMP categorization have an effect on the intensity of the required validation testing. VWS uses a lifecycle costing model to establish your true cost of ownership over the lifetime of an installation. Relative Capital Investment Low Risk Applications Relative Lifecycle Cost Ionpro LX RAPIDE Strata API synthesis Medical devices Ointments Ophthalmic solutions Cosmetics Granulation Final rinse Parenteral solutions Primary rinse Tablet coating API final isolation Cell culture ORION QUATTRO -S Critical Applications The graph shows the lifecycle costs compared to the capital investment and the level of application risk. It demonstrates the relative cost structures for a 4 m 3 /h system, where the lifecycle costs include utilities, major spares, consumables, estimated operator and service costs over a 10-year period. When matching expenditure to risk, the lifetime cost should be assessed together with the capital cost. For example, the capital plant investment for Ionpro LX and QUATTRO are similar, but the operating costs of the Ionpro LX are higher because it has a less sophisticated degree of automation and validation; consequently, it is better suited for lower risk applications. At the other end of the scale, the ORION has higher operating and capital costs due to its optimized automation, materials of construction and validation. The enhanced security this delivers makes the ORION ideal for your most critical applications. VWS supplies a full range of engineered solutions from pre-treatment to sophisticated ringmain design. 7
8 Veolia Water Solutions & Technologies (VWS), a subsidiary of Veolia Water. VWS is one of the world s major designers of technological solutions and constructor of facilities for water treatment. With over employees, the company has operations in more than 55 countries. VWS recorded revenue of 2.1 billion VWS Pharmaticeutical Group specialises in providing pharmaceutical water treatment technology solutions (process & waste water) and services. Global Headquarters L Aquarène - 1, place Montgolfier Saint-Maurice Cedex France Tel : +33 (0) Fax : +33 (0) pharma-info@veoliawater.com Europe Austria Mosetiggasse 3 Tel: +43 (0) Fax: +43 (0) vwsaustria@veoliawater.com Benelux Wavre Tel: +32 (0) Fax: +32 (0) infovwstb@veoliawater.com Denmark Glostrup (Copenhagen) Tel: +45 (0) Fax: +45 (0) Finland Naantali (Turku) Tel: +358 (0) Fax: +358 (0) France Le Plessis-Robinson (Paris) Tel: +33 (0) Fax: +33 (0) info@vwater-sti.fr Germany Celle (Hannover) Tel: +49 (0) Fax: +49-(0) vertrieb.pharma@veoliawater.com Italy Milan Tel: +39 (0) Fax: +39 (0) Ireland Celbridge, Co. Kildare Tel: +353 (1) Fax: +353 (1) sales.ireland@veoliawater.com Poland Warsaw Tel: +48 (0) Fax: +48 (0) Spain & Portugal Sant Cugat del Valles, Barcelona Tel: Fax: Sweden & Norway Solna (Stockholm) Tel: Fax: Switzerland Basle Tel: Fax: vertrieb.schweiz@veoliawater.com United Kingdom Marlow Tel: +44 (0) Fax: +44 (0) pharma.sales@veoliawater.com Latin America & Caribbean Argentina Buenos Aires Tel: Fax: vwsa@veoliawater.com Brazil Cotia Tel: Fax: ext 108 s-p@veoliawater.com Mexico Mexico City Tel: Fax: Africa South Africa Isando Gauteng Tel: Fax: vwssouthafrica@veoliawater.com Middle East Egypt Cairo Tel: / 73 Fax: Asia Pacific Australia Pyrmont Tel: Fax: China Shanghai Tel: Fax: vws.shanghai@veoliawater.com India Ahmedabad Tel: Fax: hpwd_export@doshion.com Japan Tokyo Tel: Fax: Korea Seoul Tel: Fax: Philippines Manila Tel: Fax: Taiwan Taipei Tel: Fax: South East Asia Singapore Tel: Fax: North America Vandalia, OH Tel: Fax: biopharm.info@veoliawater.com Puerto Rico Caguas Toll free: Tel: Fax:
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