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OASYS Purified Water Systems

OASYS Purified Water Systems

OASYS Purified Water Systems

Product catalog summary
Material Specifications
The Oasys Purified Water System is constructed with high-quality materials such as polyethylene for the softened water tank, FRP for reverse osmosis, and FDA-approved materials for CEDI. Pipework is made from 316 and 316L stainless steel with an internal surface finish of less than 0.5 µm Ra. The frame and control cabinet are made from 304 stainless steel.
Technical Specifications
The system operates on electrical services of 380/415V, 3 Phase, 50Hz, offering flexible outputs from 300 to 10,000 liters per hour with a conversion rate of 75%.
Water Quality and Requirements
The system produces Purified and Highly Purified water in compliance with USP, EP, and JP standards. Product water quality includes conductivity of less than 0.1 µS/cm, TOC of less than 100 ppb, and bacteria levels of less than 10 CFU/ml. Feed water must be potable, free from organics, with total hardness less than 5 ppm as CaCO3, and a temperature range of 10 – 30°C.
System Components and Operation
Key components include a softened water tank, reverse osmosis membranes, continuous electro deionisation (CEDI), and optional ultraviolet irradiation or ultrafiltration units. The system allows for semi-automatic chemical sanitisation and features a sophisticated control system with data logging and remote access capabilities.
Applications
Purified water is used in the preparation of non-sterile products, water for injection, and pure steam. Highly Purified water is used where bacterial endotoxins need to be controlled.
Design and Compliance
The Oasys system complies with cGMP guidelines, ISO 9001 procedures, ASME BPE criteria, and GAMP guidelines. It is validated to meet regulatory and client standards, ensuring safety and quality.
Overview
The document provides detailed specifications and operational guidelines for the Oasys series of purified water systems, designed specifically for the pharmaceutical industry by Telstar Puretech.
Specifications
The Oasys models range from 300 l/hr to 8000 l/hr flow rates, with a consistent conversion rate of 75%. Dimensions vary by model, with larger units available upon request. The systems are designed to meet specific client requirements, with options for future expansion.
Water Quality Standards
The systems produce water that meets US and European Pharmacopoeia standards, with specified levels for conductivity, TOC, bacteria, and endotoxins. They are capable of producing both Purified Water (PW) and Highly Purified Water (HPW).
Feed Water Requirements
The systems require potable water with specific parameters: SDI < 3, total hardness < 5 ppm, free chlorine < 0.05 ppm, iron < 0.1 ppm, temperature between 10-30°C, and pressure between 2-6 bar. Compressed air must be oil-free and instrument grade.
System Components
Key components include a pre-filter, storage tank, high-pressure pump, RO membranes, membrane degasser, CEDI module, and optional UV/UF unit. The process involves pre-treatment, high-pressure pumping, RO filtration, degassing, and ionic contaminant removal.
Control System
The Oasys systems feature a touch screen HMI for easy operation and monitoring, with data logging and integration capabilities with BMS, DCS, or SCADA systems. The control system supports turnkey operations, enhancing safety and operational efficiency.
Customization and Support
Telstar Puretech offers customization to meet individual site requirements and provides comprehensive support including design, project management, validation, installation, commissioning, and maintenance.
Technical Data
Material specifications include polyethylene tanks, FRP reverse osmosis, FDA-approved CEDI materials, and stainless steel pipework and frames. Electrical requirements are 380/415V, 3 Phase, 50Hz.
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Catalog excerpts

OASYS Purified Water Systems-1

Technical data Operating principle Based on feed of 500 ppm TDS, 15o Celsius. Each system is designed on client exact requirements Units can be delivered in larger frame to allow future flowrate increase. Larger units are available on request Purified Water Systems Material specifications The pretreated (softened) water is passed throuh a filter housing (typically 5 µm) and analysed for free Chlorine prior to entering the RO feed tank. The filtered water then enters the stainless storage tank, if the tank is full the softened water is returned to the raw water tank to ensure constant movement to minimize the risk of bacterial proliferation. The softened water is then pumped at high pressure using a stainless steel multistage centrifugal pump, through the RO membranes. The RO permeate is then fed through a membrane degasser to remove dissolved Carbon Dioxide, followed by a CEDI unit in order to remove ionic contaminants. The purified water is then passed through an optional UV irradiator unit before being fed to the storage vessel. PRE-FILTER STORAGE TANK SANITARY HIGH PRESSURE PUMP RO MEMBRANES Feed water requirements • Softened water tank Polyethylene • Reverse osmosis FRP • CEDI LX FDA approved materials • Pipework 316 Stainless steel Dairy tube pre CEDI, outlet pipework 316L Stainless Steel, orbital welded, Internal surface finish <0.5 µm Ra • Frame 304 Stainless Steel • Control cabinet 304 Stainless Steel. • General potable water free from organics, colloids and suspended matter: SDI<3 • Total hardness < 5 ppm as CaCO3 • Free chlorine < 0.05 ppm • Iron < 0.1 ppm as Fe • Temperature 10 – 30°C • Pressure 2 - 6 bar. Services: Electrical 380/415V; 3 Phase; 50Hz. Compressed Air Oil free, instrument grade >6 bar. MEMBRANE DEGASSER CEDI MODULE UV/UF UNIT Attribute Conductivity (µS/cm) TOC (ppb) Bacteria (TVC CFU/ml) Endotoxins (EU/ml) Typical product water quality Oasys US Pharmacopoeia PW <0.1 <1.3 @ 25 C (Stage 1) <100 <500 <10 <100(3) <0.05 (UF option) N/A HPW = Highly Purified water; PW = Purified water; (3) FDA recommended action limit Control system The Oasys utilises the latest technology with touch screen HMI to allow ease of operation and monitoring. The Oasys allows control and monitoring from a single interface with data logging facilities and links to user systems eg, BMS, DCS or SCADA. The Oasys control system has the flexibility to operate complete turnkey packages allowing customers to reduce costs and simplify operation using a single access interface for pre-treatment, purification, storage and distribution. The Oasys control system ensures safe operation, protecting the system and the operator, giving you confidence and peace of mind. The Oasys is manufactured to suit client individual site requirements, Telstar Puretech work with our customers so that our system matches their needs, an example of standardization for the customers benefit. As a company who work to supply water purification solutions only within the Pharmaceutical Industry we offer comprehensive support to customers including system design, project management, validation, installation, commissioning and on-site maintenance. For further information contact your nearest sales office, details below. Telstar Av. Font i Sagué, 55 Parc Científic i Tecnològic Orbital 40 08227 Terrassa (Spain) T +34 937 361 600 F +34 937 859 342 Puretech Perrywood Business Park, Salfords Redhill, Surrey (England) RH1 5DZ T +44 (0) 1737 378000 F +44 (0) 1737 378055 www.telstar-lifesciences.com BR-OASYS-EN-1305 Telstar Puretech reserves the right to improvements and specifications changes without notice. Telstar North America 1504 Grundy’s Lane Bristol, PA 19007 (USA) T +1 215 826 0770 F +1 215 826 0222

 Open the catalog to page 1
OASYS Purified Water Systems-2

Purified Water Systems Trusted technology, safely implemented Design & construction features The Oasys Purified Water System is designed to generate Purified water in accordance with the International Pharmacopoeial specifications for Purified or Highly Purified water. The system has been designed to allow chemical sanitisation of the complete unit including the pipework feeding the Purified water into the storage vessel. The Oasys unit utilizes the following major components within a fully protected skid so that the system can be kept clean and prevent any injuries to operators during sanitisation....

 Open the catalog to page 2
OASYS Purified Water Systems-3

Purified Water Systems Trusted technology, safely implemented Design & construction features The Oasys Purified Water System is designed to generate Purified water in accordance with the International Pharmacopoeial specifications for Purified or Highly Purified water. The system has been designed to allow chemical sanitisation of the complete unit including the pipework feeding the Purified water into the storage vessel. The Oasys unit utilizes the following major components within a fully protected skid so that the system can be kept clean and prevent any injuries to operators during sanitisation....

 Open the catalog to page 3
OASYS Purified Water Systems-4

Purified Water Systems Trusted technology, safely implemented Design & construction features The Oasys Purified Water System is designed to generate Purified water in accordance with the International Pharmacopoeial specifications for Purified or Highly Purified water. The system has been designed to allow chemical sanitisation of the complete unit including the pipework feeding the Purified water into the storage vessel. The Oasys unit utilizes the following major components within a fully protected skid so that the system can be kept clean and prevent any injuries to operators during sanitisation....

 Open the catalog to page 4
OASYS Purified Water Systems-5

Technical data Operating principle Based on feed of 500 ppm TDS, 15o Celsius. Each system is designed on client exact requirements Units can be delivered in larger frame to allow future flowrate increase. Larger units are available on request Purified Water Systems Material specifications The pretreated (softened) water is passed throuh a filter housing (typically 5 µm) and analysed for free Chlorine prior to entering the RO feed tank. The filtered water then enters the stainless storage tank, if the tank is full the softened water is returned to the raw water tank to ensure constant movement...

 Open the catalog to page 5

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