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Telstar Technologies, S.L.
GENESYS Purified Water Systems

GENESYS Purified Water Systems

Product catalog summary

Material Specifications
The system is constructed using high-grade materials, including 316L Stainless Steel for the softened water tank, reverse osmosis, and pipework, ensuring durability and hygiene compliance. The frame and control cabinet are made from 304 Stainless Steel.

Purified Water Systems
The system processes pretreated water through filtration, reverse osmosis (RO), and continuous electro deionization (CEDI) to produce purified water, followed by UV irradiation before storage.

Control System
The Genesys control system features a touch screen HMI for easy operation and monitoring, supporting integration with systems like BMS, DCS, or SCADA, and offers data logging capabilities.

Model Specifications
Genesys models vary in flow rates from 300 to 6,500 l/h, with a consistent conversion rate of 75%, designed for future upgrades in flow rate.

Product Water Quality
The system ensures high-quality water with conductivity less than 0.1 μS/cm, TOC below 100 ppb, and bacteria count under 10 CFU/ml, meeting US and European Pharmacopoeia standards.

Feed Water Requirements
Feed water must be potable, free from organics, with specific limits on hardness, chlorine, iron, temperature, and pressure.

Operating Principle
The system is designed for safe operation, featuring automatic hot water sanitization and a fully protected skid to prevent operator injuries.

Key Components
Includes a softened water tank, reverse osmosis unit, CEDI, and UV/ultrafiltration units, all designed to meet stringent water purification standards.

Unique Selling Points
The system offers automatic sanitization, flexible output, constant monitoring, and compliance with regulatory standards. It is designed for easy upgrades and minimizes wastewater.

Applications
Purified water is used in non-sterile product preparation, cleaning solutions, and as a starting material for water for injection. Highly purified water is used where endotoxin control is critical.

Design & Construction Features
The Genesys system complies with cGMP guidelines and international standards, ensuring high-quality construction and performance. It includes quality plans and factory acceptance testing for assurance.

Overview
The document provides detailed information about Telstar-Puretech's Genesys Purified Water Systems, designed to produce Purified and Highly Purified water in compliance with various international standards such as USP, EP, JP, and cGMP guidelines.

Key Features

Automatic hot water sanitization and secure operation with lockable panels.
Flexible output range from 100 to 10,000 liters per hour, with easy upgrade options.
Continuous monitoring of Reverse Osmosis (RO) status and cleaning alerts.
Constructed from 316L stainless steel with a high-quality internal finish, compliant with ASME BPE standards.
Advanced control systems with data logging and paperless chart recording, compliant with GAMP and 21 CFR part 11.
Minimizes wastewater and integrates flexibly with proven technologies.

Applications
Purified water is used in non-sterile product preparation, rinsing, and cleaning solutions, while Highly Purified water is used in medicinal products where endotoxin control is necessary.

Design and Construction

Follows ISO 9001, ASME BPE, and GAMP guidelines.
Includes specific Quality Plans (DQ, IQ, OQ) and factory acceptance testing (FAT) for performance assurance.

Technical Specifications

Materials: 316L stainless steel for tanks and pipework, 304 stainless steel for frames and control cabinets.
Electrical requirements: 380/415V, 3 Phase, 50Hz.

Water Treatment Process

Softened water is filtered and analyzed for chlorine before entering the RO feed tank.
High-pressure pumping through RO membranes, followed by degassing and CEDI for ionic contaminant removal.
Final purification through UV irradiation before storage.

Control System
The Genesys system features a touch screen HMI for easy operation and monitoring, with capabilities for data logging and integration with user systems like BMS, DCS, or SCADA.

Model Specifications
The document lists various Genesys models with flow rates ranging from 300 to 6,500 liters per hour, with dimensions provided for each model.

Product Water Quality

Conductivity, TOC, bacteria, and endotoxin levels are specified for both Purified and Highly Purified water, meeting stringent pharmacopoeia standards.

Feed Water Requirements

General potable water with specific limits on hardness, chlorine, iron, temperature, and pressure.

Catalog excerpts

Operating principle Technical data Model flowrate (1) Genesys 1A Genesys 2A Genesys 3A Genesys 4A Genesys 5B Genesys 6B Genesys 7B Genesys 8B (1) (2) Actual flowrate dependent on feedwater temperature and site feed water quality. Each system is designed on client exact requirements Units can be delivered in larger frame to allow future flowrate increase Purified Water Systems 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. Material specifications Feed water requirements • Softened water tank 316L Stainless Steel vessel • Reverse osmosis 316L Stainless Steel • CEDI LX FDA approved materials • 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 5 – 30°C • Pressure 2 - 6 bar. Services: Electrical 380/415V; 3 Phase; 50Hz. Compressed Air Oil free, instrument grade >6 bar. The purified water is then passed through a UV irradiator unit before being fed to the storage vessel. Control system Attribute Conductivity (μS/cm) TOC (ppb) Bacteria (TVC CFU/ml) Endotoxins (EU/ml) Typical product water quality Genesys 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 The Genesys utilises the latest technology with touch screen HMI to allow ease of operation and monitoring. The Genesys allows control and monitoring from a single interface with data logging facilities and links to user systems eg, BMS, DCS or SCADA. The Genesys 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 Genesys control system ensures safe operation, protecting the system and the operator, giving you confidence and peace of mind. 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 01 903 1110 I 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

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Purified Water Systems Trusted technology, safely implemented Design & construction features The Genesys 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 automatic hot water sanitisation of the complete unit including the pipework feeding the Purified water into the storage vessel. A choice of quality Telstar-Puretech introduce the Genesys, opening a new chapter in pure water delivery. Telstar-Puretech Genesys Purified water systems are designed...

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Technical data Operating principle Actual flowrate dependent on feedwater temperature and site feed water quality. Each system is designed on client exact requirements Units can be delivered in larger frame to allow future flowrate increase Purified Water Systems 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...

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