Puretech - Turnkey Pharmaceutical Water Treatment System

Started in 1983, Puretech has developed into a leading turnkey process engineering company specialising in purified water, highly purified water, water for injection (WFI), ultra filtration, pure steam, CIP/SIP, special gases and fluid processing systems to the pharmaceutical industry.

We manufacture high-quality purified water systems under our Genesys and Oasys brands, ultrafiltration / reverse filtration systems and pure steam systems.

GENESYS – HOT WATER SANITISABLE PURIFIED WATER GENERATION SYSTEM

The Genesys is recognised as the market leader in hot water sanitisable purified water generation systems. Key features include:

• Flowrates from 300L/hr to 10,000L/hr
• Unique modular design enables easy and low cost upgrade to higher flowrates
• Sophisticated GAMP4 control system with large colour, touch screen HMI
• Unit fitted with removable panels to provide security and safety, meeting EC directives
• USP28 compliant for purified water and WFI
• EP compliant for purified and highly purified water
• Integrated CIP system
• Full FAT, IQ and OQ prior to shipment
• RO/EDI recycles to minimise water sent to drain
• Water quality of <0.1µs/cm, <50ppb TOC, <10 cfu/ml and <0.25eu endotoxins
• Ionpure LX electrodeionisation unit with 150 cycles and 85oC warranty

OASYS – CHEMICALLY SANITISABLE PURIFIED WATER SYSTEM

The Oasys has been developed to complement the Genesys range. It is a chemically sanitised version of the Genesys with a simpler GAMP 4 compliant control system. The unit can be validated up to USP and EP standards with a full FAT being carried out at our works.

PURIFIED WATER AND WFI DISTRIBUTION SYSTEMS

Puretech have a wealth of experience in design, supply, installation and validation of purified water distribution systems. All work, from front end design through to system qualification is carried out in house. Standard designs are available for hot water or ozone sanitisation.

ULTRAFILTRATION / REVERSE OSMOSIS SYSTEMS

Modular skid mounted ultra filtration systems are available for water pre-treatment and low endotoxin or pyrogen free waster systems. Heat sanitisable reverse osmosis systems can be combined with hot water sanitisable softeners to provide total microbial control of the pre-treatment stage.

PURE STEAM SYSTEMS

A full turnkey package can be provided to include pure steam generator and clean steam distribution systems in full compliance with HTM2010 and HTM2031.

STAINLESS STEEL SKID SYSTEMS

Our investments have created a fully equipped manufacturing facility including dedicated FAT area for all products. Together with our in-house design facility this leads to the production of customised stainless steel fabrications such as:

• Skid mounted water / process systems
• Customised control systems
• CIP / SIP Systems
• Kill tank systems for biowaste decontamination control systems

Our in-house team of controls and software engineers can assist clients in all aspects of pharmaceutical process systems. Our staff develop standard and bespoke GAMP4 compliant systems to meet the client's URS utilising Siemens, Allen Bradley and Eurotherm products.

VALIDATION

To meet the stringent demands for high-quality validation documentation and execution, we have our own validation engineers who have experience of pharmaceutical water and process systems. We will facilitate the systems validation process by providing documentation meeting design and installation requirements.

A DQ/IQ/OQ documentation package can include design specifications, weld procedures / qualifications / logs, material certificates, as-built drawings, isometric drawings, video boroscoping, O&Ms, Commissioning Records and FAT/SAT.

We typically carry out over a 100 pharmaceutical contracts a year and have gained supplier approval to most of the major pharmaceutical companies including Abbott AstraZeneca, Boehringer Ingelheim, Cardinal Health, Chiron Vaccines, Eli Lilly, GSK, Merck, National Biotechnology Centre, Sanofi Aventis and Wyeth