No chance for microbes
New packaged water purification system provides maximum microbiological security

Elga Process Water has a new addition to its Orion range of packaged water purification systems. The high-performance Orion TTS has been developed for users who need maximum microbiological security.

The heart of the Orion TTS is a combination of reverse osmosis and continuous electro-deionization to produce 500–6,000 l/h of high-purity water without the need for chemical treatment. An optional ultrafiltration unit allows it to produce Highly Purified Water PhEur. The new water purification system incorporates the same pre-engineered, modular design as the other units in the Orion range, and meets the latest GAMP and cGMP requirements as well as those of the ISPE Baseline Pharmaceutical Engineering Guide on Water and Steam Systems.
The purification process starts with two water softeners in series. These remove hardness which might otherwise cause scaling downstream. They are provided with hardness sensors to monitor the softened water and initiate regeneration, ensuring that
there is no possibility of over-running even if the feed water hardness varies. Where chlorine is present in the feed water, activated carbon can be combined with the softener resins.
The softened water is filtered to 5 µm before entering a stainless steel break tank. The tank simplifies hydraulic control of the Orion, enables product water to be recirculated during periods of low demand, houses the sanitization heater and forms the basis of an integral cleaning in place (CIP) system.
A PLC system with software that is fully validated in accordance with GAMP controls not only the Orion TTS unit itself but also peripheral equipment such as the purified water storage tank and distribution system.

Hot water sanitization
Continuous recirculation of the product water maintains microbiological quality even when there is no demand. Every component, including the pre-treatment softeners, can be sanitized with hot water to provide an additional level of microbial security. “Hot water sanitization is the safest method and the easiest to validate,” explains Tanja Loehe, Pharmaceutical Market Manager for Elga Process Water. “Orion TTS can be heated to above 80 °C, the minimum temperature for effective sanitization.” Complete validation documentation and pre-delivery tests (FATs and provisional installation qualification), together with full skid assembly, save time in project planning, design and installation.