The UK-based company said that the new ORION TTS has been developed in response to demands of users who need 'maximum microbiological security'.
ORION TTS incorporates the same pre-engineered, modular design as the other units in the ORION range, and meets the latest Good Automated Manufacturing Practice (GAMP) and current Good Manufacturing Practice (cGMP) requirements as well as those of the ISPE (International Society of Pharmaceutical Engineering) Baseline Pharmaceutical Engineering Guide on Water and Steam Systems, according to ELGA.
The water purification process commences with two water softeners in series, to remove hardness. The heart of ORION TTS is a combination of reverse osmosis and continuous electro-deionisation, which provides chemical-free deionisation. All of the process units, including the pre-treatment softeners, are hot water sanitisable which provides an additional level of microbial security for the whole system.
"Hot water sanitisation is the safest method and the easiest to validate," said Tanja Loehe, Pharmaceutical Market Manager for ELGA Process Water.
The Orion TTS is made of stainless steel, and this includes the pre-treatment softeners and pipework. Complete validation documentation and pre-delivery tests (FATs and provisional installation qualification), together with full skid assembly, ensure fast-track project execution, according to ELGA Process Water.