OZON – a safe alternative in cold storage

© 2020 Werner GmbH, Ozone System

Since the revision of the Ph.EUR for WFI in April 2017, cold, ozonized storage and distribution have gained significantly higher importance in meeting the highest microbiological requirements. Werner has already accumulated numerous experiences in this area.

While the actual preparation technology, with its components unstable against oxidizing agents such as reverse osmosis membranes, CEDI modules, and ultrafiltration, must still be sanitized cyclically at 85°C, the storage and distribution system can even be continuously treated with ozone.

In newly constructed storage and distribution systems, microbiologically safe quality can be maintained consistently with low ozone concentrations of 20 to a maximum of 50 ppb. Concentrations above 50 ppb are mostly only found in older systems, some of which have been retrofitted with ozone generators.

A critical point, however, remains the measurement of ozone concentration, as there is no traceable standard for calibrating the measuring devices. The detection limit of established devices is < 5 ppb, so pharmaceutical companies with ozone-critical products understandably refrain from continuous ozonation, opting instead to ozone only at night or on weekends.

The latest generation of Werner ozone generators features an extremely compact design and can be scaled from 0.8 g O3/h to well over 10.0 g O3/h:

- High safety against recontamination through highly effective, systemic protection
- Production of high-purity ozone directly from water (in situ) using solid electrolytes (PEM technology)
- High ozone concentrations, precisely dosed with optional analytical display of ozone production
- Modular device design (1.5 to 5 gO3/h per cell), up to 40 gO3/h (1 master and 7 slave units)
- Optional integrated ozone analytics with extensive internal data storage and safe logic
- Materials and seals compliant with FDA (CFR) 21, 177.1550
- 10" touch display with selectable language: German, English
- Integrated monitoring and display of flow rate, pressure, and conductivity

Werner has demonstrated significantly low microbiological results over long periods through cold storage with ozone in numerous water systems for HPW (Highly Purified Water), guaranteeing suitability and effectiveness even for cold-stored M-WFI generators.