"Automated Cleaner"

Thermisch sanitiserbares EDI-Modul ©Werner GmbH 2015

Thermisch sanitiserbare Werner RO-Module ©Werner GmbH 2015

Water treatment systems of any kind (except distillation) generally provide favorable living conditions to microorganisms, so a suitable sanitization procedure has to be applied regularly. Experience has shown that this must be applied at least annually. Even in the EG GMP Guide and the ISPE Baseline Pharmaceutical Engineering is noted that “every equipment has to be designed in accordance to a good and easy cleaning and disinfection possibility”.

Consequently in the design of a pharmaceutical water system appropriate arrangements for the sanitization have to be applied. For a water treatment plant we can differentiate between the chemical - and thermal sanitization (> 80 ° C).

Chemical Sanitization

Each pharmaceutical water system (whether PW or HPW) can be chemically sanitized with the appropriate device (CIP system and integrated storage tank). Due to the low resistance of reverse osmosis membranes and CEDI modules to oxidizing agents mainly H2O2 (batch concentration to 0.5%) and peracetic acid have been established (up to 2%) with exposure times of 30-60 minutes as a disinfectant. Furthermore  the market also offers user-friendly finished products for chemical sanitization as Minncare ™ or Puristil®.

Both finished products are delivered as a kit with all the necessary test sticks for preparation and rinse concentration. The rinse time and/or regeneration times of CEDI modules up to 10 hours must be taken into account. The proof of the disinfectant freedom is passed over a fast-track tests. A complete automation is excluded by manually leading detection almost.

Thermal sanitization

Thermal stable reverse osmosis membranes and CEDI- modules are available now since around 2001. The thermal sanitization of PW and HPW systems has become significantly common in recent years. Reverse osmosis membranes are available for a long time in hot water-resistant design. However, the thermal sanitization, post  to the RO only in recent years also at the 2nd stage processing - are applied - the CEDI module.

So the thermal sanitization has been proven for an automatic application and validation very easy. If the system is equipped with this technology the whole water purification including the microbiological very critical softening unit can be full automatized heated up to 85 °C in fixed cycles e.g. over the weekend. After a appropriate holding time (typical 30 to 60 min) the system can be cooled down for production. The whole temperature ramp can be easy recorded by a printer.

Through the use of refractory materials (pipes, softening, etc.) and especially the corresponding RO membranes and CEDI modules as well as the necessary measuring and control technology (PLC) are characterized thermally sanitized generation systems over an up to 30% higher investment, which is overvalued in relation to a significant simplified qualification and validation in many cases.

During Achema 2015 Werner GmbH presents a qualified and fully automatic thermal sanitization PW system with a capacity of 400 l/h.