View into future: Modular concepts for Purified and Highly Purified Water

PW-System Werner GmbH mit Heisswassersanitisierung (©Werner GmbH 2014) / PW-System Werner GmbH using Hotwater Sanitisation (©Werner GmbH 2014)

„Water treatment plants and distribution systems shall be designed, constructed and maintained so as to ensure a reliable source of water of an appropriate quality. They should not be operated beyond their designed capacity” EU Guidelines to Good Manufacturing Practice medical products for human and veterinary use. ANNEX 1 manufacture of sterile medicinal products.

This essential guide is also true for the reverse : a too large sized pharmaceutical water system inevitably causes high downtime, this can lead to microbiological deterioration. In many cases the current - especially but also the future demand for pharmaceutical water - not exactly predictable. The solution is a modular to expanding pharmaceutical water system.

This task was imposed in 2013 from Bionorica SE to Werner GmbH. Bionorica SE develops and produces since 1933 herbal medicines that combine the healing powers of nature with the latest knowledge from research and technology. The key for a reconciliation of high efficacy with good tolerability lies in the right combination of highly potent active ingredients. Bionorica SE developed and now sells market-leading products such as "Sinupret" in over 50 countries worldwide.

The task included a "State of the Art" Purified Water generation system with automatic hot-water sanitisation. In addition to the currently required power capacity of the system it was important  that  a simple and straightforward extension option for another 100 % capacity is possible in the future.

The system has been delivered end of 2013 after prequalification during FAT and consist of the following stages of construction:

- seriell operating softener unit (85 °C) capacity designed for 2 x 100 % extension
- recirculation device TS-PLUS for selective and independent thermal sanitisation of the softener and reverse osmosis, membrane degasser and cedi
- reverse osmosis extendable in different steps by using additional membranes without a change of the main system footprint size
- membrane degasser expendable by another module up to 200 % capacity
- electro deionisation expendable by another module up to 200 % capacity
- redox contol in order to switch temporary to activated carbon filters in case of chlorination by the water works

The modular PW system has been working for 7 months now to the full satisfaction of Bionorica SE. The first extension by an additional membrane element for reverse osmosis is implemented in the medium term. All further stages of long-term securing the necessary amounts of Purified Water by Bionorica SE.