- Hygiene & Cleaning
View to the future: modular concepts for Purified and Highly Purified Water
" Water treatment plants and distribution systems should 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” (EG GMP Guide (2010), Annex 1 Manufacture of Sterile Medicinal Products).
At least as critical to the opposite conclusion of this statement has to be seen; a too large designed pharmaceutical water system will cause too high downtime that result in almost all cases in a microbiological degradation. In most cases, even with the finalized User Requirement Specification the current - but especially the future demand for pharmaceutical water is not exactly predictable by the future system operator.
So the solution is obvious, pharmaceutical water system must be modular designed and thus correspondingly extended. This task is increasingly being approached more and more to Werner GmbH. In general, the URS of the client contains no indication of future performance expansion of the water purification plant, so that initially a "State of the Art" PW generator system is created with automatic hot-water sanitisation. Werner designed, in many cases already in the basic design an extension option for an additional 50 to 100% of capacity.
The basic design of an extensible, pre qualificated Purified or Highly Purified Water System is divided into the following stages of construction:
- serial connected duplex softener (85 ° C) capacity sufficient for the final capacity
- recirculation device TS-PLUS to enable selective thermal sanitisation of the softener and the reverse osmosis with optional membrane degasser and CEDI
- Reverse osmosis expanded in steps by additional membrane elements without changing the dimensions of the overall system
- Membrane degasser, expandable with an additional module
- Electrodeionization (CEDI), expandable with an additional module
The modular Werner PW and HPW systems are working now for over 5 years to the full satisfaction of the individual operator. The first extensions by an additional membrane element of reverse osmosis have already been partially implemented after 12 months, all further stages securing the need for long-term amounts of purified water have not yet realized.
EnviroFALK PharmaWaterSystems GmbH
Maybachstraße 29
51381 Leverkusen
Germany
Phone: +49 2171 7675 0
email: info@envirofalk-pharma.com
Internet: http://www.envirofalk-pharma.com