Compact water
A new water quality was established last year – Highly Purified Water (HPW). This water quality chemically and physically corresponds to that of Water for Injection (WFI), but is not produced by distillation. Its use for WFI applications is therefore not possible throughout Europe, but is accepted in the USA according to USP 26. Examples for possible HPW applications are sterile preparations for eyes and nose as well as the final rinse of vessels. The production of WFI if needed in large quantities often incurs a commensurate cost factor. Osmotron, a member of the Christ Water Technology Group, now offers a compact plant producing Highly Purified Water. The plant combines a double-stage reverse osmosis with an electrodeionisation (EDI) module Septrosan. Thus, the entire plant is hot water sanitisable at 80 to 85° centigrade. Osmotron injects supplies from 500 to 5,000 l/h of HPW with a conductivity of <0.1 mmho/m and a TOC content of <50ppb. The relevant microbiological values are <5 CFU/100 ml and <0.06 EU/ml for endotoxines and thus considerably beneath the profile required by the USP 26 and EP 5. The plant is made of stainless steel 316 L, orbitally welded and has a surface roughness – in contact with the product – of <0.8 mm. Time-consuming commissioning is not necessary since Osmotron inject is supplied ready to connect, pre-qualified (IQ/OQ) and furthermore conforms to the requirements of GMP, GAMP and the ISPE Engineering Guide.
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