Friday, June 01, 2007

Pharmaceutical Water Applications

We have been receiving requests for quotation and information on pharmaceutical water applications. In chemical engineering terms, the "unit operations" used to produce pharmaceutical grade water are generally the same, activated carbon, water softeners, reverse osmosis (RO), DI, service DI, electro-deionization (EDI), continuous deionization (CDI), ultrafiltration (UF) mixed beds, sub micron filtration, etc., but the design of the equipment is radically different.

In particular, a water system in a pharmaceutical plant will generally need to be "validated" to comply with the United States Pharmacopeia (USP). There are standards for Purified Water and Water For Injection (WFI) that must be adhered to. Depending upon the water quality, the concerns are for, but not limited to, pyrogens and bacteria. To give you a brief idea of the nature of the complexity, please review the FDA GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS.

Although we have seen it happen in the past, a water treatment equipment supplier should not simply assume that standard industrial, or commercial water treatment equipment can be installed in a pharmaceutical plant. Please do not be told otherwise, there are substantial differences in design, documentation, materials of construction, fabrication, construction, startup, standard operating procedures (SOP), and maintenance. As our sales manager often says "They don't know what they don't know".

Through key relationships, Res-Kem offers ready access to this expertise.

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