Over the last 30 years, Pharmalab has been the leading supplier of plants producing water for injection, which meets international standards, including USP, IP, BP and JP. The plants are manufactured as per FDA’s current Good Manufacturing Practices (cGMP) and ASME requirements and follows the basic principle of Distillation by Thin Film Evaporation.
Our plant is designed to be crevice-free as crevices promote stagnation and stimulate bacterial growth. All columns are designed to ASME specifications and are approved by CE for PED regulations as per European Union requirements. All parts in the plant coming into contact with WFI and Pure Steam are electro polished, pipe joints are orbitally welded, gaskets are made from pure Teflon or pharmaceutical-grade silicon and the first column is a double tube sheet designed to prevent pure steam mixing with plant steam, should there be a weld joint failure in the tube sheet.
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