WATER FOR INJECTION GENERATION PLANT

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.
This process involves a shell and tube heat exchangers (columns) where heat transfer is done by falling film evaporation. Very high temperatures are reached for every drop of water produced, thus ensuring sterility levels demanded for WFI. Separation of the Pyrogenic load is achieved through centrifugal forces generated during the upward movement of the steam.

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  • The plant is completely made with SS 316L (DIN 1.4435) stainless steel with active surfaces being electro polished.
  • Double tube sheet for first heat exchanger where boiler steam is used.
  • The insulation is made of glass wool covered by AISI 304 stainless steel sheet.
  • All contact parts to WFI are electro polished with state-of-the- art technology.
  • All pipes and tubes as per ASME BPE stamping with less than 0.5 Ra.
  • The frame is made of AISI 304 stainless steel.
  • The piping system is manufactured with electro polished pipes being orbital welded with sanitary fittings and pharmaceutical-grade gaskets.
  • Expansion joint design for tube-to-tube sheet joints.
  • Two Specially designed top coolers as per cGMP.
  • PLC based operation with all required inter locks and validated logic with skid mounted AISI 304 stainless steel control panel.
  • Complete documentation to serve international audit requirements.

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