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USP water generation

Discussion in 'Pharmaceuticals (21 CFR Parts 210 & 211)' started by Dylan Brunjes, Aug 7, 2015.

  1. Dylan Brunjes

    Dylan Brunjes New Member

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    Has anyone had experience with replacing carbon beds with sodium bisulfite? Our company is thinking of heading this direction and it would be great to get some insight into the risks of installing a sodium bisulfite system.
     
  2. Tommy Leaton

    Tommy Leaton New Member

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    Well, The FDA has pretty good instructions on what you need to get Water for Injection (WFI). This is outlined in the High Purity Water System (7/93). I would note that the European Pharmacopoeia will only allow for distillation. USP states “distillation or a purification process proven to be equal to or superior to distillation.”

    If you want to get more information please check and update here.
     

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