Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes

  • US 7,471,991 B2
  • Filed: 08/08/2006
  • Issued: 12/30/2008
  • Est. Priority Date: 05/06/2004
  • Status: Active Grant
First Claim
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1. A method for monitoring a pharmaceutical manufacturing process, said method comprising:

  • a) deriving an algorithm implemented in computer executable instructions that performs “

    boundary value analysis”

    on a pharmaceutical manufacturing hardware system using at least a filtration/purification system;

    b) performing “

    logic analysis”

    on said algorithm;

    c) integrating said algorithm implemented in computer executable instructions into said pharmaceutical manufacturing hardware system wherein boundary values are selected;

    d) monitoring said pharmaceutical manufacturing hardware system.

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