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Image of - Validation of Pharmaceutical Processes Sterile Products | 2nd Edition
Validation of Pharmaceutical Processes Sterile Products | 2nd Edition

Validation of Pharmaceutical Processes Sterile Products | 2nd Edition

by Carleton

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

Highlights

  • binding-icon

    9780824793845

    ISBN

  • binding-icon

    Carleton

    Author

  • binding-icon

    856

    Pages

  • binding-icon

    1660 gm

    Weight

  • langauage-icon

    English

    Language

  • date-icon

    2006

    Year

  • edition-icon

    2nd Edition

    Edition

  • binding-icon

    Hardcover

    Binding

₹4945

₹5495

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

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