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Drug, device and diagnostic manufacturing : the ultimate resource handbook / by Carol DeSain.

By: Material type: TextTextPublisher: Buffalo Grove, Ill. : Interpharm Press, Inc., 1993Edition: Second editionDescription: xv, 429 pages ; 24 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 0935184384
Subject(s): DDC classification:
  • 22 610.28 D.C.D
Contents:
Biomedical research/design -- Biomedical product development -- Regulatory requirements -- Facility qualification master protocol -- Documentation and document control -- Departmental organization/responsibilities -- Master validation protocol -- Quality assurance monitoring and control programs -- Clean rooms for aseptic processing -- Endotoxin testing and depyrogenation techniques -- Lyophilization -- Particulate monitoring and control for parenteral and implantable product manufacturing -- Physical sterilization techniques and validation -- Stability testing programs -- Disinfection programs -- Water purification and water quality testing -- Computer controlled process validation -- Safety programs.
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Includes bibliographies and index.

Biomedical research/design -- Biomedical product development -- Regulatory requirements -- Facility qualification master protocol -- Documentation and document control -- Departmental organization/responsibilities -- Master validation protocol -- Quality assurance monitoring and control programs -- Clean rooms for aseptic processing -- Endotoxin testing and depyrogenation techniques -- Lyophilization -- Particulate monitoring and control for parenteral and implantable product manufacturing -- Physical sterilization techniques and validation -- Stability testing programs -- Disinfection programs -- Water purification and water quality testing -- Computer controlled process validation -- Safety programs.

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