Handbook of Isolation Technology
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Handbook of Isolation Technology

Handbook of Isolation Technology


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About the Book

A must-have reference for scientists in both industry and academia, this Third Edition includes completely revised and updated sections on validation in multi-national and small companies, issues pertaining to the Code of Federal Regulations 21, process analytical technology, real-time monitoring, practitioner compounding, and European and Japanese approaches to validation. The fundamental concepts of validation are explicitly discussed including calibration and metrology, temperature measurements, validation of water systems as well as qualification and significant aspects of change control.

Table of Contents:
INTRODUCTION. Scope of Book. History of Parenterals. Characteristics of Parenterals. Types of Dosage Forms. Types of Packaging Systems. PRODUCT DEVELOPMENT. Overview. Vehicles. Development of Solutions. Development of Dispersed Systems. Development of Freeze Dried Powders. Commercial Formulations. MANUFACTURING. Overview. Contamination Control. Facilities. Water. Air. Personnel. Preparation of Components. Sterilization. Filtration. Filling. Sealing. Lyophilization. Aseptic Processing. Terminal Sterilization. Labeling. Secondary Packaging. Distribution and Storage. Barrier Technology. Other Advanced Manufacturing Technologies. QUALITY AND REGULATORY. Good Manufacturing Practice. Quality Assurance and Control Philosophy. Quality Control Tests. CLINICAL ASPECTS. Advantages and Disadvantages of Injectables. Routes of Administration. Hazards of Administration. Parenteral Combinations. Biopharmaceutical Considerations


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Product Details
  • ISBN-13: 9781420018707
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: CRC Press Inc
  • Language: English
  • No of Pages: 800
  • Returnable: N
  • ISBN-10: 1420018701
  • Publisher Date: 29 Apr 2007
  • Binding: Digital (delivered electronically)
  • No of Pages: 800
  • Returnable: N


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