Achieving sterility in medical and pharmaceutical products
著者
書誌事項
Achieving sterility in medical and pharmaceutical products
(Drugs and the pharmaceutical sciences, 64)
M. Dekker, c1994
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
Detailing the scientific principles underlying the achievement of sterility, this unique reference examines both a broad spectrum of practical, commonly used sterilization procedures and the methods available to confirm sterility-assessing the strengths and limitations of each technology.
Delineates current regulatory requirements for sterility-emphasizing the importance of aseptic processes in the medical establishment and the pharmaceutical industry!
Achieving Sterility in Medical and Pharmaceutical Products discusses sterilization approaches that utilize
saturated steam
dry heat
ethylene oxide
gamma radiation
sterile filtration
and more!
目次
The Need for Sterility
Sterility and Sterility Assurance
Sterilization by Gamma Radiation
Sterilization by Saturated Steam
Dry Heat Sterilization and Depyrogenation
Sterilization by Ethylene Oxide
Sterilization by Filtration
Aseptic Manufacture
Maintenance of Sterility
Parametric Release and Other Regulatory Issues
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