Parenteral quality control : sterlity, pyrogen, particulate, and package integrity testing
著者
書誌事項
Parenteral quality control : sterlity, pyrogen, particulate, and package integrity testing
（Advances in parenteral sciences, 5）
M. Dekker, c1994
2nd ed., rev. and expanded
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
This second edition details current methods of testing parenteral quality control and discusses new techniques and emerging trends. It combines principles with practical information on how the tests are conducted, their strengths and limitations, and possible forthcoming changes. Coverage includes global testing requirements; new issues and approaches involving retesting of lots that failed initial sterility tests; and new technologies such as barrier systems for conducting sterility testing.
目次
- Sterility testing
- Pyrogen testing
- particulate matter testing
- package integrity testing
- example of standard operating procedure for sterility testing by direct inoculation
- example of standard operating procedure for sterility testing by membrane filtration
- example of methods used to clean, assemble, sterilize, and make final connections with membrane filtration equipment
- aseptic procedures at the laminar flow workbench
- comparison of various LAL methods
- proposed changes for the USP XXII section on particulate matter in injections.
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