Rapid microbiological methods in the pharmaceutical industry
- 其他作者: Easter, Martin C.
- 出版: Boca Raton, Fla. : Interpharm/CRC ©2003.
- 稽核項: 1 online resource (ix, 277 pages) :illustrations.
- 標題: Pharmaceutical microbiology Methodology. , MEDICAL Pharmacology. , MEDICAL Nursing -- Pharmacology. , Methodology. , MEDICAL , Electronic books. , Pharmacy. , Microbiological Techniques. , Technology, Pharmaceutical. , MEDICAL Pharmacy. , Electronic book. , Pharmaceutical microbiology , Drug Guides. , MEDICAL Drug Guides. , Pharmacology. , NursingPharmacology.
- ISBN: 0203010876 , 9780203010877
- ISBN: 9781574911411 , 1574911414
- 試查全文@TNUA:
- 附註: Includes bibliographical references and index. Historical perspective on methods development / Anthony M. Cundell -- Microbiological methods of the pharmacopoeia : growth and recovery of microorganisms from pharmaceutical manufacturing environments / Klaus Haberer and Marc W. Mittelmann -- Overview of alternative rapid microbiological technologies / Paul J. Newby and Bob Johnson -- Labor-saving devices and automation of traditional methods / Peter Silley and A.N. Sharpe -- ATP bioluminescence and its use in pharmaceutical microbiology / Kirsty Wills -- Impedance / Peter Silley and Fiona Mortimer -- Traditional and automated rapid methods for species identification and typing / Kevin Tyler and Jeffrey M. Farber -- Techniques for detection of specific organisms and potential for DNA-based technologies / Richard Owen -- Alternative technologies for sterility testing / Amy Meszaros -- Limulus endotoxin test / Thomas J. Novitsky and H. Donald Hochstein -- A practical guide to validation / Kirsty Wills -- Regulatory recognition and acceptance / Edward A. Fitzgerald -- New technologies for microbiological assays / Larry J. Kricka.
- 摘要: Exploring new methods for finding better solutions to ensuring the microbiological safety of pharmaceutical products, this book provides the how tos for applying an effective system to assess the real microbiological hazards and hence quantify realistic risks. It details monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. Topics include labor-saving devices and automation of traditional methods, ATP bioluminescence in pharmaceutical microbiology, identification methods, regulatory recognition and ac.
- 電子資源: https://dbs.tnua.edu.tw/login?url=https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=123125
- 系統號: 005313621
- 資料類型: 電子書
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In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond?
來源: Google Book
來源: Google Book
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