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Filtration Handbook: Integrity Testing - Hardcover

Maik W. Jornitz; Theodore H. Meltzer

 
9781930114500: Filtration Handbook: Integrity Testing

Inhaltsangabe

This complete guide explains the proper performance of filter integrity testing by clarifying its relationship to bioburden concerns and assessing its role in filter validation. It offers practical approaches to appropriate use of integrity testing, wetting and temperature requirements, the Bubble Point test, diffusive airflow testing and much more. Numerous regulatory citations and references complete this invaluable book.

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Über die Autorin bzw. den Autor

Maik W. Jornitz is Group Vice President Product Management at the Sartorius Headquarters North America, Edgewood, USA. With close to 20 years of experience in separation technologies and regulations, Jornitz supports the biopharmaceutical industry on a world-wide basis. As a member of the PDA Board of Directors, Jornitz has been part of multiple PDA task forces, for example the Technical Report #26 task force, and program committee member. He is also a member of ISPE, ASTM, DIA and BFS. He is the author and co-author of numberous professional papers and book chapters on membrane filtration, integrity testing, and validation studies. He is co-editor and author of the books Filtration in the Biopharmaceutical Industry, Sterile Filtration - A Practical Approach, this most recent book; Filtration handbook - Air and Gas, Filtration Handbook - Liquids and Filtration Handbook - Integrity Testing, both published by PDA/DHI. He holds several patents related to biopharmaceutical process equipment. Mr. Jornitz received his Diploma in Process Engineering at the College for Advanced Technology in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

Theodore H. Meltzer, based in Bethesda, Maryland, is a consultant on filtration and high-purity water preparations to the pharmaceutical and semiconductor industries. With more than 40 years of experience in membrane separations, Dr. Meltzer holds four patents, and is the author, co-author, or co-editor of Filtration Handbook: Air and Gas, Filtration Handbook: Liquids, Filtration Handbook: Integrity Testing (both PDA/DHI), Filtration in the Pharmaceutical Industry, Filtration in the Biopharmaceutical Industry (both Taylor & Francis.), Pharmaceutical Water Systems, as well as many professional papers and book chapters. A member of the American Chemical Society, the PDA, and the Filtration Society, Dr Meltzer receive the PhD degree in physical-organic chemistry from the University of Chicago, Illinois. He pursued postdoctoral work in polymer mechanical properties at Princeton University, Princeton, New Jersey.

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