Shopping cart
Your shopping cart is empty

Show shopping cart...
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices


>>> simply register for our free GMP newsletter LOGFILE


GMP Specials

Filtration Handbook Series
€ 448.00
€ 479.36
  7% VAT included
Air and Gas, Integrity Testing, Liquids
Edition: July 2006
Filtration Handbook: Air and Gas
The perfect training guide to ensure that you and your employees understand complex filtration operations and all the regulatory expectations required to pass an FDA inspection.

This illustrated lecture series is dedicated to topics in the filtration of air and gases such as regulations, separation mechanisms, choices of filter types and materials, integrity testing, validation and trouble shooting. The topics are practically discussed in a presentation format with the "lecturer's" presentation following each slide in printed form.

Filtration Handbook: Integrity Testing
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.

Filtration Handbook: Liquids
Presents an illustrated lecture series directed to the filtration of liquids designed for training purposes. The benefit of this approach is the inclusion of the lecturer's amplification in printed form. Unlike oral presentations, the headline style limitations of slides are compensated by the unlimited time available for the reader's comprehension of the accessible text. The reader progresses at his own pace, never distracted by the rapid presentation of new topics interrupting the reflection on what was last said, as often happens in a lecture presentation. The text is layered in its information. Simple core answers deliver the essential information and when considered useful, the text is expanded to impart further details and background sufficient to utilize them. A list of further readings and references is included, primarily from peer-review journals.
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 numerous 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 - 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 - Liquids, Filtration Handbook - Integrity Testing,(both PDA/DHI), Filtration in the Biopharmaceutical Industry, Sterile Filtration - A Practical Approach, (both Marcel Dekker, Inc.), High Purity Water Preparation for the Semiconductor, Pharmaceutical and Power Industries, Pharmaceutical Water Systems and Sterile Filtration: A Practical Approach, as well as many professional papers and book chapters. A member of the American Chemical Society, the PDA, and the Filtration Society, Dr. Meltzer received the Ph.D 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.

They are the recipient of PDA's Distinguished Author Awards for 2003, 2004 and 2005.
PDA/DHI Publication
Practical Aseptic Processing Fill and Finish - Volume I and II