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Aseptic Processing technology has changed with the use of Advanced Aseptic Processing techniques such as: Blow/fill/seal (BFS) isolators and Restricted Access Barrier Systems (RABS). By becoming informed of the current state of the
art, product contamination can be greatly improved. Products are changing with
the increasing dominance of biological and biotech products being produced
and it is imperative that manufacturers keep pace with these changes that can
save time and money, improve productivity and increase safety. We all need
to stay on top of "what is current?" Jack Lysfjord, together with more than 30 global subject matter experts, contributes invaluable pragmatic knowledge to this pursuit.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 11.6 MB)
Book wrote in 2009.
| | Hardcover | Digital |
Bundle Vol. 1 & 2 | | |
Volume
1 | N/A | |
Volume
2 | | |
Table of Contents:
Click here to download>>>Detailed Table of Contents
Volume 2
Quality Systems by Anders Vinther, PhD and Mary Beth Grace
Introduction to GAMP® 5 by Tony Margetts, PhD
GAMP® 5 Applied to Medical Devices by Tony Margetts, PhD
Aseptic Process Validation and Aseptic Process Simulation Studies by Hal
Baseman
Sterility Test Isolators by Patrice Cloue and Carmen Wagner, PhD
Rapid Microbiological Methods in Support of Aseptic Processing by
Michael Miller, PhDSection 3: Advanced Aseptic Processing Techniques
Improving Process Quality of Pharmaceutical Liquids-Aseptic Blow-Fill-Seal
Technology vs. Traditional Aseptic Processing by Chuck Reed
Isolators for Aseptic Manufacture of Parenterals by Jack Lysfjord
Restricted Access Barrier Systems (RABS) and the Application for Aseptic
Processing by Jack Lysfjord
Container and Component Transfer Methods by Johannes Rauschnabel,
PhD
Gloves and Glove Testing in Aseptic Processing by Johannes Rauschnabel,
PhD
Containment - Protecting People, Product and the Environment by James P.
Wood and Justin Farrell
Innovation in Aseptic Processing: Case Study Through The Development of A
New Technology by Benoit Verjans and Jacques ThillySection 4: Current Aseptic Clinical Trial Materials
Secondary Aseptic Processing for Clinical Trial Materials by Alisa
WrightSection 5: Pharmacy Compounded Aseptic Products
Compounded Sterile Preparations at Hospitals by E. Clyde Buchanan and
Philip J. Schneider
Pharmacy Aseptic Compounding of Parenteral Products by Michelle Morre and Hank Rahe
About the Editor
Jack Lysfjord, PhD, is Principal Consultant for Lysfjord
Consulting LLC. For over 26 years, Lysfjord has held a variety of management
positions with Bosch Packaging Technology (formerly TL Systems Corporation) that
produced aseptic processing equipment for producing injectable drugs. He is a
member of the International Society for Pharmaceutical Engineering (ISPE),
Parenteral Drug Association (PDA), American Association of Pharmaceutical
Scientists (AAPS), the American Glove Box Society (AGS), The Parenteral Society
(UK), The Isolator Users Group (UK), R3 Nordic (Nordic Clean Room Processing
Society) and Barrier Users Group Symposium (BUGS) of which he is Chairman. He is
a frequent speaker and course leader on the topics of aseptic processing, RABS
(Restricted Access Barrier Systems) and barrier isolator systems in the US,
Europe and Asia and has been the author and co-author for numerous technical
papers and articles. Lysfjord holds a B.S. in Mechanical/Industrial Engineering
from the University of Minnesota and an MBA from the University of St Thomas.