In honor of Jack Lysfjord who
passed away on March 14, 2024, this bundle is 50%
off until the end of the year. PDA remembers Jack Lysfjord as an expert in the
field of Aseptic Processsing and he will be greatly missed. To learn more
about Jack please click
here
.
Sale! 50% off!
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displayed and will be reflected at checkout.
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.
Table of Contents
Table of Contents:
Volume 1 Click here to download>>>Detailed Table of Contents Preface by Irving J. Pflug,
PhD Introduction by Jack Lysfjord
Section 1:
Current Global Influences on Aseptic Processing
Regulatory Background to Aseptic Processing by Richard Johnson and
Gordon Farquharson
Development Requirements of Biopharmaceutical Parenteral Dosage Forms by
John Bontempo, PhD
BioPharmaceutical Theraputics Dosage Forms Delivery Systems and Current
Status of Extractables and Leachables In Respective Parenteral Dosage Forms
by John Bontempo, PhD
Vaccines; Moving into the Future by John Finkbohner, PhD
Section 2: Current Aseptic Processing Techniques
Container Preparation; Washing, Sterilization and Depyrogenation by
Johannes Rauschnabel, PhD, Patrizia Dittmer, and Thomas Kosian, PhD
Vial Processing; Accumulating, Conveying, Filling and Stoppering the Most
Common Parenteral Container by Alan Peterson
Checkweighing Fill Weight of Parenteral Product Is the Heart of Process
Quality by Alan Peterson
Filling Methods As They Apply to Parenteral Product Quality and
Biopharmaceutical Microdosing by Alan Peterson
Disposables - Single - Use Systems for Aseptic Processing and Filling
Operations by Eric Isberg
Parenteral Non-Vial Container Formats; Ampoules, Syringes, Cartridges,
Ophthalmics and IV Bags by Alan Peterson
Application and Insights for Lyophilization of Parenteral Products by Ed
Trappler
Todays Integration of the Lyophilizer; Automated Loading and Unloading
by Ernesto Renzi
Crimp Sealing Parenteral Vials by Roger P. Asselta, Lawrence (Larry)
Pepper III and F. William (Bill) Bogle
Inspection of Parenteral Products in Vials, Ampoules, Syringes and
Cartridges by Michel de la Montaigne, Pedro J. Mendez and Ryosaku
Tagaya
New Inspection Techniques for Aseptic Processing by James Veale,
PhD
Practical Things to Improve Aseptic Process Equipment System Operation ,
Reduce Interventions and Reduce Product Risk by Jack Lysfjord
Dealing with the Complexities of Control Systems and Systems Integration
by Terrance G. Petro
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, PhD
Section 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 Thilly
Section 4: Current Aseptic Clinical Trial Materials
Secondary Aseptic Processing for Clinical Trial Materials by Alisa
Wright
Section 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 Authors
About the Editor
Jack Lysfjord, PhD , was a Principal Consultant for
Lysfjord Consulting LLC. For over 26 years, Lysfjord held a variety of management
positions with Bosch Packaging Technology (formerly TL Systems Corporation) that
produced aseptic processing equipment for producing injectable drugs. He was 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 was
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.
