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Practical Aseptic Processing: Fill and Finish, Vol I By Jack Ed Lysfjord

Ebook Download Practical Aseptic Processing: Fill and Finish, Vol I By Jack Ed Lysfjord

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Sales Rank: #4709769 in Books
Published on: 2009-04-01
Original language: English
Number of items: 1
Dimensions: 9.30" h x 1.10" w x 6.00" l, .0 pounds
Binding: Hardcover
405 pages

From the Publisher

Key Topics of Volume 1 includes:

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

About the Author
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.

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