Practical Aseptic Processing Fill and Finish, Volumes 1 and 2 (single user digital version)

Feb 2015
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PDF Single user
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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.

Book written in April, 2009

Available to download. Prior to purchase please view the download instructions.
Format: PDF (1 file 7.57 MB)

Bundle Vol. 1 & 2
Volume 1
Volume 2

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

    Volume 2
    Click here to download>>>Detailed Table of Contents

  • 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, 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.