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Pharmaceutical Dosage Forms - Parenteral Medications: Volume 2: Facility Design, Sterilization and Processing book cover

3rd Edition

Pharmaceutical Dosage Forms - Parenteral Medications Volume 2: Facility Design, Sterilization and Processing

Edited By Sandeep Nema, John D. Ludwig Copyright 2010
418 Pages 90 B/W Illustrations
by CRC Press

406 Pages
by CRC Press
Also available as eBook on:
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and... Read more

Volume 2:

  1. Asceptic Manufacturing Facility Design

    2. Mark Caldwell, Bob Helt, Beth Holden, Francesca McBride, and Kevin Schreier

  2. Personnel and their impact on Cleanroom Operations

    3. Jeanne Moldenhauer

  3. The Fundamentals of an Environmental Control Program

    4. William H. Miele

  4. Water Systems for Parenteral Facilities

    5. J. Manfredi

  5. Particulate Matter: Sub-Visible

    6. D. Scott Aldrich

  6. Endotoxin Testing

    7. Michael E. Dawson

  7. The Compendial Sterility Tests

    8. Scott VW Sutton

  8. Industrial Sterilization Technologies: Principles and Overview

    9. Anne F. Booth

  9. Steam Sterilization

    10. James Agalloco

  10. Gas, Vapor and Liquid Chemical Sterilization

    11. James Agalloco

  11. Dry Heat Depyrogenation and Sterilization

    12. Deborah Havlik and Kevin Trupp

  12. Radiation Sterilization
    Barry P. Fairand and Dusan Razem

  13. Filters and Filtration

    14. Maik W. Jornitz and Theodore H. Meltzer

  14. Processing of Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs)

    15. Donald A. Eisenhauer, Christine Martin, Roland Schmidt, and Steven G. Schultz

  15. Freeze Drying: Principles and Practice

          Steven L. Nail and Larry A. Gatlin

Biography

Sandeep Nema Ph.D. is Executive Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis. Since graduating in 1992 with his doctorate, Dr. Nema has been involved with the development of small molecule and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia), and has led the formulation of four launched products. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA), where he has chaired several meetings and focus groups. Dr. Nema holds an adjunct faculty appointment at the University of Tennessee.

John D. Ludwig Ph.D. is Vice President, Business Strategy, Operations, and Clinical Supply Planning, BioTherapeutics Pharmaceutical Sciences at Pfizer, and Site Director for the company’s St. Louis Laboratories. Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle, Inc., Pharmacia, Inc., and Pfizer. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute, where he has contributed to developing professional training courses and has regularly served as an instructor.

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