Volume 2 provides:
- Chapters on aseptic facility design, environmental monitoring, and cleanroom operations.
- A comprehensive chapter on pharmaceutical water systems.
- A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing.
- A detailed chapter on processing of parenteral drug products (SVPs and LVPs).
- Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat.
- An in-depth chapter on lyophilization.
1. Aseptic Manufacturing Facility Design Mark Caldwell, Bob Helt, Beth
Holden, Francesca McBride and Kevin Schreier
2. Personnel and their Impact on Cleanroom Operations - Jeanne Moldenhauer
3. The Fundamentals of an Environmental Control Program - William H. Miele
4. Water Systems for Parenteral Facilities - J. Manfredi
5. Particulate Matter: Sub-Visible - D. Scott Aldrich
6. Endotoxin Testing - Michael E. Dawson
7. The Compendial Sterility Tests - Scott VW Sutton
8. Industrial Sterilization Technologies: Principles and Overview - Anne F. Booth
9. Steam Sterilization - James Agalloco
10. Gas, Vapor and Liquid Chemical Sterilization - James Agalloco
11. Dry Heat Depyrogenation and Sterilization - Deborah Havlik and Kevin Trupp
12. Radiation Sterilization - Barry P. Fairand & Dusan Razem
13. Filters and Filtration - Maik W. Jornitz and Theodore H. Meltzer
14. Processing of Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs) - Donald A. Eisenhauer, Christine Martin, Roland Schmidt, Steven G. Schultz
15. Freeze Drying: Principles and Practice - Steven L. Nail and Larry A. Gatlin
"The authors have thoroughly covered parenteral dosage form development. . .All of the first edition chapters included in this volume. . .have been updated. New chapters added. . .cover the changes in the subject matter. . .The book is very well written for scientists and engineers in the pharmaceutical industry and academia. There is a very good balance between the theoretical considerations and practical aspects of parenteral dosage form development. Individual chapters are well defined and very informative on specific issues including. . .regulatory standards. . .[an] excellent reference. . .for undergraduate and graduate pharmacy students. . .pharmacy school libraries and to pharmaceutical and biotechnology industry. It would also make an excellent training tool refresher course. . .for R&D scientists working in the parenteral dosage form development area. Inclusion of topics such as freeze drying, clean-in-place steam-in-place, designing of biopharmaceutical facilities, and ophthalmic formulations in thisedition strengthens the basic structure of this book and provides the reader with an excellent overview of parenteral dosage form development. "---American Journal of Pharmaceutical Education (Review of 2nd edn - Volume 2)
Sandeep is Executive Director, Pharmaceutical R&D, Global Biologics in St. Louis where he is responsible for Formulation Development of biotherapeutics with a focus on vaccines and oligonucleotides. In this role he manages projects from discovery support, formulation development, scale-up, and validation through regulatory filings.
Sandeep is a Certified Regulatory Affairs Professional. He is active in AAPS and PDA where he has served as Chairman, Arden House Conference on “Parenteral Products: Integrating Science, Innovation and Patient Needs” (2002); Co-Chair, AAPS/FDA/USP workshop on ‘Future Direction in Aseptic Processing’, (2003); and past Chair of Sterile Product Focus group. He is also an adjunct faculty at University of Tennessee. Sandeep was a Steering Committee Member for the Handbook of Pharmaceutical Excipients.
Sandeep received his PhD in 1992 and since then 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). He has been lead formulator for four launched products.
John began his career with Burroughs Wellcome Co. in 1989 as a pharmaceutical formulator and worked on a variety of dosage forms including liquid and lyophilized parenterals, topical creams and ointments, and oral liquids. He joined Searle, Inc. in Skokie, IL in 1995 responsible for parenteral product formulation and process development, clinical manufacturing, technology transfer/validation, and the R&D microbiology function. In 2001 he transferred to Chesterfield, MO as Site Leader for the Bioprocess and Formulation Technology organization (Pharmacia, Inc.). Following the Pfizer acquisition in 2003, John led the combined Pharmaceutical and Analytical R&D line for Pfizer Global Biologics and from 2007-2009 the Analytical R&D organization. He currently leads the Business Strategy, Operations, and Clinical Supply Planning function, and serves as Site Director for Pfizer St. Louis Laboratories.
John is active in the American Association of Pharmaceutical Scientists and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to developing three professional training courses and serves regularly as a course instructor for PDA.
John's research interests include parenteral container/closure integrity evaluation and protein stabilization and processing.
Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis. He lives in Wildwood, MO with his wife Sue and their three children.