Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition: Volume 2: Facility Design, Sterilisation and Processing

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