Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality

by Michael,J,Akers; BAXTER BIOPHA

• ISBN13: 9780849339936
• ISBN10: 0849339936
• Edition: 1st
• Format: Hardcover
• Copyright: 2010-08-20
• Publisher: CRC Press

Summary

Supplying the latest research on the formulation, manufacture, quality control, and regulation of pharmaceuticals, biopharmaceuticals, and related products, this reference contains up-to-the-minute chapters on contamination control, facilities management, inspection, distribution, GMP, sterility and stability testing, and aseptic environments.

Author Biography

Michael J. Akers Ph.D. is Senior Director of Pharmaceutical Research and Development at Baxter BioPharma Solutions and leads the Baxter Lyophilization Center of Excellence in Bloomington, Indiana. Dr. Akers received his B.A. degree from Wabash College and Ph.D. degree in Pharmaceutics from the University of Iowa College of Pharmacy, and has previously been employed at Searle Laboratories, Alcon Laboratories, the University of Tennessee College of Pharmacy, and Eli Lilly and Company. Dr. Akers is active in the Parenteral Drug Association and is a Fellow of the American Association of Pharmaceutical Scientists. He is Editor-in-Chief of Pharmaceutical Development and Technology, and author or editor of six books, including Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Packaging Integrity Testing, Third Edition, Informa Healthcare, 2002.

Table of Contents

Preface	p. v
Acknowledgments	p. vii
Introduction, scope, and history of sterile products	p. 1
Characteristics of sterile dosage forms	p. 11
Types of sterile dosage forms	p. 20
Sterile product packaging systems	p. 29
Overview of product development	p. 48
Formulation components (solvents and solutes)	p. 58
Sterile products packaging chemistry	p. 72
Formulation and stability of solutions	p. 96
Dispersed systems	p. 115
Formulation of freeze-dried powders	p. 138
Overcoming formulation problems and some case studies	p. 169
Overview of sterile product manufacturing	p. 180
Contamination control	p. 194
Sterile manufacturing facilities	p. 211
Water and air quality in sterile manufacturing facilities	p. 221
Personnel requirements for sterile manufacturing	p. 236
Sterilization methods in sterile product manufacturing	p. 247
Sterile filtration	p. 267
Sterile product filling, stoppering, and sealing	p. 278
Freeze-dry (lyophilization) processing	p. 294
Aseptic processing	p. 313
Inspection, labeling, and secondary packaging	p. 328
Barrier and other advanced technologies in aseptic processing	p. 346
Stability, storage, and distribution of sterile drug products	p. 362
Good manufacturing practice	p. 372
Quality assurance and control	p. 382
Microorganisms and sterility testing	p. 400
Pyrogens and pyrogen/endotoxin testing	p. 415
Particles and particulate matter testing	p. 434
Sterile product-package integrity testing	p. 455
Administration of injectable drug products	p. 473
Clinical hazards of injectable drug administration	p. 481
Biopharmaceutical considerations with injectable drug delivery	p. 486
Index	p. 495
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