Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality, 1st Edition (Hardback) book cover

Sterile Drug Products

Formulation, Packaging, Manufacturing and Quality, 1st Edition

By Michael J. Akers

CRC Press

516 pages | 100 B/W Illus.

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Hardback: 9780849339936
pub: 2010-08-20
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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common.

This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology:

  • Product development, including formulation, packaging, and process development.
  • Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control.
  • Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form
  • Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Table of Contents

Introduction, scope, and history of sterile products

Characteristics of sterile dosage forms

Types of sterile dosage forms

Sterile product packaging systems

Overview of product development

Formulation components (solvents and solutes)

Sterile products packaging chemistry

Formulation and stability of solutions

Dispersed systems

Formulation of freeze-dried powders

Overcoming formulation problems and some case studies

Overview of sterile product manufacturing

Contamination control

Sterile manufacturing facilities

Water and air quality in sterile manufacturing facilities

Personnel requirements for sterile manufacturing

Sterilization methods in sterile product manufacturing

Sterile filtration

Sterile product filling, stoppering, and sealing

Freeze-dry (lyophilization) processing

Aseptic processing

Inspection, labeling, and secondary packaging

Barrier and other advanced technologies in aseptic processing

Stability, storage, and distribution of sterile drug products

Good manufacturing practice

Quality assurance and control

Microorganisms and sterility testing

Pyrogens and pyrogen/endotoxin testing

Particles and particulate matter testing

Sterile product-package integrity testing

Administration of injectable drug products

Clinical hazards of injectable drug administration

Biopharmaceutical considerations with injectable drug delivery

About the Author

Michael J. Akers Ph.D. is Senior Director of Pharmaceutical Research and Development at Baxter 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, University of Tennessee, 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, 2002.

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General