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

chapter 2|9 pages

Characteristics of sterile dosage forms

chapter 3|9 pages

Types of sterile dosage forms

chapter 4|19 pages

Sterile product packaging systems

chapter 5|10 pages

Overview of product development

chapter 7|24 pages

Sterile products packaging chemistry

chapter 8|19 pages

Formulation and stability of solutions

chapter 9|23 pages

Dispersed systems

chapter 10|31 pages

Formulation of freeze-dried powders

chapter 12|14 pages

Overview of sterile product manufacturing

chapter 13|17 pages

Contamination control

chapter 14|10 pages

Sterile manufacturing facilities

chapter 18|11 pages

Sterile filtration

chapter 20|19 pages

Freeze-dry (lyophilization) processing

chapter 21|15 pages

Aseptic processing

chapter 25|10 pages

Good manufacturing practice

chapter 26|18 pages

Quality assurance and control

chapter 27|15 pages

Microorganisms and sterility testing

chapter 28|19 pages

Pyrogens and pyrogen/endotoxin testing

chapter 29|21 pages

Particles and particulate matter testing

chapter 30|18 pages

Sterile product-package integrity testing

chapter 31|8 pages

Administration of injectable drug products