Contents

Preface vii

Publisher's Note xi

Chapter 1 Effects and Causes of Contamination in Sterile Manufacturing . . 1

Nigel Halls

Chapter 2 Microbiological Environmental Monitoring 23

Nigel Halls

Chapter 3 Media Fills and Their Applications 53

Nigel Halls

Chapter 4 Contamination of Aqueous-Based Nonsterile Pharmaceuticals. . . 85

Nigel Halls

Chapter 5 Bioburden Determinations 115

Norman Hodges

Chapter 6 Materials of Construction and Finishes for Safe Pharmaceutical

Manufacturing 137

Dennis Fortune

Chapter 7 Rapid Microbiological Methods Explained 157

Stewart Green and Christopher Randell

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