Nigel Halls

CONTENTS

Introduction 2

1 Effects 2

1.1 Introduction 2

1.2 Contamination of Sterile Products 4

1.3 Parenteral Products 4

1.4 Viability 5

1.5 Pyrogens 6

1.6 Endotoxins 6

1.7 Particulate Matter 7

1.8 Ophthalmic Products 7

1.9 The U.S. Requirement for Sterility in Aqueous Inhalations 8

2 Causes of Contamination 8

2.1 Introduction 8

2.2 Contamination from Air 9

2.3 Clean Rooms Defined 9

2.4 Contamination from Water 10

2.5 Contamination from Materials 11

2.6 Contamination from People 11

2.7 Modeling Contamination 13

2.8 The Plateau Effect 13

2.9 Contamination and Loss of Sterility 14

2.10 Mathematical Models 16

2.11 Whyte's Analyses 17

References 21

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