Nigel Halls

CONTENTS

1 Introduction 53

2 Media Fills: Purposes 54

3 Media Fills: Placebos 56

4 Media Fills: Simulation of Processes 57

4.1 Simulation of Solid-Dosage Form Aseptic Filling

Processes 58

4.2 Simulation of Aqueous-Liquid Aseptic Filling Processes 61

4.3 Simulation of Processes Involving Aseptic Bulk Compounding Before Filling 64

4.4 Simulation of Lyophilization Processes 64

5 Media Fills: Microbiological Considerations and Controls 66

5.1 Growth Support and Sterility Controls 66

5.2 Foul-Up Controls 69

5.3 Environmental Monitoring and Media Fill Observation 70

6 Media Fills: Incubation 70

7 Media Fills: Applications 72

7.1 Media Fills in Validation of Aseptic Processes 73

7.2 Periodic Media Fills in Routine Operation 79

References 83

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