ABSTRACT
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
1 INTRODUCTION
Along with many other publications in good manufacturing practice (GMP) our purpose is to guide readers to a starting point, from which they can then progress to
a deeper understanding of the nature of microbiological contamination in drug production.
