INTRODUCTION

Monitoring of in-process bioburden of pharmaceutical components and products is an essential element of the overall contamination-control program for appropriate sterilization process control. Bioburden monitoring should be designed for the recovery of a broad range of microorganisms that are likely to be present in the material being processed. Sterilization processes are implemented in order to eliminate bioburden in materials and the products, ensuring both adequate process control and end-user safety.