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

© 2004 by CRC Press LLC 53

a deeper understanding of the nature of microbiological contamination in drug production.

The particular purpose of sterile drug manufacture by aseptic processing is the avoidance of microbiological contamination. Proper clean-room design, engineering and operation make the probability of finding nonsterile units in populations of sterile dosage forms often immeasurably low.

Some contamination of aseptic filling lines and their surroundings is, however, usually unavoidable. The probability of finding microorganisms contaminating aseptic filling rooms is higher than that of finding contaminated dosage forms. The probability of finding microorganisms contaminating support areas and change rooms is even higher.

The purpose of media fills and related operations, such as environmental monitoring, is to obtain an index of the typical levels of microbiological contamination occurring in aseptic manufacturing and their support areas. These indices of typicality are used as comparators to identify unusual events, which may indicate occasional or persistent lapses in contamination control. The levels of contamination tolerance vary from situation to situation.

Here we help unravel any mystique surrounding microbiological contamination, for readers at all levels with an interest in the pharmaceutical industry.

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