Introduction

There is global recognition that pharmaceutical products must always be

• Effective for the therapeutic purposes for which they are prescribed

• Free from side effects that could make them unsafe to use

• Free of chemical, physical or microbiological contaminants that may adversely affect their efficaciousness and safety

The purpose of this chapter is to underpin the principles of contamination control in the manufacturing of sterile compounds, by addressing the ways in which pharmaceutical products may be contaminated by microorganisms, materials of microbiological origin and by visible nonviable physical particles. Chemical contamination and cross-contamination are not addressed in this chapter.

Microbiological contamination is not necessarily a problem per se. We inhale microbiologically contaminated air when we breathe, we eat contaminated food when we eat, we touch microbiologically contaminated surfaces everywhere. Microbiological contamination is only a problem when it results in unwanted effects caused by contaminated substances, and/or to the user of contaminated substances.

For both sterile and nonsterile pharmaceutical products, the severity of the effects of microbiological contamination is very much a function of the nature of the contaminated product, its intended use, and the nature and numbers of contaminants. At one end of the spectrum microbial contamination of injectable products may lead to death of the patient; at the other end patients may refuse to begin or complete a course of oral medication because of aromas, off-flavors or discolorations of microbiological origin.

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