Microbiology

van Doorne, Hans; Roesti, David; Staerk, Alexandra

Microbial contamination of pharmaceutical preparations may cause health hazard to the patient (e.g. infection, pyrogenic or allergic reaction), altered therapeutic activity of the product, or other decrease in quality (turbidity, loss of consistency, altered pH). This chapter provides a general introduction on pharmaceutical microbiology by focusing on the essential properties of micro-organisms. First of all the basic characteristics of life and the types of biological contaminants and potentially infectious agents of pharmaceutical products will be discussed: viz. prions, viruses, mollicutes, bacteria, fungi, and endotoxins. In the next section factors affecting survival and growth of micro-organisms are discussed. In addition to well-known factors such as time, temperature, and chemical and physical characteristics of the environment, attention will be paid to biofilm formation. Primary microbiological contamination is prevented by implementing an adequate microbiological quality control and quality assurance program and by following cGMPs during production. Microbiological quality control of pharmaceutical preparations and monitoring of production areas depend on the detection and quantification of micro-organisms. The classical, growth based, methods and some of the commercially available alternative methods are discussed. Understanding essential microbiological concepts is necessary in designing both microbiologically stable pharmaceutical products and ensuring an effective quality control and monitoring program within the manufacturing or preparation facility.