ABSTRACT
Microbiological quality assurance is a pre-emptive attempt to control microbial contamination by controlling all aspects of manufacturing. Changes in microbiological quality and standards for both the non-sterile pharmaceutical and the cosmetic industry have been by a process of evolution rather than by revolution. This chapter describes the environment as those factors, other than process equipment and people, which directly influence the microbiological quality of a finished product. These include the design of buildings and processes, the choice of construction materials and surface finishes, the provision of ancillary services such as lighting, ventilation, power and the exclusion of vermin. The type and frequency of microbiological monitoring of physical surfaces will depend on the susceptibility of the product to microbial contamination, the scale of manufacturing and the type of plant and process. Water systems are particularly susceptible to microbial contamination and must be designed to prevent microbes from proliferating and thence being introduced into products.
