ABSTRACT

This chapter discusses the design components of various types of clean-room environments found in a sterile manufacturing area. One of the most important components of pharmaceutical manufacturing is the environment under which the production is carried out. The design and layout of a manufacturing facility is critical to preventing cross-contamination, exposure to workers, and generally making a safe product for human or animal consumption. These considerations are more important in the processing of sterile products where contamination of any type can render the product unsuitable. These products are thus processed in clean rooms. Clean rooms are categorized by their cleanliness levels and the type of airborne material that is controlled; the latter definition is more pertinent to design of aseptic areas where the goal is to reduce the quantity of living organisms or their by-products, these are called bio-clean rooms.