The Effect of Cleanroom Design and Manufacturing Systems on the Microbiological Contamination of Aseptically Filled Products

Although cleanroom technology is employed in both the microelectronics and the pharmaceutical industry, the objectives of the two industries are different. The microelectronics industry is concerned about very small particles (i.e. < 0.3μm) in the manufacturing environment and often spends large amounts of money to control pariculate matter in the environment. The pharmaceutical industry, on the other hand, directs its efforts toward minimizing the risk of microbiological contamination. While the cleanroom extremes employed by the microelectronics industry certainly would not harm the quality of pharmaceutical products, they may not be the most cost-effective methods to minimize microbiological contamination. This paper explores various types of manufacturing constraints that can be employed to improve the sterility assurance of aseptically manufactured products.