Contradictory demands of cleanroom manufacturing

Domestic and international regulations, customer demand, competition, and the imperatives of quality assurance are all pressures that are pushing medical device manufacturers to adopt higher standards in their cleanroom manufacturing practices. At the same time, these manufacturers are feeling countervailing pressures from the public, medical practitioners, hospitals, insurance companies, and competitors to contain costs. These two contradictory sets of pressures indicate the state of mind of many medical device manufacturers today as they consider their cleanroom options. This article presents a brief overview of how several of these manufacturers view their clean-rooms, why and how they use them, and some of the main issues that concern them, followed by some more general observations from various consultants, designers, and vendors.