Cleanrooms have evolved since 1988 because of the advances in science and technology. These innovations have benefitted consumers worldwide. New products, medical advancements, space exploration, travel, computers, and communications all have one major common denominator—better living through cleanroom technology.
In 2009, ISO/TC 209 work began under a new scope that would specify the minimum requirements for classification, design, and operations of nanotechnology facilities as they differ from cleanrooms described in the existing other ISO/TC 209 documents. A committee draft was published in 2012 and the working group is anticipating the publication of the first document, Classification of Air Cleanliness by Nanoscale Particle Concentration as a DIS (Draft International Standard) in early 2013.
Cleanroom costs for design and construction have greatly increased over the past 25 years. Materials of construction have improved and designers are more aware of the need for surfaces that can be cleaned and withstand aggressive disinfectants. However, degradation and the aging process are major concerns of the cleanroom user community. The internal surfaces of the cleanrooms and the HVAC system have become a major issue in older facilities. Ductwork wear and damage, surface finishes, electrical systems, computer systems are some of the areas that are affected by sporicidal agents that are used routinely in the sanitization process.
Environmental monitoring limits have changed—many regulators have lowered the limit standards. Some of today's cleanrooms were designed when the limits for air viable and surfaces were much higher. These changes to standards have resulted in additional cleaning (drowning) of the facility with disinfectants and sporicidal agents.
The cost of operations (i.e., utilities, supplies, salaries, support staff, security) has increased dramatically over the past 25 years. Today, companies must take into consideration the process, product, regulatory or customer requirements, risk, and quality requirements when designing a facility. The focus should be on "clean air" over the product and not create a "clean the world" facility. Designs are changing to include closed systems, separative devices, robotics, continuous monitoring, controls, and an understanding of contamination control. The final cleanroom layout and design should support the product and process.