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.
STANDARDS
View the 1988 article, "Clean Room Management," by Anne Marie Dixon, at BioPharmInternational.com/Retrospectives.
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In 1992, at the instigation of the Institute of Environmental Sciences and Technology, the American National Standards Institute
(ANSI) petitioned the International Organization for Standardization (ISO) to create the Cleanrooms and Associated Controlled
Environments technical committee, formally established in May 1993. The mission of this committee was to develop an international
standard for cleanrooms and associated controlled environments encompassing standardization of equipment, facilities, and
operational methods. In accordance with ISO procedures, the work would be performed in "working groups." On November 29,
2001, ISO 14644-1 and 14644-2, officially replaced US Federal Standard 209 Airborne Particulate Cleanliness Classes in Cleanrooms
and Clean Zones. This change was necessary because until the formation of TC 209, each country had its own standard, which
differed from Federal Standard 209. The difference was confusing for companies with multiple plants worldwide. Federal Standard
209 also had limitations on particle classifications and size ranges. ISO/TC 209 pulled together the best of all of the existing
standards into one set of standards that could be applied to all cleanrooms, irrespective of product or process.
The ISO/TC 209 working groups addressed additional areas of interest beyond Federal Standard 209, such as Test methods
(ISO 14644-3), Design, Start-up and Construction (ISO 14644-4), Operations (ISO 14644-5), Separative Devices (ISO 14644-7),
Bio-contamination (ISO 14698-1,2), Classification of Air Cleanliness by Chemical Concentration (ISO 14644-8), and Classification
of Surface Particle Cleanliness (ISO 14644-9).
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.
OPERATIONS
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.
