History of Cleanrooms
History of Cleanrooms
History of Cleanrooms
This article was published in ASHRAE Journal, November 2019. Copyright 2019 ASHRAE. Posted at www.ashrae.org. This article may not be copied and/or distributed
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History of Cleanrooms
BY PHILIP NAUGHTON, MEMBER ASHRAE
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first production cleanroom.5 The mechanical ventilation. Another Figure 1 1936 Operating room showing UV lamps.
Western Electric room was designed important step in the field of air- Air inlet in the upper left.7
using 99.95% filters (see sidebar, borne infections was the use of
History of HEPA Filters, Page 42) and ultraviolet lighting in combination
positive pressurization. Others have with mechanical ventilation. Deryl
claimed the Olmsted Air Force Base Hart found that ultraviolet light
in Pennsylvania or the U.S. Navy’s would reduce the airborne bacteria
North Island Naval Air Station in in the operating room.7 While the
San Diego were the home of the first use of UV lighting was not directly
installations.6 part of the ventilation system, it
was integrated with the ventilation
Convergence of Ideas system to ensure adequate mixing
While advances in contamination of the air. An operating room at the sufficient volume to produce 480
control were occurring in manufac- Hospital for Sick Children in Toronto air changes per hour. The results
turing operations during the 20th combining air-conditioning ultra- indicated significant reduction in
century, the medical profession was violet lamps was constructed in 1936 airborne contamination.7
also experimenting with new con- (Figure 1). The design allowed testing Other studies, guides and regula-
tamination control methods. the efficacy of air changes and UV tions covered ventilation and its
Much research had been con- lights in removing bacteria from the effect on disease transmission, fever
ducted in the first half of the space. Air supply was slow enough therapy, patient comfort and draft
20th century on the benefits of to avoid a feeling of draft but was of perception, CO2 concentrations,
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ASHRAE RESEARCH table grouped by cleanliness class difference. Principal Investigator: Wei Sun,
P.E.; Keith B. Flyzik; John Mitchell; Aashish Watave; Publish Date: October 2011
ASHRAE has also funded several research projects related to
cleanrooms over the years. RP-1431 Analysis of Transient Characteristics, Effectiveness, and
Optimization of Cleanroom Airlocks
RP-202 Ventilation Requirements in Operating Rooms
A cleanroom airlock is a transitional space that has two doors in series to
Hospital operating rooms must meet one of the most complex set of control re-
separate cleanroom and corridor which often have different air cleanliness and pres-
quirements of any indoor environment, if acceptable performance is to be achieved.
sures. An airlock performs as a particle, microbial or chemical fume contaminant
The overall objective of this research project was to identify and demonstrate control
barrier by minimizing contaminated air to flow into a protective area. To study the
strategies that could reduce energy requirements while not producing deleterious performance and transient nature of airlock, especially when a door is in motion-
effects on the environmental quality within the operating room. during opening and closing, a new terminology called Contamination Ratio (CR) was
The objective was achieved through an extensive literature search in which more mathematically defined which can be used to quantify a relative contamination level
than 1,400 citations were referenced, through the development of mathematical and from contaminated area into protective area across a barrier such as a single door
biophysical models, and through analysis of data obtained in two existing operating or an airlock. The research has also analyzed the scenarios between the “walk-in”
rooms with different system performance characteristics. Principal Investigator: and “walk-out” by people, and between the “push-door-in” and “pull-door–out,”
Woods, J.E., Iowa State University; Publish Date: January 1984 in terms of particle transmissions. A recommendation table of airlock application
has been also included in the report. Principal Investigator: Wei Sun, P.E.; Keith B.
RP-652 Optimum Airflow Velocity in Cleanrooms Flyzik; John Mitchell; Aashish Watave; Publish Date: October 2011
Findings from the research show that nominal airflow velocities as low as 60
fpm (0.3 m/s) are possible without a loss of cleanliness for specific work sites in RP-1399 Survey of Particle Production Rates from Process Activities in
the cleanroom. Cross contamination between adjacent workspace on the cleanroom Pharmaceutical and Biological Cleanrooms
bench was found not to be a significant problem. However, the room airflow rate The aim of this research project was to understand particle sizes and the
required depends on the room configuration as well as the location and strength rates of particle generation for representative processes in pharmaceutical and
of the source of contamination. Therefore, a nominal velocity of 60 fpm (0.3 m/s) biotechnological cleanrooms. This was achieved via field measurements and
may not be appropriate for all cleanrooms. Principal Investigator: Iowa State data collection in several pharmaceutical and biotechnology cleanrooms. Field
University; Publish Date: October 1994 measurements were performed using certified and calibrated particle counters
and airflow meters. The airflow data, particle data, and cleanroom air conditions
RP-1344 Cleanroom Pressurization Strategy Update—Quantification and were recorded for both ‘operational’ and ‘at rest’ conditions to deduce the particle
Validation of Minimum Pressure Differentials for Basic Configurations generation rate. Principal Investigator: Li Song; Oluwaseyi T. Ogunsola; Junke
and Applications Wang; Publish Date: June 2018
The research illustrated that room air leakage rate is a critical variable in deter-
mining the room “flow offset” value. Particle migration from a less-clean room into Ongoing Research
a cleanroom is not only driven by pressure differential, but also by particle concen- RP-1604, Demand-Based Control for Cleanrooms, is examining this
tration differential in a form of mass diffusion. The recommendations included a concept and collecting qualitative data on the effectiveness of the use
“Minimum Pressure Differential (PD) Requirements Across Cleanroom Envelope” of demand controlled filtration.
humidity, etc. Anesthesia gas use in surgery was com- In 1946 Robert Bourdillon and Dr. Leonard Colebrook
monplace, such that air-conditioning engineers and showed that sepsis of burns and wounds could be caused
medical professionals were concerned with controlling by bacterial contamination from the air and that well-
the atmosphere in operating suites due to the explo- designed ventilation equipment could play a large part
sive nature of the anesthesia gases. One of the earliest in preventing this. Additional work on the design of
publications of suggested air change rates in hospitals surgical suites was conducted in the 1950s on plenum
was published in the 1938 ASHVE Guidebook: “Copious ventilation and the use of designed inlet and outlet room
ventilation, from 6 to 12 air changes per hour, is neces- conditions.10
sary to preclude accumulation of explosive mixtures and Disturbed by the large amount of septic cases and
to reduce the concentration of anesthetics to below the postoperative infections, hip-replacement surgeon John
physiologic threshold so that the surgeon and his per- Charnley began investigating new methods of operating
sonnel will not be affected.8,9 room ventilation. Building upon the work of Bourdillon
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90 fpm & Laminar Flow who said that the fans used in his cleanroom could pro-
One of the most enduring questions concerning clean- duce between 50 fpm and 200 fpm (0.3 m/s to 1.0 m/s).
room standards is “why 90 fpm?” FED-STD-209A, B, 50 fpm (0.3 m/s) could not remove particles fast enough
which were in effect for over 20 years, had specified 90 if more than one person was in the room, and above 100
fpm ±20 fpm (0.5 m/s ±0.1 m/s) in the facility design fpm (0.5 m/s) the noise from the fans became annoying.5
guidance. Numerous anecdotes and second- and third- This seems more in alignment with Whitfield’s explana-
hand stories speak about that the origins of the velocity tion in 1963. The most logical answer is a combination
used in Willis Whitfield’s laminar flow system. Some had of items, worker comfort (sound and draft) and recovery
speculated this was the velocity theoretically calculated rate.
to remove a particle dropped in front of the supply filter In addition to the origins of 90 fpm (0.5 m/s) and
in the first laminar flow room at Sandia Corporation. equally controversial was Whitfield’s decision to use the
Another opinion was that the only air supply fan avail- term laminar flow when describing his unidirectional
able to Willis Whitfield produced this air velocity. Another airflow in the ultra-cleanroom. It was known that from a
said that the 90 fpm (0.5 m/s) was the minimum velocity purely scientific basis, airflow in this room was not lami-
needed to overcome buoyancy effects of a hot surface in nar. During an interview in 2005, Willis responded to a
the workspace.5 question from Sandia Lab News: “Lab News then asked
90 fpm (0.5 m/s) is almost equal to 1 mph (0.4 m/s), and just what was ‘laminar’ about the so-called ‘laminar flow
velocities greater than 100 fpm (0.5 m/s) can produce a cleanroom’ — the usual term used to describe his group’s
sensation of draft for some people. Whitfield had said invention. ‘Nothing,’ said Willis, who described the word
“The real value of filtered laminar airflow is the high as a preexisting marketing term and a catchy name. ‘The
degree of cleanliness that it maintains at very low veloci- air is just unidirectional.’ ” 28 Mr. Whitfield has also said
ties, well below personnel discomfort levels. The 100 lin- he very carefully puts ‘laminar flow’ in quotation marks
eal fpm (0.5 m/s) air velocity utilized in these rooms was when outlining the innovation and refers instead to ‘uni-
well below the rate of 150 fpm to 200 fpm (0.8 m/s to 1.0 directional air flow.’ Whitfield traces the application of
m/s), which is generally considered to be the threshold of the name to his innovation to the meetings of the group
personnel discomfort.” 13 Others have quoted Whitfield, that devised Standard 209. 21
and Colebrook in 1946, and Blowers investigating why cleanrooms could cleaning the space. The problem
and Crew in the 1950s, Dr. Charnley not stay clean. The problem was that was particles generated within the
and air-conditioning engineer while previous cleanrooms could space stayed in the space unless they
James Howarth built one of the first achieve a desired level of cleanli- were removed by the cleaning staff.
unidirectional airflow rooms using ness, they did not remain clean Previous work was focused on clean-
sterile air supply and displacement without continuous cleaning by per- ing people, isolating the contami-
ventilation.11,4 sonnel. The problem was still that nation from people with improved
some of the best cleanrooms and clothing, continuous cleaning of
Beginnings of Modern Cleanrooms clean hoods would average no better work surfaces, disinfecting surfaces
The watershed event in the history than approximately 100,000 par- and materials and providing clean
of the cleanroom was the invention ticles of 0.5 micron and larger per filtered air to the space. Whitfield’s
of the first “laminar flow” or true cubic foot. The focus was on keeping team needed a method to keep pro-
unidirectional concept of ventila- contaminants out, not on removing viding clean air and to remove the
tion in 1960 – 1961 by physicist Willis any generated by the work or per- particles generated within the space.
Whitfield, Ph.D., at the Sandia sonnel inside the room.12 Whitfield and team’s approach to
Laboratories in Albuquerque, N.M., New products being manufac- the problem was to create a “radical
while working with the U.S. Atomic tured required continuous cleaning, design”—by comparison with a con-
Energy Commission (AEC).5 In and the generation of particles was ventional cleanroom. Conventional
1959 Whitfield and his team were exceeding the ability of the those cleanroom problems were grouped
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into three general categories:13,14 Figure 2 Willis Whitfield’s “laminar flow” cleanroom Figure 3 Willis Whitfield in prototype “laminar flow”
design.13 cleanroom. 13
•• Conventional cleanrooms did
not have a self-cleaning capability to
offset contamination brought into
the room by personnel and equip-
ment or not captured by the air
filtration system.
•• Airflow patterns in conven-
tional cleanrooms are generally not
uniform, nor are they directed in a
manner that carries particulate mat- the supply side—but how to remove
ter away from critical work areas. In the air from the space?
addition, they will not remove air- At first Whitfield’s team was going
borne contamination from the room to use a large number of return
as quickly as it is brought in. grilles located near the floor at the
•• Since all personnel in a conven- walls. The problem with this was
Figure 4 Willis Whitfield’s “knock-down” portable
tional cleanroom contribute heavily larger particles would still settle cleanroom.13
to room contamination, rigid per- to the floor. The concept of using a
sonnel controls were required. perforated floor was proposed and
Whitfield’s team focused on the a pilot test conducted. Having the
need for self-cleaning, examining air leave at the floor would allow for
the airflow volume and air patterns air movement to assist in the natu-
within the space. It appeared that ral settling of particles by gravity.
greater airflow would be a partial A prefilter was installed just below
solution. However, it was known the floor to capture the particles and
that when airflow was increased in a avoid their being reintroduced into
previous cleanroom design, the con- the space (Figure 2). Early concerns
tamination level rose. This is partly that the constantly moving air would times cleaner than clean work
due to agitation of settled particles, irritate workers in the space were hoods. Circulating large amounts of
and partly to the fact that particles allayed by the actual rate of move- air provided a “sweeping” function
blown off personnel and equipment ment. The air moved at about 1 mph over the working area. Whitfield
was dispersed into the air. The use (1.6 km/h), resulting in about 10 said “the room almost ‘cleans’
of air blasts was also evaluated, but changes of air per minute. itself.” 16 Whitfield gave his initial
the same problem of just moving the By the end of 1961 the team had paper on what was then called the
particles around the room persisted. constructed a “laminar flow” clean- “ultra-clean room” at the Institute of
Therefore, they wanted to avoid an room. The room was relatively small, Environmental Sciences meeting in
air blast from supply diffusers.15 only 6 ft × 10 ft (1.8 m × 3.0 m) with Chicago in 1962.13,17 (Figure 5).
Trying to avoid the air blast prob- a 7 ft (2.1 m) high ceiling (Figure 3). The success of the laminar flow
lem, the team initially considered a After testing the first version, a “por- cleanroom and clean bench quickly
design using single-pass unidirec- table” version was also built (Figure 4), spread to other agencies and con-
tional airflow using the ceiling as a and later a knock-down version was tractors supporting military prod-
large diffuser. This solution would built, allowing for disassembly of the ucts and space products. Even the
slow the air down and mitigate the room where all components could fit popular press jumped into anoint-
perceived air blast and particle through a 3 ft (0.9 m) wide door. ing Whitfield “Mr. Clean.” 18 Sandia
dispersion, avoid the perception of This cleanroom was 1,000 times was inundated with requests to
draft by the workers and provide a cleaner than the contemporary see the ultra-clean room.19 The
quieter environment. This solved cleanrooms of the time and 100 ability of laminar flow to reduce
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microbiological contamination was also Figure 5 Excerpt from Willis Whitfield Lab Notebook (left) and Patent Application.12,16
investigated, with Dr. Randy Lovelace, M.D.,
seeking to use a cleanroom during operating
procedures, and NASA was seeking propos-
als to have cleanrooms used in the space
program. RCA and General Motors Co. were
early adopters of the cleanroom, and the
invention revolutionized the pharmaceuticals
and microelectronics industries.17 By the end
of 1962 more than 20 companies had been
licensed to construct and build clean benches
and cleanrooms for various projects.
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did you define “uniform”? There was issued by the U.S. General Services included in the 209A,B documents.
a need to have repeatability and cost Administration (GSA) and assigned A major revision was undertaken
control when procuring cleanrooms the code FED-STD-209.19 During with 209C (1987), with the addi-
from various suppliers. 1964, use of “laminar flow” devices tion of two more cleanliness classes,
To help with procurement of its spread quickly with variants in both Class 1 and Class 10. 209C allowed
cleanrooms, in 1961 the U.S. Air vertical and horizontal cross flow interpretations of intermediate
Force issued Air Force Technical cleanrooms. The design was quickly class (e.g., Class 50), but not the
Order 00-25-203, Standard Functional being applied into industry, medi- extrapolation of particle concentra-
Criteria for The Design and Operation cine, NASA centers, the military, and tions outside a set range for each
of Clean Rooms. This is considered some use was noted in Europe. The cleanliness classification. The inclu-
the first widely accepted clean- AEC was the owner of the Whitfield’s sion of particle sizes down to 0.1 µm
room standard. TO 00-25-203 “Ultra-Clean Room” and freely was also added along with more
specified 4 cleanroom levels from allowed others to use the design. The defined testing, sampling require-
1 to 4.5 The Air Force was in the Western Electric Co. in Allentown, ments and statistical analysis. The
process of updating U.S. Air Force Pa., reported that it had installed term “laminar flow” was officially
Technical Order 00-25-203 when 900 “laminar flow clean benches” by replaced with unidirectional airflow
the announcement of Whitfield’s the end of 1964, and RCA completed and non-laminar flow replaced by
“laminar flow” cleanroom indi- a 20,000 ft2 (1859 m2) facility for nonunidirectional.
cated cleaner cleanrooms could be color CRT picture tubes.21,22 A minor revision of FED-STD-
achieved using Whitfield’s design. The increased reliance upon clean- 209C was issued in version 209D
There was much excitement from room standards for various applica- (1988), while the next major revision
government agencies and indus- tions warranted continued amend- was the last and final version 209E
tries seeking to publish their own ing and updating of cleanroom stan- (1992). FED-STD-209E introduced
cleanroom standards.20 By 1963, the dards. Many countries completely a metric equivalent for cleanroom
lack of a set of cleanroom standards adopted FED-STD-209, while others classes, changes in sampling for
was evident, and in April 1963 a made their own national version, determination of class, the addition
major cleanroom conference was similar to FED-STD-209. Some made of new cleanroom classifications (M
announced, to be hosted by Sandia minor changes to the classes to com- Classes) and conversion to SI units of
Laboratories in Albuquerque, New ply with the metric system. Federal measure.
Mexico. Standard 209, being used around While the final versions of FED-
A working group chaired by Mr. the world, was amended multiple STD-209E were being published,
J. Gordon King was formed, and times (Table 1). The 209, 209A, 209B a group of international con-
together they created the first (1973 and 1976 amended version) tamination control stakeholders
federal standard, titled Cleanroom identified only 4 cleanliness classes had already begun work on an
and Work Station Requirements, similar to TO 00-25-203. Particle international standard to replace
Controlled Environments. It was sizes specified down to 0.5 µm were all national standards. In 1992
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Standards ISO U.S.A. U.S.A. U.S.A. U.S.A. BRITAIN BS AUSTRALIA FRANCE GERMANY JAPAN EU ISO
STANDARD 209A,B 209C 209D 209E 5295 AS 1386 AFNOR X44101 VDI.2083 JACA GGMP STANDARD
Organization (ISO)
established Technical ISO Class 1 ISO Class 1
Committee ISO/ ISO Class 2 – 0 ISO Class 2
TC 209 with a goal ISO Class 3 1 1 M1.5 C 0.035 – 1 3 – ISO Class 3
of producing a har- ISO Class 4 10 10 M2.5 D 0.35 – 2 4 – ISO Class 4
monization of inter-
ISO Class 5 100 100 100 M3.5 E or F 3.5 4,000 3 5 A/B ISO Class 5
national standards.
ISO Class 6 1,000 1,000 M4.5 G or H 35 – 4 6 – ISO Class 6
ISO 14644 Parts 1
and 2 were issued ISO Class 7 10,000 10,000 10,000 M5.5 J 350 400,000 5 7 C ISO Class 7
in 1999, and several ISO Class 8 100,000 100,000 100,000 M6.5 K 3,500 4,000,000 6 D ISO Class 8
other sections have ISO Class 9 ISO Class 9
been issued since.
14644 introduced two cleaner classes and one less clean
TABLE 3 ISO 14644 cleanroom standards.
class (Table 2). ISO/TC 209 continues to meet and guide
updates and issuing of 14644 documents (Table 3). PART 1 Classification of air cleanliness by particle concentration
tries in the 1960s and 1970s, including NASA’s space pro- PART 4 Design, construction and start-up
gram, transistor and integrated circuit manufacturing, PART 5 O perations
pharmaceutical manufacturing and hospitals. Dr. Randy
PART 7 Separative devices (clean air hoods, gloveboxes, isolators and minienvi-
Lovelace and The Bataan Hospital in Albuquerque put ronments)
the first “laminar flow” surgical suite into operation dur- PART 8 C lassification of air cleanliness by chemical concentration (ACC)
ing 1966. Dr. E. O. Goodrich, M.D. (St. Vincent’s Hospital
PART 9 Classification of surface cleanliness by particle concentration
in Santa Fe, N.M.) began studies in using a “laminar
PART 10 Classification of surface cleanliness by chemical concentration
flow” operating table module, also in 1966. 1967 saw M.D.
Anderson’s chemotherapy treatment center begin experi- PART 12 C lassification of air cleanliness by nanoscale particle concentration
menting with cleanrooms. Over 300 “laminar flow” sys- PART 13 C leaning of surfaces to achieve defined levels of cleanliness in terms of
tems were being used in hospitals by 1972. Burn centers, particle and chemical classifications
joint replacement surgery and other operations needing PART 14 A ssessment of suitability for use of equipment by airborne particle
concentration
strict aseptic control were all starting to deploy laminar
flow technology. A study of airflow patterns and levels of PART 15 Assessment of suitability for use of equipment and materials by airborne
chemical concentration
airborne contamination at various critical sites in a simu-
PART 16 E nergy Efficiency in Cleanrooms and Clean Air Devices
lated operating room equipped with a horizontal unidi-
rectional airflow system was published in 1969.23 Medical PART 17 P article deposition rate applications
device manufacturers and even food packaging facilities
were also adapting cleanroom to their needs.21 200 µm, but by 1971 they were 10 µm and less than 1 µm
Whitfield’s development coincided with the introduc- by the early ‘80s. The rapid development of new and
tion of integrated circuits into electronics design and more complex integrated circuits required the semi-
manufacturing. Based on breakthroughs by Jack Kilby conductor industry to pioneer many new advances in
at Texas Instruments (1958), Robert Noyce and Jean cleanroom designs, including the multilevel vertical
Hoerni at Fairchild Semiconductor, and Kurt Lehovec unidirectional cleanroom capable of achieving Class 1
of Sprague Electric Company, the first functional semi- cleanroom conditions (Table 2).
conductor integrated circuit was introduced in 1960. The 1970s also saw the publication of key good manu-
Initially, feature sizes of these integrated devices were facturing practices (GMP) documents. GMPs for drugs
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(21 CFR Parts 210 and 211) and medi- Figure 6 Semiconductor Multilevel Cleanroom.26 Courtesy M+W Group
cal devices (21 CFR 820) were made
final in 1978. They were intended to
help ensure the safety and efficacy of
all products and referenced clean-
rooms and cleanroom standard FED-
STD-209A and later amendments.
GMP requirements for devices were
intended to govern the methods used
in and the facilities and controls used
for the design, manufacture, packag-
ing, labeling, storage, installation,
and servicing of all finished medical
devices intended for human use.24,25
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for engineers on the application of clean spaces.† The Guide for Cleanrooms: Fundamentals, Systems, and Performance
1966 and 1971 Handbooks combined “clean spaces” was published in 2018. The design guide covers the latest
with computer rooms, while 1974 saw the first solitary information on fundamentals of contamination control,
chapter covering “clean spaces.” A terminology section cleanroom air management, particle theory, application
was added in 1966. Clean space applications contin- of CFD and select industry applications.26
ued to warrant special attention as Task Group in TC
9.2 Industrial Air Conditioning until its elevation to a Conclusion
Technical Committee TC 9.11 in 1996. The application of cleanrooms has become a common
ASHRAE guidebooks and handbooks have followed method of controlling contamination and improving
advances in cleanroom standards referencing FED- the environment for people, equipment and materials.
STD-209 in the 1966 handbook and the ISO Standards ASHRAE has been providing air-conditioning engineers
soon after their publication in the early 2000s. The guidance on cleanrooms for over 50 years and will con-
Handbook added a section on the use of computational tinue into the future.
fluid dynamics (CFD) in 1995, providing updates on CFD
application and benefits ever since. Energy savings in References
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invented by Sandia physicist still used 50 years later.” Retrieved Sandia Lab News, p. 7 – 9.
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