10 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m
Cleanroom Monitoring
A
lthough classified environments are used even more exten-
sively in microelectronics, defense, and other high technology
enterprises, they are crucial to the manufacture of drugs, bio-
logics, and medical devices. International standards governing
cleanroom design and certification are not industry specific because their
implementation cuts across a broad swath of modern industries.
The first cleanrooms were built more than 70 years ago, and, for many
years, US Federal Standards 209 (FS2009), first published in 1963 (1), was
used to confirm their suitability. The methods and practices that evolved
from this initial effort are still widely used today.
Since that time, however, the principles of cleanroom design, construc-
tion, commissioning, and operation have matured. In 1999, a new global
standard, International Organization for Standardization (ISO) 14644
– Cleanrooms and associated controlled environments, replaced FS 209E
while retaining its original scope (2).
Two different activities, classification and monitoring, are crucial to un-
derstanding cleanroom standards and their utilization. These two activities
are broadly defined as follows:
• Classification—"[a] method of assessing the level of cleanliness
against a specification for a cleanroom or clean zone ... Levels should
be expressed in terms of an ISO Class, which represents maximum
allowable concentrations of particles in a unit volume of air"(2).
• Monitoring—"Defined, documented program which describes the
routine particulate and microbiological monitoring of processing and
manufacturing areas"(3).
Classification relates to particles, while monitoring may include both vi-
able and non-viable considerations. It intentionally avoids any consideration
of internally generated contamination, because that is outside the control of
the designer, builder, and classification contractor. The numbers of sample
locations, their selection, sampling equipment, and other specifications are
Distinguishing Between Cleanroom
Classification and Monitoring
A one-size-fits-all approach
to monitoring practices and
results is never appropriate,
given the diversity of practice
within the pharmaceutical
industry.
James Agalloco is principal
of Agalloco & Associates
(jagalloco@aol.com); Russell
Madsen is principal of The
Williamsburg Group (madsen@
thewilliamsburggroup.
com); and James Akers is
president of Akers, Kennedy &
Associates (akanckc@aol.com).
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James Agalloco, Russell Madsen, and James Akers
