14 BioPharm International eBook March 2021 www.biopharminternational.com
A Real-World Approach to Evaluating
Cleanroom Garments
Traditional methods fail to test for dynamic conditions in the cleanroom.
A holistic testing approach considers particulate shedding and heat
load during processing, as well as the impact of
laundering on the garment life cycle.
C
ontrolling the contamination gener-
ated by human operators and their
clothing during manufacturing and
other activities is a major concern for
cleanrooms and controlled environ-
ments. People disperse large numbers of particles (i.e.,
skin fragments, bacteria, and hair), with the total
number varying over time and depending on the
individual operator.
Cleanroom garments must be designed to protect
the environment and the process by containing any
particles shed by the operator without becoming a
source of further contamination. In addition to man-
aging the particulate load, cleanroom gowns may also
need to contain any microbes shed by operators that
could pose a risk to the product and process.
Cleanroom managers are charged with selecting the
best cleanroom garments and related systems for their
specific environments. This article will present a new
testing approach designed to assess conditions during
operations. It is based on the following important
considerations, which are not always included in the
typical cleanroom garment selection process:
mantinov
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Stock.adobe.com
Anne Marie Dixon-Heathman, annemarie@cleanroommanagement.com, is principal
of Cleanroom Management Associates, Inc.
ANNE MARIE DIXON-HEATHMAN
Regulatory Sourcebook Operations
