thus providing improved guidance to field certifica-
Stillo echoes Windley’s excitement about the
evolution of the filtration industry by expressing his
belief that, “One of the biggest trends in the field is a
growing interest and adoption of a Life-Cycle-Cost
(LLC) approach by end users.” Stillo adds, “This
approach does not select filtration solutions based on
initial filtration solution cost but on the cost over the
life of a filtration solution. Therefore, the solution that
yields the best balance between initial cost, lifetime
loading performance, and associated disposal and
change-out costs is the winner.”
IEST-RP-CC001.6: HEPA and ULPA Filters describes
11 levels of filter performance and five grades of construction for filters suitable for use in clean air devices
and cleanrooms that fall within the scope of ISO 14644
and in systems requiring filter efficiency of 99.97 percent or higher for submicrometer (µm) particles.
IEST-RP-CC002.4: Unidirectional-Flow, Clean-Air
Devices outlines procedures for evaluating performance for classification of air cleanliness in accordance with ISO 14644-1.
IEST-RP-CC007.3: Testing ULPA Filters provides
guidelines and test criteria for determining the efficiency of ULPA and super ULPA filters in the factory
using particle counters.
IEST-RP-CC021.4: Testing HEPA and ULPA Filter
Media now includes photometric methodologies
in addition to particle count procedures for testing
physical and filtration properties of HEPA and ULPA
For ease of use, IEST-RP-CC034.4: HEPA and
ULPA Filter Leak Tests has separated the procedures
for production and in-situ testing into individual sections. The Recommended Practice provides methods
for leak-testing filters in the factory, at the job site, and
after installation in cleanrooms and clean-air devices.
Gordon Ely is IEST Technical Vice President
(Contamination Control), and the Manager of Regulatory
Affairs for MiMedx Group Inc. He is the Chair of IEST
Working Groups CC020 and CC025 and participates in
various working groups within ISO Technical Committees
(TC) 198 and 209. Gordon has worked in the pharmaceutical, medical device, and biologics industries for more
than 25 years. He is a certified Specialist Microbiologist
(SM) in Consumer and Industrial Microbiology and a
Registered Microbiologist. www.iest.org
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