by
Walter Morris, PDA | Jan 30, 2017
Expansion Includes Additional Classrooms, Larger Gowning Room, and Modular Cleanroom
PDA has completed a six-month expansion
of its Training and Research Institute (TRI)
in Bethesda. The expansion will permit
PDA Education to increase its capacity for
hands-on aseptic processing and lecture-based
training at TRI.
The centerpiece of the buildout is a new
400 ft2 ISO Class 8 cleanroom that will
house an isolator filling system. The cleanroom
is enclosed by modular walls from
Servicor and the air is processed with a
HEPA air system.
“The hands-on aseptic processing instruction
offered in an industrial setting at the
Training and Research Institute is a critical
component of PDA’s educational program,”
said Craig Elliott, PDA Vice President
of Education. “PDA Education’s ‘Aseptic
Processing Training Program’ provides an
in-depth experience with the technologies associated with the manufacture of aseptically
produced products, and now we have
the capacity to train even more professionals
each year.”
PDA’s aseptic processing program is
highly valued and effective. “We’ve seen
a dramatic increase in training demand
recently, particularly from US regulators.
Last year PDA trained over 300 U.S. FDA
personnel, but
could not keep up
with the increasing
demand. This
new capacity will
allow us to meet
the needs of the
industry and the
demand from
regulators around
the world,” said
Elliott.
PDA leads the pharmaceutical/biopharmaceutical
industry in developing technical
information and training in the areas of
sterile drug manufacturing, aseptic processing,
and other areas related to the manufacture
and distribution of parenteral drug
products.