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PDA Adds ISO Class 8 Cleanroom to TRI

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.