PDA Builds Teaching Cleanroom
By Lisa A. Karter
Bethesda, MD–Early next year, the Parenteral Drug Association (PDA) plans to open a training institute for laboratory-based practice pharmaceutical education. In addition, the PDA plans to design and build a cleanroom in the Institute that will be used for contamination control technology and teaching.
The PDA Training Institute will be housed at the University of Maryland Baltimore County (UMBC) Technology Center in Catonsville, Maryland. About 11,000 ft2 of laboratory and classroom space will be available for hands-on laboratory-based education in various aspects of pharmaceutical processing and quality control technology. According to PDA President Edmund M. Fry, a cleanroom will be constructed with design help from the Institute`s students.
The cleanroom will be a Class M3.5, also known as Class 100. Says Fry: “It is our intent to construct a cleanroom to a pharmaceutical aseptic processing standard.” Although the approximate size of the cleanroom has not yet been determined, Fry expects the cleanroom to be about 1,500 ft2 at the most. “Although it will not be used for manufacturing drug products, it will be used for teaching various cleanroom technologies and uses (cleaning, gowning, monitoring, filling, sterility testing, etc.) and we believe it is important that the facility be comparable in quality to industrial installations,” adds Fry.
At the Institute, three- to five-day classes will be offered using commercial processing and analytical equipment. Courses on particle counting, calibration and metrology, and isolator systems will be among the first offered. Further courses will be added as quickly as possible as the laboratory expands to cover sterilizer validation, lyophilization, environmental monitoring, HVAC systems (including HEPA filter integrity testing, pressure differentials and air changes), aseptic practices, gowning techniques, sterilizing filtration validation, and other technologies.
PDA plans to offer a broad range of pharmaceutical technology courses and will not be limited to sterile products technology. The architect for the institute is Design Collective, Inc. (Baltimore, MD), but the cleanroom`s builder has not yet been chosen, according to Fry. In addition, the Institute is considering the option of installing a modular cleanroom.
“The Institute will constitute a valuable resource for the pharmaceutical industry in meeting the educational challenges of pharmaceutical scientists in the years to come,” says Fry. n