The new Plough Center for Sterile Drug Delivery Systems at the University of Tennessee Health Science Center is moving toward completion in late August or early September, and will expand the university’s role as a pharmaceutical developer and manufacturer. Meanwhile, the university is also building on its long history of educating and training individuals in sterile pharmaceutical preparation.
Thirty people representing 13 pharmaceutical companies, including Amgen, Bristol-Myers Squibb, SP Scientific and others, came to UTHSC recently to learn about the preparation of parenteral (non-oral) medications. More than 100 such courses have been taught since the Plough Center’s inception in 1963. This year, training sessions are being held quarterly at the center’s current location in the Van Vleet Cancer Center at 3 North Dunlap Street. The next training is set for mid-August.
The new Plough Center facility under construction at 208 S. Dudley Street will expand the center’s missions of educating individuals in sterile product preparation, developing research and processes in parenteral medications, and providing services to the pharmaceutical and health care industries. The building will house three 800-square-foot prefabricated PODs, which will serve as sterile environments for aseptically manufacturing pharmaceuticals. The PODs will allow the facility to attain and maintain aseptic conditions as specified by Good Manufacturing Practices (GMP) guidelines, the pharmaceutical industry’s standard for sterile facilities. The building will also house roughly 10,000 square feet of support labs, offices and training facilities.
The most recent training session, led by Nivesh Mittal, PhD, and Bivash Mandal, PhD, senior research specialists at the Plough Center, was a 40-hour course providing a comprehensive overview of the fundamental concepts for preparation of parenteral products. Participants worked in teams to prepare small-volume products and perform quality control tests and environmental evaluations. Emphasis was placed on sterilization processes and proper procedures and techniques employed in aseptic processing.
“Dr. Kenneth Avis started this as a two-week course to train FDA inspectors for sterile facility inspections,” said Dr. Mittal. “It was later changed to a one-week format to accommodate the schedules of participants from the industry.”
Most of the participants who attend the trainings are personnel who have been newly hired by a company to work in the sterile products area or those who have been reassigned within a company. This course acts as a certification, and gives a bird’s-eye view of all the processes involved.
“We also get participants from Health Canada frequently,” Dr. Mittal said. “Health Canada is the FDA counterpart in Canada. We get participants from sales, marketing, directors of companies, executives and others, who would like to have an understanding of what their team is doing. Since UTHSC is an educational organization, the Plough Center is fulfilling one of its most important aspects of educational service to the people in the area of aseptic manufacturing.”