Continuing its long history of educating and training individuals in sterile product preparation, the University of Tennessee Health Science Center (UTHSC) Plough Center for Sterile Drug Delivery Systems hosted is first of four hands-on training courses in aseptic processing this year.
The “Comprehensive Industrial Course in the Preparation of Parenteral Products” brought domestic and international participants, including two from Japan.
“In Japan you have no training for aseptic processing,” said Hiroshi Ito, engineering contractor for TPS Engineering. “Many pharmaceutical companies have the facility, they know the aseptic manner by themselves, but for us, we don’t have the facility. So it’s good to experience how to do the aseptic manner.”
Developing a basis for research into parenteral medications and providing services to the pharmaceutical industry, the Plough Center educates individuals in sterile product preparation. The Comprehensive Industrial Course in the Preparation of Parenteral Products is a 40-hour course that provides a complete overview of the fundamental concepts for preparation of parenteral products.
Participants work in teams to prepare a small-volume parenteral (SVP) product and perform relevant quality control tests and environmental evaluations. Emphasis is on sterilization processes and standards of process in proper procedures and techniques employed in aseptic processing.
“We understand clearly the underlying challenges currently pharmacies, hospitals and other manufacturing facilities are facing to meet clinical and patient needs for consistent delivery of high quality sterile parenteral medicinal products,” said Harry Kochat, PhD, director for the Plough Center.
The course is offered in a five-day format with the mornings consisting of lectures on the fundamental principles of cleanroom operations and manufacturing life-cycle management. In the afternoon, sessions are focused on hands-on training to practice and master the techniques, ensuring patient safety and consistent delivery of pathogen free products Dr. Kochat said.
“One of the best things about the course is you get lectures in the morning and then you get to do what you learned in the afternoon,” said Jose Fuxa, senior director of global engineering for Elanco, the animal health division of Eli Lilly and Company. “This is great because experts say we only retain about 5 percent of what were are told. So if we are just listening we only get that 5 percent, but when you do all those activities then your retention is going to be much more.”
Rajan Gupta, director of product development for Celgene, and Kodai Chiba, HAVAC and Architecture for TPS Engineering in Japan, both said that the gowning portion of the course was very beneficial.
“This course was really geared toward that and the details we learned on how to gown and de-gown. You can get lectures on this and that, but nothing beats the hands on training portion,” said Gupta. “The first day you put the gown on…that was something!”
“These courses, of which we are very proud, are but one element of the portfolio of services, including but not limited to analytical testing, pharmaceutical formulation and cGMP manufacturing,” said Ken Brown, JD, MPA, PhD, FACHE, executive vice chancellor and chief operations officer at UTHSC. “The Plough Center intends to offer support to the pharmaceutical industry and researchers involved in new drug discovery.”
More than 100 courses have been taught since the Plough Center’s inception in 1963. The next aseptic processing training course will be offered June 19-23. For more information on how to register visit https://www.uthsc.edu/plough-center/apt/index.php.