‘Clean room’ class to teach proper drug manufacturing

State-of-the-art facility located in Avedisian Hall basement

Posted on
Student in clean room
URI student Ang Can works in the College of Pharmacy clean room in the basement of Avedisian Hall. Photo by Joe Giblin

KINGSTON, R.I. – December 14, 2017 — When a patient leaves a doctor’s office with prescription in hand, he simply heads to the pharmacy, picks up a bottle of pills and swallows one down to begin treating what ails him.

It’s a simple process with which most are familiar. But rarely does the patient consider the behind-the-scenes work of multiple professionals that goes into creating that single prescription. The process is anything but simple.

The market for new, better medications is ever-expanding, and the rapid expansion of the industry has created a critical demand for skilled professionals (from equipment operators to advanced technical and quality assurance personnel) and additional infrastructure to support drug development and manufacturing. URI’s College of Pharmacy is helping fill that void with professionals trained in its state-of-the-art Good Manufacturing Practice (cGMP) Facility.

Student in clean room
The URI College of Pharmacy is home to a state-of-the-art clean room used in drug manufacturing. Pharmacy student Chrissy Nadolny learns about the various machines used to make medications. Photo by Joe Giblin

Located in the basement of Avedisian Hall, the 7,000 square-foot clean room has the purity and sterility of a hospital operating room, necessary for producing medications. A series of fans and an advanced filtration system constantly scrub the environment. The air pressure of each interconnected room and laboratory is lower than the next, ensuring air — and the contaminates it carries — is constantly flowing out.

“You have to design the room to protect the product so you can produce a clean drug with no contamination,” said Jim Vogel, director of the room and an adjunct professor in the College of Pharmacy. “There are very specific procedures that must be followed. If you miss even one step, things can go wrong. One of the biggest risks to a sterile product is the person working in the room.”

To combat such risks, the URI College of Pharmacy is training students and pharmacy professionals in the proper use and function of a drug manufacturing clean room. The College will offer BPS 426 in the spring semester, a course in the proper use and maintenance of a manufacturing clean room.

Students will learn about the various tools used in drug manufacturing, such as V blenders and fluid bed granulators, and the room’s engineered controls, including the fans and filtration system. They’ll also learn about their own critical role in maintaining the room’s sterility, which includes properly gowning, sterilizing themselves, and maintaining cleanliness inside the room, even to the point of using a small, personal fan directed up to prevent eyelashes from falling into their work.

“It’ll be both classroom and hands-on training so they can go and be functional in these places,” Vogel said. “They’re going to get in the room and learn actual clean room operation. We want people to be aware of the environmental risks and how to combat them to make a better drug.”

The clean room class is scheduled to meet on Thursday evenings, 6-8:45 p.m. throughout the spring semester. Just 25 spots are available for pharmacy students and pharmaceutical professionals. For more information, contact Pharmacy Professor Clint Chichester at chichester@uri.edu.