Pharm Tech: Robotic Automation Boosts Efficiency and Quality in Drug Compounding

Robotics in compounding facilities

A pharmaceutical manufacturing company adopting cutting-edge robotic technology for its CGMP 503B operations is Nephron Pharmaceuticals in South Carolina. The company, which specializes in producing generic respiratory medications using a fully automated process with blow-fill-seal (BFS) technology, launched its division for sterile compounded drugs in 2017 and began with manual operations, in which pharmacy technicians worked inside laminar-flow hoods to fill parenteral solutions coming from sterile filtration into intravenous (IV) bags or syringes. Now, Nephron is moving to robotic systems inside of the laminar-flow hood to perform these fill/finish operations. The company worked with the University of South Carolina (UofSC) and Clemson University in two separate projects to custom design robots for this application. In April 2021, Nephron validated the UofSC system and began commercial production, says Lou Kennedy, CEO of Nephron. A second robot is already being built, and more are planned. “We’re producing drugs on FDA’s drug shortages list, and this 503B space is growing,” she says. Robotic systems will improve productivity, reduce the burden of repetitive physical work for operators, and provide better accuracy and precision. Future projects will seek to increase speed of the robots to obtain higher throughput.

In addition to being used in commercial production at Nephron, Kennedy would like to see the robotic systems licensed to hospital compounding facilities. “What I love about both the Clemson and UofSC projects is that as we collaborate with both undergraduate and graduate students, we’re helping develop future industry employees,” says Kennedy.

Preparing the workforce

Although a common fear is that robots will eliminate people’s jobs, Kennedy says this concern is unfounded. “Robotics is not eliminating people; it’s teaching people to have new skills to operate automation,” she notes. “Operators need to learn how to service the robot and work with it, to solve a jam or replenish components, for example. Operators are also needed for quality functions.”

Kennedy notes that Nephron sees a need for more pharmacy technicians, and the company works closely with local schools to help develop the future workforce. For example, Nephron built a sterile compounding lab on the nearby UofSC campus that is used to train pharmacy students at the university as well as two-year students from the local technical college in using robotics in sterile compounding.

Both developing an understanding of how robotics works and specific training with the equipment and its functions are key, adds Fraatz. “It is a new approach, which means trust needs to be gained, starting from education and understanding, so people can appreciate the purpose of robotic automation. Once they believe in the purpose, they can grow their familiarity and comfort with it.”

Read the entire story at PHARM TECH.