Duke Raleigh Hospital is the first healthcare facility to use a certified USP 797 mobile cleanroom to provide uninterrupted pharmacy services.

The advanced pharmacy unit, created by Germfree Labs, allowed the hospital to maintain separate, on-site sterile drug compounding operations during a major renovation project.

During building renovations it is imperative that IV compounding operations are not interrupted or otherwise negatively impacted. Full compliance with all regulations is critical to ensure an environment for safe and aseptic compounding of pharmaceuticals.

Duke Raleigh worked with Germfree, the Florida manufacturer of the turnkey mobile USP 797 pharmacy-cleanroom. The fully equipped unit was engineered to provide the advanced functionality and ample capacity required for a hospital compounding operation.

A range of challenges

The remodeling of a hospital pharmacy presents a range of difficult challenges to maintaining sterile drug compounding operations. “Traditional approaches are cumbersome and costly,” according to Sal Golfo, general manager of Germfree’s Pharmacy Division. Some facilities are forced to renovate one section at a time, extending and complicating the project. Other hospitals resort to outsourcing their compounding, which adds cost and impedes workflow.

“The mobile pharmacy was the perfect platform to continue all operations on-site,” according to Gene Woodall, Duke Raleigh’s director of Pharmacy.

“We were able to deliver vital sterile compounded preparations without interruption while maintaining our extensive quality assurance protocols and rigorous standards for product sterility. Concurrently, renovations to improve our main facility commenced with absolutely no impact on compounding services.”

“Our challenge was to design and deliver a complete mobile pharmacy that would be immediately operational. It was imperative that the unit provide a comfortable workspace equipped to facilitate all sterile or hazardous drug services conducted in a traditional building,” said Golfo.

The mobile pharmacy has distinct, controlled work zones engineered as ISO 7 environments. The Hazardous Drug Preparation Room operates under negative pressure and is equipped with Class II Biological Safety Cabinets. The Sterile IV Preparation Room operates under positive pressure and is equipped with Laminar Flow Workstations.

“During the initial planning of our renovation project, we knew we needed an innovative plan to maintain the output levels and quality standards required for our sterile compounding services,” said Gene Woodall in a statement.

“Germfree’s mobile pharmacy provided an advanced, comprehensive unit with all the resources we needed to provide seamless sterile compounding during the renovations at Duke Raleigh Hospital.”