CASE STUDY
cintas.com/cleanroom
A HIGH BAR FOR SAFETY, QUALITY AND COMPLIANCE
Based in West Columbia, South Carolina, Nephron Pharmaceuticals is an FDA-approved
manufacturer focused on sterile, aseptically filled medications. Serving retail pharmacies, long-
term and in-home care providers, as well as hospitals and surgery centers, the company provides
common generic respiratory treatments, such as liquid nebulizer medications, as well as IV drug-
shortage products.
“Every one of our 750 employees is committed to bringing safe, effective, and affordable
medications to patients in need,” says Lou Kennedy, Nephron’s owner. “And since sterility is at the
center of everything we do, we have a high bar to meet in terms of FDA regulations.” That’s true
across all departments, but critical in the cleanroom where sterile preparation takes place.
“The primary challenge for maintaining a cleanroom environment is ensuring that we have
consistent and repeatable control,” explains Aubrey Kane, senior director of sterility. “There are so
many potential sources of contamination when it comes to a dynamic manufacturing setting like
ours — and people’s microbial load is always going to be the highest risk factor.” That’s why, she
says, having the appropriate cleanroom apparel is critical to the process.
A LAYERED DEFENSE: NEPHRON’S CLEANROOM
APPAREL PROTOCOL
Before entering Nephron’s cleanrooms, technicians follow a careful donning process that starts
with putting on a tech suit, the first layer of protection. With this on, they can then move into a
controlled environment that leads to the cleanroom. Here, they sanitize their dedicated cleanroom
shoes, put them on, and place shoe covers over them. They then sanitize their hands, put on their
gowns, hoods, goggles, and sterile gloves. Lastly, technicians put on a sterile coverall, sleeve
covers, and booties.
CHALLENGE: LIMITED FLEXIBILITY, INCONSISTENT FIT, AND
LACK OF TRANSPARENCY
Nephron opts for reusable cleanroom apparel over disposable options and maintaining the
integrity of those garments throughout their lifecycle is essential. That includes following the
Inside the Cleanroom:
Nephron Strengthens
Sterility, Comfort, and
Control With Cintas
Lou Kennedy
Owner
~ Nephron
Pharmaceuticals
Aubrey Kane
Senior Director
of Sterility
~ Nephron
Pharmaceuticals
Deirdre Toomer
503B Operations
Manager
~ Nephron
Pharmaceuticals