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. Serving retail
pharmacies, long-term care and in-home care providers and 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.
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
CASE STUDY
cintas.com/cleanroom
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
guidelines outlined in the 2022 revision of Annex 1, which requires a dedicated laundry facility and
the use of qualified processes to ensure clothing is not damaged or contaminated.
From an operational standpoint, sterile manufacturers, such as Nephron, face challenges with
cleanroom garments being flexible and comfortable. “Some of our people can be in the cleanroom
for an extended period of time making life-saving medications for hospitals,” says Deirdre Toomer,
503B operations manager. Kennedy agrees, adding, “When you’re asking technicians to spend
hours in a sterile environment, comfort isn’t a nice-to-have — it’s essential.”
This is where Nephron was running into issues with their previous supplier, explains Toomer —
both with the material and the sizing. Previously, the company’s cleanroom apparel was issued
in matched sets, tops and bottoms of the same size. If someone took a smaller shirt size than
pant size, or vice versa, they typically went with the larger size. “We ended up having people who
were literally swimming in extra fabric,” says Toomer. In some instances, they even experienced
shortages. “I had one technician out of the cleanroom for about two weeks because we didn’t
have access to the right-size apparel.”
Garments were made from an extremely slippery material, so sleeves and booties often slipped
down and had to be adjusted. Hoods also weren’t flexible enough in their sizing to accommodate
different hairstyles. If someone with long hair or a lot of hair wanted to put it up, their hoods
might shift and expose a small amount of skin on the back of their necks. As a result, technicians
were constantly fidgeting with tech suit tops and bottoms as well as sleeves, booties, and hoods.
“Our staff doesn’t need the additional complications or distractions from apparel that doesn’t fit
properly when they are working in such a critical setting,” says Kane.
It can take a long time to qualify and train people to work in the cleanroom, so retention is always
important. “We’ve found that if someone is uncomfortable or needing to readjust their clothing for
hours at a time, day after day, it can impact whether they want to stay in the cleanroom or move to
another part of the business,” says Toomer.
Beyond these challenges, Kane says Nephron had no transparency. “We would often be billed for
damaged garments, but there was no information as to what was damaged and no photographs
to help us understand how the damage was occurring.”
SOLUTION: STANDARDIZED GARMENTS, SMARTER
INVENTORY, AND FULL VISIBILITY
When the potential risk of compromising contamination controls became too great, Nephron
turned to Cintas, a leader in business services that provides uniform rental and cleaning, as well
as a range of facility services and fire and safety products. “Cintas was already supplying our
cleanroom shoes, so we were familiar with them and happy with their product and service,”
says Kane.
While ensuring compliance with Annex 1 guidelines and addressing immediate fit and inventory
challenges were critical, Nephron was also looking for a partner who would support continuous
improvement. Cintas delivered on all fronts.
When Nephron conducted an audit of the Cintas facilities as part of its supplier qualification
program, Kane says they saw firsthand the procedures and standards
in place. This includes a validated laundry and packaging process, as
“
“
When you’re asking
technicians to spend
hours in a sterile
environment, comfort
isn’t a nice-to-have —
it’s essential.”
Cintas really goes
above and beyond
to make sure they’re
meeting the needs
of their customers.
I think that’s what
really sets them apart
from many vendors.”
Lou Kennedy
Owner
~ Nephron Pharmaceuticals
Aubrey Kane
Senior Director of Sterility
~ Nephron Pharmaceuticals
CASE STUDY
cintas.com/cleanroom
well as cleanroom certifications for the area where apparel is folded before it’s packaged. “Having
the confidence in their compliance, which helps us stay compliant, is everything to us,” says Kane.
In terms of the apparel, what they noticed right away — particularly about the tech suits — was the
fabric used, which is probably the most critical factor for comfort. Not only was it made of a low-
particle shedding material, but it was also incredibly breathable. The game-changer, however, was
the vending process. “There’s complete flexibility,” says Kane. “There are over 1,000 individual tops
and bottoms in the vending machine and employees check out whatever size top and whatever
size bottom they need for that day.” That means employees can easily change sizes day to day
if needed.
The vending system also gives Nephron an audit trail of inventory for complete transparency.
“If a garment is damaged, we know Cintas will provide us with photographs and other specifics
like what shipment the apparel came from, what the size and what the lot number was,”
says Kane. This helps the company narrow down when and how the damage occurred, and
they can fine-tune processes to avoid future issues.
That flexibility extends beyond sizing to the Cintas customer service approach. Nephron’s
contracted delivery day is Thursday. Of course, in the U.S., Thanksgiving falls on a Thursday
every year. “We were concerned we might be faced with a shortage of cleanroom apparel if we
missed a delivery,” says Kane. When she reached out to Cintas, they immediately moved their
regular delivery up so they wouldn’t have to wait two weeks for new garments. As a result, there
were no interruptions or disruptions in cleanroom apparel inventory.
In another instance, Nephron needed to adjust the allocation of garments by size. “Usually, when
you enter into an agreement as we have with Cintas, you commit to certain sizes and quantities
for a set period of time — whether six months or a year,” says Kane. “They let us make the change
even though, contractually, they didn’t have to.” In both examples, she adds, Cintas understood
and immediately met Nephron’s need. “Cintas really goes above and beyond to make sure they’re
meeting the needs of their customers. I think that’s what really sets them apart from many vendors.”
RESULT: A LONG-TERM PARTNERSHIP BUILT ON
RELIABILITY AND RESULTS
With Cintas as a partner, Nephron knows it can count on the durability, performance, and fit of
their cleanroom apparel. “I love that the product from Cintas is the same every time,” says Toomer.
For technicians working long hours in a highly controlled environment, that consistency matters.
“Not just the material for comfort, which is really fabulous, but the ability to mix and match sizes,”
she adds. “Now our techs don’t have to worry about how their tech suits fit. They only worry about
their aseptic technique in the cleanroom.”
That reliability has delivered a measurable impact. In the first year alone, Kane says Nephron
saved approximately $600,000 by transitioning to Cintas reusable cleanroom apparel. “Our plan
is to onboard new products such as lab coats, sterile sleeves, and reusable sterile goggles,”
says Kane. With this, the company estimates it will see $2.4 million in cost savings over a
five-year period.
Just as important, Kane adds, is knowing that Nephron has a partner that takes compliance as
seriously as they do and responds quickly as needs change. “It feels seamless,” she says. “They
understand what’s at stake for us and consistently go the extra mile.” For Toomer, that support
makes a clear difference on the manufacturing floor. “Cintas allows us to focus on producing
reliable, safe medications for patients,” she says. “That’s what matters most.”
“
I love that the Cintas
product is the same
every time … Not
just the material for
comfort, which is
really fabulous, but
the ability to mix
and match sizes.
Now our techs don’t
have to worry about
constantly adjusting
their garments. They
only worry about their
aseptic technique in
the cleanroom.”
Deirdre Toomer
503B Operations Manager
~ Nephron Pharmaceuticals
www.cintas.com/cleanroom
COVERALLS
Get the right
coverall for your
specific controlled
environment needs.
FROCKS, ESD
LAB COATS
& SPECIALTY
GARMENTS
Many options to
keep your employees
in the cleanroom
Ready™.
BOOTS AND
SHOE COVERS
The right footwear
for your controlled
environment.
GOGGLES
Protective eyewear
for your team.
Gamma sterilization
compatible.
MOPS
Innovative cleaning
solutions at your
fingertips.
WIPES
Cleanroom cleaning
wipes delivered with
your gowning.
CLEANROOM
RESOURCES
Gowning Service to Help Keep Your
Controlled Environment
Ready for the Workday®
PROTECT YOUR PEOPLE.
PROTECT YOUR PROCESS.
When you need Cleanroom garments — and the
peace of mind that comes with them — Cintas
delivers. With strategic ISO 5 Cleanrooms across
the U.S., we support a diverse range of industries.
COUNTLESS
SOLUTIONS
ONE SUPPLIER