Facility Profile — West
Updating and expanding cleanrooms for the manufacture of
wearable medical devices.
Editor West Pharmaceutical Services, a manu- facturer of packaging components and elivery systems for injectable drugs and healthcare products, recently expanded
capabilities at its facility in Scottsdale, Ariz. The
site, first built in 1978, underwent a complete reno-
vation in 2011 to transform the facility and enable
manufacturing in ISO 7 controlled environments.
It features three ISO 7 (Class 10,000) and one ISO
8 (Class 100,000) controlled environments for the
manufacture of products. The facility’s latest update
will accommodate the company’s pursuits into
Controlled Environments spoke with West
Pharmaceutical Services about its recent facility
What kind of instruments and equipment are used
in the clean area?
All production at the facility takes place in con-
How many employees do you have, and from
trolled environments, including plastic molding,
automated assembly, and primary product packag-
ing. Instrumentation includes particle inspection
booths, product test, and in-process measurement
instrumentation. All controlled environments
are continuously monitored by an automated
monitoring system that tracks particulate levels,
pressure differential, temperature, and relative
where are they recruited? What kind of educa-
tional background do they have?
There are more than 100 employees at the facility. Employees come from a variety of industries
including — but not limited to — aerospace,
general manufacturing, and medical device.
Educational backgrounds also vary, but primarily include engineering, microbiology, business
administration, finance, and information technology.
Describe the cleaning process — does your
research staff perform these duties, or do you hire
We perform our own cleaning. Controlled environments are cleaned once a week and gowning rooms
are cleaned daily with LpH. Once a quarter, we use
bleach solution in the cleanrooms
and gowning rooms as sporicidal
Do you have a separate area for
Controlled environments have a
separate gowning area which is
certified and qualified annually
along with the actual controlled
environment per the ISO 14644
standard. All gowning areas
are constructed based on the
cascade, or higher to lower air
pressure principle to assure any
air flow moves from a cleaner to
less clean area. Additionally, all
access doors are interlocked to
provide an air lock between the
cleanroom and ambient plant
Services’ Scottsdale, Ariz.