Component manufacturing process designed with Quality by
Design principles meets the high-quality needs of
pharmaceutical manufacturers and patients
PHOENIX, Apr 16, 2012 (BUSINESS WIRE) --Annual Meeting of
the Parenteral Drug Association (PDA) -- West
Pharmaceutical Services, Inc. (NYSE: WST), a global leader
in innovative solutions for
injectable drug administration, today introduced a new
line of high-quality components under its NovaPure brand at
the PDA Annual Meeting. Through a product development
process that incorporates Quality by Design principles,
NovaPure components, including serum and lyophilization
stoppers and syringe plungers, will help to ensure the
safety, efficacy and purity of injectable drug products.
"Quality by Design is an essential element in helping
pharmaceutical manufacturers meet regulatory guidelines for
safety and efficacy," said Donald E. Morel, Jr.,
Ph.D., West's Chairman and CEO. "West is embedding
QbD in manufacturing from raw materials through delivery.
NovaPure components incorporate a variety of high-quality
processes and features designed to ensure component
reliability and provide an unrivaled level of quality for
our customers, which ultimately can aid in the safety and
efficacy of their drug product for the patient."
Help pharmaceutical companies lower total cost of
Will improve transparency between component and
Ensure quality driven by patients' needs
Are manufactured with the deepest product and process
For NovaPure components, West developed a comprehensive
quality target product profile (QTPP) based on the needs of
its customers and their end users. Critical quality
attributes (CQAs), determined with the patient in mind,
have been built into the development process to help ensure
quality, safety and efficacy throughout a drug
product's lifecycle. Features and processes that help
to ensure reliability include:
FluroTec(R) barrier film - a proven, effective barrier
against extractables that provides lubricity without the
need for silicone oil
Validated wash and sterilization processes that help
ensure consistency of stopper preparation
100 percent vision verification to assure low particles
Lot-to-lot extractable profile to assure material
NovaPure components are available globally with reduced
lead time and are provided in optimized packaging that
helps ease transition through manufacturing environments.
The components are supported by a series of unique service
features that help assure the latest compliance and
customer satisfaction requirements are met.
For more information, please visit
West's innovative system, device and component
solutions help improve the safety and administration of
injectable drugs. West's proprietary materials science,
formulation research and manufacturing technologies advance
the quality, therapeutic value, development speed and rapid
market availability of pharmaceuticals, biologics and
vaccines. Sales in 2011 totaled US$1.2 billion.
West supports its customers from sales, manufacturing,
customer support and research and development from
locations in North and South America, Europe, Asia and
Australia. Global headquarters are in Lionville, Pa., USA.
Visit West online at
www.westPFSsolutions.com. Follow us on Twitter:
NovaPure and FluroTec are trademarks or registered
trademarks of West Pharmaceutical Services, Inc. in the
United States and other jurisdictions. FluroTec technology
is licensed from Daikyo Seiko, Ltd.
SOURCE: West Pharmaceutical Services, Inc.
Kristin Villiotte, 781-684-0770