Grace Earns Medical Device Certification
COLUMBIA, Md., May 13, 2010 (BUSINESS WIRE) --W. R. Grace & Co. (NYSE: GRA) has earned an additional certification for
the Quality Management System at its facility in Hesperia, California.
This ISO 13485:2003 certification was issued by SGS Inc., a global
provider of certification and testing services, for Class I medical
devices manufactured at this location.
Grace markets to customers in the life science, pharmaceutical,
anesthesiology, forensic and biotechnology industries through Grace
Davison Discovery Sciences. Products include flash chromatography
cartridges and systems, liquid chromatography columns, solid phase
extraction devices, detectors, instruments, accessories, bulk media and
preparative purification columns and systems.
Hesperia joins four other Grace facilities that were previously
certified to the ISO 13485:2003 standard for medical devices: Epernon,
France (certified in 1997); Chicago, Illinois (certified in 2004);
Surat, India (certified in January 2009) and Deerfield, Illinois
(certified in March 2009). Pursuing each certification was a proactive
and voluntary decision by Grace in an effort to test the company's
quality management systems.
"We are very proud that all our facilities manufacturing medical devices
around the world have achieved this certification," said Greg Poling,
Vice President, W. R. Grace & Co. and President, Grace Davison. "Our
customers can be confident that, with Grace Davison, they are receiving
premiere quality products which help pharmaceutical and biotechnology
companies develop drugs more rapidly and efficiently."
As one of several chromatography media manufacturing sites within the
Grace Davison Discovery Sciences product line, Hesperia manufactures and
modifies silica for use in some of the world's leading biotechnology
drugs as well as analytical, preparative and process applications.
This is the second certification focused on the pharmaceutical industry
that Grace has earned in 2010. In March, Grace successfully garnered an
Excipient Good Manufacturing Practices (GMP) certification of its
quality management system in Baltimore, Maryland. That particular
certification verified that Grace's Quality Management System met the
requirements of the Joint International Pharmaceutical Excipients
Council--Pharmaceutical Quality Group GMP Guide for Pharmaceutical
Excipients. Pharmaceutical excipients are inactive ingredients
(additives) used in drug formulations.
Grace is a leading global supplier of catalysts and other products to
petroleum refiners; catalysts for the manufacture of plastics;
silica-based engineered and specialty materials for a wide range of
industrial applications; sealants and coatings for food and beverage
packaging, and specialty chemicals, additives and building materials for
commercial and residential construction. Founded in 1854, Grace has
operations in over 40 countries. For more information, visit Grace's web
site at www.grace.com.
SOURCE: W. R. Grace & Co.
W. R. Grace & Co.