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Grace Earns Medical Device Certification May 19, 2010
W. R. Grace & Co. 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," says 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.
Source: Grace Davison Discovery Sciences
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