Agilent Technologies’ LC/MS Manufacturing Achieves ISO 13485 Certification
News Sep 12, 2011
Agilent Technologies Inc. has announced that its liquid chromatography/mass spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems, are now manufactured under ISO 13485 certification.
This is an internationally recognized standard of quality management for the design and manufacture of medical devices.
“This is just the latest step that Agilent has taken to clear the way for use of our life science tools in the clinic,” said Gustavo Salem, Agilent vice president and general manager, Biological Systems Division.
Salem continued, “We’re also in talks with the FDA about requirements for clearing a number of our platforms, and we’re being very methodical and deliberate about this.”
“These systems are well-proven in toxicology, clinical research, metabolomics, proteomics and chemical analysis,” added John Fjeldsted, Agilent general manager, LC/MS.
Fjeldsted continued, “There’s value in having the additional validation of an ISO 13485-registered quality management system on top of our own high standards of quality design and manufacturing as we pursue approval for the clinic.”
In March 2010, Agilent achieved ISO 13485 certification for the design and manufacture of its entire portfolio of DNA microarrays and microarray scanner platform.
Agilent analytical instrumentation systems and microarray systems produced at the company’s Santa Clara, Calif., facilities have been manufactured under an ISO 9001:2008-certified quality management system since April 2009.
In June 2011, Agilent announced that its Cedar Creek, Texas, reagent manufacturing facility has been registered with the U.S. Food and Drug Administration as a medical device establishment. This registration is required for the manufacture of diagnostic products.
By leveraging an organ-on-a-chip model and a bioreactor, four human gut metabolites have been identified that can help explain the enhanced sensitivity of the human colon towards enterohemorrhagic E. coli, which is responsible for more than 100,000 infections per year in the USA alone.READ MORE