ST. LOUIS, July 23, 2015 /PRNewswire/ –
Sigma-Aldrich Corporation (NASDAQ: SIAL), a leading life
science and high technology company, today announced the Company
has received ISO 13485 certification for expanded quality assurance
capabilities at its Dekalb and
Barton facilities located in
St. Louis. The certification
extends Sigma-Aldrich's ability to manufacture and offer critical
raw materials, such as enzymes, proteins and antibodies used in
diagnostic assays, and provides in vitro diagnostic (IVD) customers
with industry-leading assurance of consistent quality to meet and
exceed their supply chain needs at a time of increased regulatory
requirements.
The Dekalb site, which
manufactures enzymes and proteins, achieved the ISO 13485
certification following significant investments in production and
packaging facilities as well as personnel training. A similar
commitment to invest in capabilities for the diagnostics customer
segment enabled ISO 13485 certification of quality management
systems at the state-of-the-art Barton distribution warehouse, that can now
serve as a central North American distribution center for
Sigma-Aldrich raw materials designed for use in IVD manufacturing
applications. These two St.
Louis-based sites join the growing roster of ISO 13485
certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which
manufacture antibodies and enzymes, as well as the St. Louis Ewing
site, which provides OEM assay manufacturing services to diagnostic
customers.
As one of the leading suppliers of raw materials to the
diagnostic market, Sigma-Aldrich made an investment to extend its
ISO 13485 certification based on the Company's assessment of
clients' current and future needs. Sigma-Aldrich continually invests in quality
assurance initiatives and has 44 Quality Control laboratories
worldwide, as well as approximately 800 employees within the
Sigma-Aldrich Quality organization.
"Our continued investment in facilities, processes and personnel
represents Sigma-Aldrich's ongoing commitment as a leader in
quality and supplier to the regulated life science industries – in
particular for our strategic partners in the diagnostics customer
segment," said Tom Beil, Vice
President of Quality & Regulatory Affairs at Sigma-Aldrich.
"Improving the reliability of raw materials and reducing risk in
the supply chain are crucial for our IVD customers and are enabling
factors when bringing new assays to market faster. In turn, they
are able to serve their customers – patients – in the most
efficient way possible."
Theresa S. Creasey, Vice
President of Diagnostics & Testing at Sigma-Aldrich, added, "We
are able to achieve the necessary certifications to meet the
requirements of our diagnostics and clinical testing customers by
making a significant investment in our facilities, our quality
systems and our employees. Sigma-Aldrich is committed to the diagnostic
industry and will continue to take the leadership position in
providing critical raw material, fit for purpose, and together with
our customers, realize our mission of enabling science to improve
the quality of life."
To learn more about Sigma-Aldrich's extended quality assurance
offerings and ISO 13485 certification, visit
http://www.sigmaaldrich.com/customer-service/quality-systems/iso-certification.html,
or download our Quality Programs App from the Apple store.
About Sigma-Aldrich: Sigma-Aldrich, a leading Life
Science and Technology company focused human health and safety,
manufactures and distributes 250,000 chemicals, biochemicals and
other essential products to more than 1.4 million customers
globally in research and applied labs as well as in industrial and
commercial markets. With three distinct business units - Research,
Applied and SAFC Commercial - Sigma-Aldrich is committed to
enabling science to improve the quality of life. The Company
operates in 37 countries, has approximately 9,300 employees
worldwide and had sales of $2.79
billion in 2014. For more information about Sigma-Aldrich,
please visit its website at www.sigma-aldrich.com.
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SOURCE Sigma-Aldrich Corporation