Expanded quality assurance for Sigma-Aldrich facilities

Life science company Sigma-Aldrich has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St Louis, USA. The certification extends the company’s ability to manufacture critical raw materials — such as enzymes, proteins and antibodies used in diagnostic assays — and provides in vitro diagnostic (IVD) customers with quality assurance to meet their needs at a time of increased regulatory requirements.

As a supplier of raw materials to the diagnostic market, Sigma-Aldrich sought to extend its ISO 13485 certification based on its assessment of clients’ current and future needs. The Dekalb site, which manufactures enzymes and proteins, achieved this 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 certification of quality management systems at the Barton distribution warehouse. This site can now serve as a central North American distribution centre for Sigma-Aldrich raw materials designed for use in IVD manufacturing applications.

“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,” said Tom Beil, vice president of quality & regulatory affairs at Sigma-Aldrich. “In turn, they are able to serve their customers — patients — in the most efficient way possible.”