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Verona, WI site provides commercial scale HPAPI
October 26, 2011
By: Tim Wright
Editor-in-Chief, Contract Pharma
Sigma-Aldrich Corp.’s custom manufacturing and services business unit, SAFC, has been granted SafeBridge Certification for its commercial scale High-Potency Active Pharmaceutical Ingredients (HPAPI) facility in Verona, WI. The SafeBridge program assessment focuses on four primary areas: management; hazard identification and evaluation; hazard controls; and communication, education and training. The Verona site opened in April 2010 and was built to support pharmaceutical manufacturers with Phase III and commercial HPAPI needs. The facility is designed to increase efficiencies and safe handling in high-potency production and to adhere to Category IV standards for HPAPI handling and containment. The SafeBridge assessment included the review of health and safety programs, containment equipment testing results, as well as appraisal of material handling and GMP production areas. “The latest SafeBridge Certification status for our Verona facility builds on successful accreditations at our Madison HPAPI plant, which we originally received in 2003, and our HPAPI bioconjugation suite in St. Louis, which was awarded in 2009,” said Dave Bormett, SAFC director of operations. “SafeBridge Certification reflects SAFC’s ongoing commitment to the safety of our staff, and to handle our customers’ potent compound projects safely and efficiently.”
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