Founded in 1980 and headquartered in Easley, South Carolina, Ortec offers custom materials used in medical devices, pharmaceuticals, and other health-related FDA/EMA regulated industries. Phase One of the project includes a 26,000ft2 dedicated cGMP manufacturing facility which will give Irish and European manufacturers a local option when looking to source new or existing process chemicals where quality and consistency are critical parameters.
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In addition to product synthesis, other facility capabilities include USP/EP generated water, a full-service analytical laboratory, and an ISO 8/Class 100,000 Clean Room. The site is intended to be ISO 13485 certified and will operate under FDA/EMA guidelines for production of pharmaceutical, combination, and medical device materials.
Ortec Site Manager Colm Maguire said: "Ortec has been offering its products and services solely from its base in South Carolina to its global customers. I am pleased and excited to announce that we have started construction of Ortec’s facility in Newcastle West. This facility, the first for us outside of North America will give European customers a contract manufacturing option which will be completed and available mid-2022."
