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Ortec's cGMP Facility

In 2002, Ortec, Inc. began manufacturing services in a new cGMP-dedicated facility. The 30,000 square foot facility is located on 13 acres, includes laboratories, pilot manufacturing suites, and full-scale production areas. The production area contains an assortment of manufacturing equipment ranging in size from 150 gallons up to 2,500 gallons. Materials of construction include glass, Incoloy, and 316 stainless steel. Temperatures range from 25 degrees C up to 315 degrees C, with vacuum capabilities down to less than 1 Torr. Auxiliary equipment includes full overhead condensers, jacketed receivers, and a Rosenmund filter-dryer for solids/liquids handling. Each vessel is configured with process automation for optimal quality control.

All chemical handling sections of the facility have been designed as low particulate environments. Each area also contains UV-filtered lights and windows in order to accommodate UV-sensitive chemistries. Ortecís facilities are routinely inspected for compliance with cGMP standards.

Ortec has been offering its quality services to a wide range of customers since 1980. Ortec helps its customers meet their outsourcing needs by providing quality, flexibility, and speed to market through its manufacturing and development services.

 

Ortec, Inc
Phone: 864-859-1471 or email.
PO Box 1469 Easley SC 29641