AAIPharma Services Completes Expansion At Its Charleston, South Carolina, cGMP Parenteral Production Facility
“Some exciting features of the expansion include low line loss and in-line weight check capabilities, which are extremely important to our clients with high-value active pharmaceutical ingredients,” said James Fife, Senior Director of Parenteral Operations. “In the coming months, the pilot and production-scale SP Hull lyophilizers will be brought online affording seamless lyophilization cycle optimization and scale-up.”
AAIPharma doubled the facility’s sterile product development and production capacity. In addition state-of-the-art redundancies were added to its major processing equipment. Final validation activities are underway and the new suites will be fully operational by February. The buildout was engineered to readily accommodate the production-scale lyophilizer upon arrival, which will more than triple the facility’s lyophilization capacity by late 2014.
The expansion consisted of three new suites that were designed and built by AES Clean Technology, Inc. and equipped with a Chase-Logeman monoblock FSAS, Lytzen ISO Class 5 depyrogenation oven, BMT Steripro cGMP steam sterilizer, and SP Hull pilot-scale lyophilizer, with a complementing production-scale lyophilizer on order, both with ControLyo technology.
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