AAIPharma Services Corp. has completed a multi-million dollar expansion of its cGMP parenteral manufacturing facility in Charleston, SC. The expansion includes three new suites designed and built by AES Clean Technology, 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 production-scale lyophilizer, both with ControLyo technology.
AAIPharma doubled the facility’s sterile product development and production capacity and added redundancies to its major processing equipment. Validation is underway and the new suites will be fully operational by February 2014. Also, the new production-scale lyophilizer will more than triple the facility’s lyophilization capacity by late 2014.
“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.”