Company will exhibit its high-throughput Rapid Detection system for pharmaceutical manufacturers, including the Advance™ luminometer, Advance.im software, and AKuScreen™ reagents. Based on exclusive AK-enhanced ATP bioluminescence, the company’s rapid screening method detects microbial contamination in finished goods, raw materials, and in-process solutions within 24 hours, versus 3-7 days for traditional limits testing. Replacing the compendial 14-day sterility test, customers are using the system to obtain fast results, some in as few as 2 days for in-process sterility testing. Using the system reduces manufacturing lead times and inventory requirements. The system is easy to implement, easy to use, and flexible, meeting a wide range of product types with the highest throughput. With two drug master files (DMFs) on record with the U.S. FDA, the system is an acceptable method under the USP Chapter <71> Sterility Test, harmonized USP <61> and <62> for testing non-sterile products, and is the subject of the proposed USP <1223> Rapid Microbial Methods. Applications for using rapid methods have been accepted by all major regulatory bodies worldwide. There is the option of outsourcing rapid microbial detection to Celsis Analytical Services. With two U.S.-based accredited CGMP laboratories, the service offers a cost-effective outsourcing alternative for rapid screening. If needed, the Celsis laboratories also provide enumeration and identification of organisms at the genetic level.
Celsis International, Chicago, IL 60654. www.celsis.com or call 312-476-1200
INTERPHEX New York 2010 Booth No. 450