04/21/09: PathCon® Announces USP 797 Airborne Microbes Initiative -

Environmental sampling program provides a comprehensive solution for compliance

MYRTLE BEACH, SC. (April 21, 2009, Controlled Environment Testing Association Annual Meeting) PathCon Laboratories, the pathogen control experts, today announced an initiative to assist pharmaceutical compounding facilities with US Pharmacopeia (USP) Regulation 797 compliance. The program provides a comprehensive laboratory analysis solution for facilities looking to evaluate the viable airborne microbial bioburden as described in USP 797.

USP 797 became effective on June 1, 2008 and set forth the first enforceable requirements to ensure that compounded sterile preparations (CSPs) are of high quality in pharmacies and other facilities where CSPs are prepared. The regulations, issued by the USP and recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), address viable airborne particles in compounding facilities and require that an “appropriate environmental sampling plan shall be developed for airborne viable particles based on a risk assessment of compounding activities performed.”

“As the nation’s leading indoor air quality laboratory since 1986, PathCon is uniquely qualified to provide laboratory analyses that help clients meet the necessary bioburden requirements and compliance levels specified in USP 797,” said Brian Shelton, president and CEO of PathCon. “Our program provides a comprehensive response for pharmacies and other compounding facilities looking for a reliable, safe and efficient solution to compliance issues surrounding USP 797.”

As part of the USP 797 viable airborne microbial program, PathCon scientists work with pharmacies and other compounding facilities to develop specific sampling protocols, incorporating appropriate air sampling devices, sample volumes and suitable growth medium for bacteria and fungi as recommended in USP 797. In addition, PathCon offers one-on-one consulting regarding specific sampling locations, collection methods, sampling frequency, and volume of air samples.

For additional information on PathCon’s USP 797 viable airborne microbial compliance programs, please visit http://www.pathcon.com.

About PathCon

PathCon Laboratories, the pathogen control experts, was founded in 1986 by former CDC scientists to provide services in indoor air quality for the private sector. The company has since evolved into one of the nation’s most respected outbreak, laboratory and consulting resources. It provides Fortune 500 companies, environmental health firms, engineering firms, industrial hygienists, hospitals, pharmacies and the hospitality industry with expertise in microbiology, infectious diseases, epidemiology, medicine, and disease prevention. PathCon’s world-renowned experts make the decisions that craft government policy and industry standards that other labs follow. PathCon delivers the most accurate, high-quality, expert laboratory analysis and consulting to its clients, setting the lab-testing standard for the life sciences industry. For additional information, visit www.pathcon.com.