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Donna Shelton

Carabiner Communications

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PathCon^® Shares Strategies for USP 797

Microbial Compliance in New White Paper

Quality, Credentialed Environmental Health Firms Can Help Facilities Meet Regulations

NORCROSS, Ga. (November 19, 2009) PathCon Laboratories, the pathogen control experts, today made available a new white paper developed to help compounding facilities, pharmacies and other sites where compounded sterile preparations (CSPs) are produced comply with microbial control regulations in USP 797.

Entitled “The Microbial Bioburden of USP 797 Compliance: Simplifying Environmental Quality and Control Practices for Pharmaceutical Compounding,” the new paper explores the history and development of the first enforceable standard, while focusing on the quality and control aspects of USP 797 as they relate to the immediate environment in which CSPs are prepared.

PathCon’s white paper follows the spring 2009 launch of its USP 797 program, which provides a comprehensive response for pharmacies and other compounding facilities looking for a reliable, safe and efficient solution to microbial compliance issues. Since launching the program, PathCon has successfully assisted numerous clients in developing specific sampling protocols – including the use of appropriate air sampling devices, sample volumes and suitable growth media for bacteria and fungi as recommended in USP 797. In addition, one-on-one consulting regarding specific sampling locations, collection methods and sampling frequency has helped clients ensure product sterility and safety in their CSP environments.

“The USP 797 regulations are essential in the production of CSPs that are free from potentially deadly microbial contamination. Although companies want to comply, the guidelines are complex in nature and scope,” said Brian Shelton, president and CEO of PathCon. “We created the white paper to educate facilities on the quality and control aspects of USP 797 regulations and to provide solutions to our clients’ practical questions on the microbial facets of compliance.”

The paper can be downloaded without charge from the PathCon website at http://www.pathcon.com/documents/MB_USP_797.pdf.

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.