New Website Provides USP 797 Information and Testing Services

Recently, EMSL Analytical published a new website dedicated to providing information and testing services to support U.S. Pharmacopeia (USP) 797 guidelines. The USP 797 chapter on “Pharmaceutical Compounding - Sterile Preparations” provides for enforceable guidelines, procedures and compliance requirements for compounding sterile preparations.

These standards include the proper facility design, environmental monitoring, handling and storage of sterile compounds to prevent serious illness or fatalities caused by accidental contamination of these materials. While a significant portion of the USP 797 guidelines pertain to improving air quality in these facilities, an equally important goal is to prevent physical contact with and contamination of these preparations during manufacturing.

The guidelines impact not only the people who prepare compounded sterile pharmaceuticals (CSPs), but also the areas where theses drugs are prepared and stored including commercial and hospital pharmacies, clinics, doctors’ offices and other facilities. USP 797 recommends certain clean area designs, storage specifications, Quality Assurance plans which include environmental monitoring, and employee training programs to accomplish the safe handling of these preparations.

These guidelines specifically address:

  • Microbial contamination
  • Endotoxins
  • Physical or chemical contamination
  • Preparation of incorrect concentrations
  • Incorrect ingredients

“EMSL Analytical offers a wide range of testing services to support USP 797 requirements,” reports Jason Dobranic, Ph.D., Vice President of Microbiology and Life Sciences at EMSL Analytical, Inc.  “EMSL’s USP 797 testing services can help to identify potential problems before they result in human illnesses. These analytical services are available to those involved with CSPs, healthcare professionals, manufacturers and government agencies"

To view the new USP 797 website please visit: www.USP797TestingLab.com.

To learn more about USP 797 testing services or other environmental and indoor air quality issues, please visit www.EMSL.com, call (800) 220-3675 or email info@EMSL.com .

About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of environmental, indoor air quality and materials testing services and products to professionals and the general public. The company has an extensive list of accreditations from leading organizations as well as state and federal regulating bodies.

Contact Information

Joseph Frasca

Senior Vice President of Marketing

EMSL Analytical

(1) 1-800-220-3675

jfrasca@emsl.com