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TriStar Summit Medical Center

Altro proves to be USP 797 compliant in Tennessee compounding facility

Altro Reliance 25

TriStar Summit Medical Center’s compounding pharmacy in Nashville, Tennessee creates compounded  prescription medication for patients with needs that otherwise cannot be fulfilled by commercially available drugs. In order to comply with health codes USP 797, described in detail below, this facility must adhere to strict surface guidelines and even use negative airflow containment isolators to reduce the risk of contaminating a compound medication in the process of making it.

To meet these exacting standards, Summit chose Altro Whiterock and Altro Reliance 25 to create the clean environment critical for areas in which pharmaceuticals are created and/or mixed. Their USP 797 inspection was passed with flying colors and the inspectors were very satisfied with Altro products. They also noted that recently other compounding facilities that didn’t install Altro products actually failed their USP 797 inspections.

Why are there such strict regulations? In 2012, a compounding facility in Massachusetts was the source of a major outbreak in which prescription drug  compounds were contaminated with Aspergillus mold. This unfortunate outbreak led to patients getting severely sick and even caused deaths.

After this outbreak, The U.S. Pharmacopeial Convention began strictly enforcing their regulations. USP is an organization that puts standards in place for the quality and purity of medicines. The existing code, USP 797, was put in place to prevent the improper handling and contamination of sterile compounds. The code has guidelines for the people who prepare the sterile compounds, and the areas where the drugs are prepared and stored.

To be USP 797 compliant the cleanroom’s surfaces, including walls and floors, should be made of smooth, impervious, and seamless materials. Vinyl sheets with heat-welded seams are optimal for these environments.

Altro offers the only hygienic wall and safety floor system in the industry. Together, Altro safety flooring and Altro Whiterock prevent water and mold penetration from floor to ceiling creating a seamless, impervious and water-tight solution. This seamless finish allows surfaces to be thoroughly cleaned and disinfected efficiently and leaves no area for harmful bacteria and microorganisms to hide.

Download the TriStar Summit Medical Center PDF