Pharmacy cleanroom certified to USP <797>


Vince & Associates adds depth to pharmacy capabilities

The pharmacy cleanroom at Vince & Associates Clinical Research has been certified to United States Pharmacopeia USP <797> guidelines.

This certification enables the Overland Park, KS-based provider of early clinical research services to make intravenous and other preparations to the highest clinical research standards.

The pharmacy includes an ISO 8 rated anteroom attached to an ISO 7 individual cleanroom containing a Class A2 biological safety cabinet for sterile compounding.

Scott Smiley, director of Pharmacy Operations at Vince & Associates Clinical Research, said: “This new certified cleanroom adds depth to our existing pharmacy capabilities including a negative pressure extemporaneous drug preparation room and 24-hour video surveillance monitoring.”

Vince & Associates specialises in conducting complex, early development studies such as First-in-Human (FIH) clinical trials that often require sterile compounding. The USP <797> cleanroom allows for the preparation and compounding of a range of investigational compounds.

“The certification of the USP <797> cleanroom highlights our expertise in providing our clients with the pharmacy capabilities needed to generate data quickly to support earlier decisions in drug development,” added Dr Brad Vince, president and Medical Director at the firm.

“Our pharmacy and cleanroom are an integral component in our clinical pharmacology research unit, and allow Vince and Associates to execute highly customised early development studies in both healthy and special population volunteers across a wide array of therapeutic areas.”