Pacific West Pharmacy (PWP) and Advantage Pharmaceutical Inc. (API) of Rocklin, Calif., service long-term care facilities and hospitals throughout California. PWP dispenses prescription drugs and API specializes in compounding custom medications unavailable commercially. To ensure the drugs are produced and stored according to their strict standards, the FDA and U.S. Pharmacopoeia 797 regulate and annually audit environmental controls used in pharmacies and pharmaceutical-compounding facilities such as PWP/API, creating the need for accurate, reliable environmental-monitoring solutions.
To satisfy this need, PWP/API had tracked environmental conditions manually. More recent regulatory audits, though, had indicated that the manual method used by the company had shortcomings in tracking temperature and humidity data. The search for an economical, real-time, wireless solution, and Troy Whitney, information technology manager for PWP/API, ultimately found the device that satisfied his application in DeltaTrak's FlashLink wireless system. Installed in 2005 to record temperature and humidity in the laboratory's medication refrigerators and cleanrooms, the wireless system includes three repeaters and seven wireless temperature and humidity sensors. The system, which was placed in two buildings, includes one 900 MHz receiver with a PC interface unit and server software. The wireless system manages up to 100 temperature or humidity sensors and, with the addition of the software for wireless operation, allows users to access data remotely at any time.
“With the automated process, we get real-time information displayed on the computer with multiple alarm-notification options,” says Whitney. “In addition, the data-management and reporting capabilities make record compilation for regulatory audits simple. The system quickly justified our investment by helping us efficiently monitor the environmental conditions of compounded medications worth from $100,000 to $200,000, and has led to improvements in our overall operating efficiency.”
Since installation, the 21 CFR Part 11-compliant system from DeltaTrak Inc., Pleasanton, Calif., has performed continuously while satisfying PWP/API's environmental monitoring specifications, according to Whitney. In addition, the company is evaluating whether to expand to system to monitor other environmental-critical areas of their buildings.