JCB Laboratories, experts in sterile compounded solutions, has set the standard for environmental monitoring with the installation of a continuous cleanroom monitoring system from Lighthouse Worldwide Solutions. The pharmacy's latest improvement is a proactive approach to federal legislation that will bring new regulatory oversight to the compounding industry.
"Quality and safety have always been our top priorities, and we are constantly reinvesting in process and quality improvements," said Brian Williamson, Pharm.D, President and Chief Executive Officer, JCB Laboratories. "The Lighthouse monitoring system is a significant step forward in that effort."
The Lighthouse monitoring solution includes devices that continuously measure differential pressure, temperature and relative humidity in the cleanroom, as well as temperatures of all drug storage areas, dry heat ovens, incubators and refrigerators. This is the largest and most comprehensive monitoring solution installed by Lighthouse in a compounding pharmacy in the nation.
By continuously monitoring differential pressure, compounding lab staff will be quickly alerted to possible air contamination. The system includes alarm lighting and sound that will visibly and audibly alert staff if a sensor detects an approaching "out-of-range" threshold. This allows the pharmacy to correct issues before they become problems.
"The Lighthouse monitoring system will help guard against contamination and better protect the cleanroom environment," Williamson said. "We really appreciated the insightful advice and expertise of the Lighthouse team in helping JCB choose a system and components that contribute to ensuring a sterile product for our customers and their patients."
The recently passed federal compounding legislation resulted from last year's tragedy at the New England Compounding Center and subsequent concerns about the quality of compounding pharmacies. The final rules, which the FDA will use to regulate compounding facilities, are expected to be more stringent than the current USP 797 regulation.