In early 2009, Metrics Inc. will open a state-of-the-art dedicated potent and cytotoxic drug development facility.
As part of Metrics’ recent $18-million expansion, the new dedicated facility will provide total engineered containment of pharmaceutical processes through customized hard-wall isolation technologies.
Because of these technologies, Metrics’ has eliminated any need for the use of powered air purifying respirators (PAPRs) in its new potent facility. Equipment and change parts are dedicated exclusively to potent and cytotoxic use, and containment is achieved at levels approximately 30 nanograms per cubic meter of room air.
All of which makes Metrics’ dedicated potent and cytotoxic facility unique within its industry. “According to our internal research, Metrics’ new facility has raised the industry bar in providing potent handling capabilities for clients,” said Phil Hodges, president. “Given the enormous growth in demand for potent handling capabilities, I am confident that our facility will attract clients because of the safety, security and reliability Metrics offers for client studies and employees alike.”
Metrics Inc. (metricsinc.com), headquartered in Greenville, N.C., provides quality pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.
Thanks to its recent 47,000-square-foot facility addition, Metrics now offers four new analytical laboratories, bringing to seven the total number of analytical laboratories. The labs are fully operational, validated and ready for projects.
Also as part of its recent expansion, Metrics provides stability storage with environmental specialties chambers complete with redundant mechanical systems and strictly limited personnel access. The company brought antibiotic assay and sterility testing online, enhancing its ability to offer full microbiological support of sterile products.
Metrics’ new potent and cytotoxic facility will feature two processing rooms that come complete with independent entry double airlocks, independent decontamination showers and exit airlocks, independent equipment airlocks, and access to an dedicated washroom. It is designed for one-way flow of material, personnel and equipment.
A dedicated air handler will bring in 100-percent outside air with HEPA-in and HEPA-out filtering at the rate of 11,000-cubic-feet per minute and 25 air changes per hour. There are pass throughs for the export of product and waste as well as dedicated equipment storage.
“We’ve increased our capacity to safely work with more potent active pharmaceutical ingredients by reducing exposure to 30 nanograms per cubic meter, making us a leader within our industry,” Hodges said.
After every campaign, Metrics staff will conduct comprehensive health-based cleaning verification of shared surface areas. The isolated equipment that is permanently housed inside the potent facility includes:
• Fluid Energy Jet-O-Mizer micronizer;
• Fitzpatrick Fitz L1A;
• Globe Pharma Mexi-Blend (0.5 to 16 quart);
• Vector TFC Lab micro roller compactor;
• Fluid Air Pharm X High Shear Granulator with 1L, 2L, 4L and 8L bowls;
• Vector FLM1 fluid bed dryer / top-spray granulator;
• Quardro Comil U-5 model;
• Riva 10-station instrumented Picolla tablet press;
• Capsule filling devices;
• Tablet film coater.
Because of its $18-million facility expansion, Metrics is increasing staff, adding at least 50 pharmaceutical scientists and technicians, among them industry veterans with the experience to oversee projects from conception through completion.
Metrics is one of the fastest-growing contract pharmaceutical development laboratories in the United States today.