Metrics Contract Services, the contract pharmaceutical development and manufacturing division of Mayne Pharma, has invested in additional equipment to enhance capacity in drug delivery. A Korsch XM-12 Bilayer Tablet Press and a Top Spray Fluidization system for the Glatt GPCG-120 PRO will further provide capacity and efficiency improvements in meeting increasing client demand for potent oral solid dose (OSD) product processing.
 
Metrics’ new Korsch XM-12 is a state-of-the-art small-scale press with hard-wall isolation/containment for potent product processing and is a strategic addition for Metrics’ formulation development team. The tablet press is designed for both single layer and bi-layer tablet production and has the added flexibility of both B and D quick changeout turrets for rapid changeover.
 
The Glatt 120 Top Spray Fluidization system enables top spray coating, the surface coating, which ensures improved product handling or storage stability to protect against moisture, oxygen or light. The spray liquid is sprayed from above onto the fluidized particles.
 
Along with the new top spray system, Metrics added a new vacuum transfer system that can transfer the API and excipient directly to the fluid bed dryer. Once the final product is ready, it can be transferred fully contained. The process also leaves “zero API in wastewater.” 
 
“Both of these new technologies add capacity in our development/clinical and commercial sectors, allowing us to develop more complex dosage forms, explore enhanced drug delivery options, and meet demand for larger production orders,” said Brad Gold, vice president of pharmaceutical development, Metrics. “These additions are part of Metrics Contract Services’ commitment to continuous improvement on behalf of our customers.”
 
In preparation for using the Korsch XM-12, Metrics’ scientists and manufacturing team underwent training alongside Korsch factory technicians in parallel with qualification and validation that was performed by Metrics’ qualification/validation team experts.
 
“All were required to meet both industry standards and the standards set by Metrics validation and quality team leaders,” said Gold. “The training targeted pharmaceutical development operators and scientists, technical transfer staff and maintenance staff. Both bilayer and single layer modules were challenged as well as instruction on changeovers, cleaning and containment testing.”
 
According to Gold, the XM-12 has the built-in technology to maintain consistent precision output with very little operator interaction after critical settings are put into place.