Switzerland-based Symyx Technologies Europe has installed a Powdernium workstation that automates pure drug active pharmaceutical ingredients (API) dispensing and binary blending with excipient into capsules in a Clinical Trial Phase 1 group at an unnamed pharmaceutical company.
The manual API dispensing and excipient blending techniques traditionally used by the group were said to be slow, inaccurate and prone to cross-contamination. Symyx Technologies was tasked with establishing an accurate process for automatically dispensing and blending the powders. The workstation needed to handle capsules of varying sizes and a range of API and excipients without cross-contamination.
Symyx provided a CFR Part11 compliant workstation with separate dispensing heads and a tray for capsule management. The implementation of four Powdernium capsule filling workstations capable of working around the clock has enabled the Clinical Trials Phase 1 group to achieve significant improvements in the throughput and accuracy of API dispensing and homogeneous blending, as well as an overall reduction in operating costs.
The Powdernium workstation enables precise, traceable and reproducible dispensing of sub-milligram (0.05mg) to gram quantities of materials into capsules, bottles, vials, tubes, microplates, reactor blocks and crucibles. Fault tolerant and adaptive, the intelligent Powdernium Easy-Dose software provides real-time data display and record storage about the dispensing cycle, including batch conditions and operating parameters. Using optimisation algorithms the workstation is said to dynamically monitor and automatically control any variability in powder properties during the filling process.