Symyx Technologies has announced that a Clinical Trial Phase One group within a pharmaceutical company is using its Powdernium workstation to dispense API and excipients into capsules.
The group has standardised upon the workstation for automating pure drug active pharmaceutical ingredients (API) dispensing and binary blending with excipient into capsules.
The manual API dispensing and excipient blending techniques traditionally used by the Clinical Trial Phase One group were slow, inaccurate and prone to cross-contamination.
Driven by the need to reduce the time and costs associated with producing a drug product or formulation for Clinical Trial Phase One studies, Symyx Technologies was tasked with establishing an accurate process for automatically dispensing and blending the powders.
The workstation solution needed to handle capsules of varying sizes and be able to handle a range of API and excipients without cross-contamination.
Accurate capsule filling, particularly when dosing milligram amounts of powder, is critical for many pharmaceutical products.
Symyx was able to provide the customer with a CFR Part11 compliant workstation solution for dispensing API and excipients into capsules.
Using separate dispensing heads, and a tray for capsule management, the Powdernium workstation has eliminated cross-contamination.
Designed to run unattended at all times, the implementation of four Powdernium capsule-filling workstations has enabled the Clinical Trials Phase One group to achieve improvements in the throughput and accuracy of API dispensing and homogeneous blending together with an overall reduction in operating costs.
Combining accurate balance weighing, a software algorithm and GMP-compliant dispensing heads, Powdernium technology enables laboratories to precisely dispense and record the transferred weight of a wide range of materials from low density to free-flowing, cohesive, micronised materials and more.
The Powdernium workstation enables precise, traceable and reproducible dispensing of sub-milligram (0.05mg) to gram quantities of materials into a range of containers including capsules, bottles, vials, tubes, microplates, reactor blocks and crucibles.
Automation including robust XY and two Z-axis controls allows the Powdernium workstation to run unattended operations, speeding development, reducing costs and improving consistency.
The Powdernium Easy-Dose software provides real-time data display and record storage (supports CFR Part 11 compliance) about the dispensing cycle, including batch conditions and operating parameters.
Using optimisation algorithms the Powdernium workstation is able to dynamically monitor and automatically control any variability in powder properties during the filling process.
