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Offline Automated Dissolution Systems
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Include a dissolution bath, a pump and a fraction collector
Pharma Test Offline Automated Dissolution Systems
Pharma Test offline automated dissolution systems are technically engineered to streamline the complex process of drug release testing by automating sample withdrawal, filtration, and storage. These systems bridge the gap between manual testing and fully integrated online analysis by collecting samples at precisely programmed time intervals and depositing them into sealed vials or microtiter plates for subsequent analysis via HPLC or UV-Vis.
The technical core of the offline configuration involves the seamless integration of a dissolution bath with an automated sampling station and a fraction collector. This setup allows for unattended operation, as the system manages the lowering of sampling probes, the priming of lines, and the exact volume withdrawal for each time point. Advanced filtration options are integrated directly into the fluid path to remove undissolved particles immediately, ensuring that the dissolution process is "quenched" at the exact moment of sampling.
High-Precision Volumetric Sampling Mechanisms
The offline automated system utilizes sophisticated pumping technologies, such as multi-channel syringe pumps or peristaltic pumps, to ensure volumetric accuracy. These pumps are technically calibrated to withdraw precise volumes from the dissolution vessels at programmed intervals. Syringe pumps, in particular, offer superior precision and the ability to handle various media viscosities, ensuring that the volume removed for analysis is consistent across all vessels and all time points throughout the test duration.
Automated Probe Handling and Hydrodynamic Integrity
To minimize interference with the dissolution process, the system features automated sampling probes that only enter the media during the actual sampling event. These probes are lowered to the USP-specified sampling zone and retracted immediately after the required volume is collected. This technical approach prevents the constant presence of a probe from creating turbulent flow or affecting the dissolution rate of the dosage form, thereby maintaining the standardized hydrodynamic conditions required for regulatory compliance.
Integrated Sample Filtration and Quenching
Immediate filtration is critical to stop the dissolution process once the sample is removed from the vessel. Pharma Test offline systems incorporate various filtration options, including tip filters on the probes and integrated disc filters within the fluid path. This ensures that any undissolved drug particles are separated from the liquid phase instantly, providing a true representation of the dissolved concentration at the specific sampling time and preventing further dissolution during storage.
Advanced Fraction Collection and Storage
The fraction collector is a central component of the offline system, designed to handle various types of collection vessels, such as HPLC vials or 96-well plates. The collector is technically synchronized with the sampling pump to ensure that each sample is deposited into the correct position without cross-contamination. Many collectors also offer cooling options to maintain sample stability and automated sealing features to prevent evaporation of the dissolution media before analysis.
Media Replacement and Mass Balance Maintenance
When significant volumes are withdrawn during a dissolution test, it is often necessary to replace the removed media to maintain a constant volume. Pharma Test offline systems can be configured with a media replacement module that automatically adds pre-heated fresh media back into the vessels. This technical capability ensures that the mass balance and the concentration gradients within the dissolution vessel remain within the limits defined by the validated analytical method.
Fluid Path Inertness and Carryover Prevention
The materials used in the fluid path, including tubing and valves, are selected for their chemical inertness to prevent the adsorption of active pharmaceutical ingredients (APIs). Furthermore, the systems utilize automated "rinse and prime" cycles between sampling points. This technical process flushes the lines with fresh media or solvent to ensure that no residue from the previous sample remains, effectively eliminating carryover and ensuring the purity of subsequent samples.
Software Control and 21 CFR Part 11 Compliance
The operation of the offline automated system is managed by dedicated software that provides a comprehensive interface for method development and execution. The software is technically designed to meet 21 CFR Part 11 requirements, including secure audit trails, user access levels, and electronic signatures. This ensures that all automated actions, from pump speeds to collection times, are recorded and traceable, which is essential for quality control in a regulated environment.
System Modularity and Analytical Flexibility
The technical architecture of these systems is inherently modular, allowing for easy adaptation to different dissolution methods (USP 1, 2, 5, and 6). The offline configuration is particularly flexible as it does not require a direct physical link to an analytical instrument like a spectrophotometer. This allows the collected samples to be analyzed at a later time or moved to a different laboratory, making it an ideal solution for facilities managing high sample volumes and multiple analytical workflows.
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