Online Automated Dissolution Systems

Integrated Fluidic Circuitry and Closed-Loop Sampling

The online system utilizes a sophisticated fluidic circuit that connects each dissolution vessel directly to a dedicated flow cell in the spectrophotometer. Technically, this can be configured as a "closed-loop" system, where the media is returned to the vessel after analysis, or an "open-loop" system. The closed-loop approach is particularly advantageous as it maintains a constant volume within the vessel without requiring complex media replacement calculations, ensuring that the dissolution process adheres strictly to the validated method parameters.

High-Precision Multi-Channel Pumping Systems

To facilitate the transfer of media, Pharma Test integrates high-precision multi-channel pumps, such as peristaltic or piston pumps. These pumps are designed to deliver consistent flow rates across all channels simultaneously. Technical precision in flow control is vital to ensure that the residence time in the flow cells is uniform and that no air bubbles are introduced into the optical path, which would otherwise interfere with the spectrophotometric absorbance readings.

Real-Time Data Acquisition and Profile Visualization

A primary technical advantage of the online configuration is the ability to perform real-time data acquisition. As the media circulates through the spectrophotometer, the software records absorbance at specified wavelengths and immediately converts this into concentration data. This allows for the immediate visualization of the dissolution profile, enabling laboratory personnel to identify anomalies or rapid release characteristics as they happen, rather than waiting for post-test analysis.

Automated Wavelength Scanning and Multi-Component Analysis

The integrated software allows for advanced spectroscopic techniques, including automated wavelength scanning and multi-component analysis. This is technically significant for dosage forms containing more than one active pharmaceutical ingredient (API) or for formulations where excipients might interfere with the primary absorbance peak. The system can be programmed to account for these interferences, ensuring that the calculated drug release is accurate and specific to the analyte of interest.

Seamless Software Integration and Instrument Control

The entire online system is controlled by a central software platform that manages both the dissolution bath and the spectrophotometer. This technical integration ensures that sampling intervals are perfectly synchronized with the analyzer’s measurement cycles. The software provides a unified interface for method development, data processing, and reporting, which simplifies the validation process and ensures that all components of the system operate as a single, cohesive unit.

Automated Filtration and Line Priming

Before reaching the spectrophotometer, the dissolution media passes through automated filtration stages, typically tip filters on the sampling probes. This technical step is crucial to remove undissolved particles that could cause light scattering or block the narrow channels of the flow cells. Furthermore, the system performs automated line priming and rinsing cycles to ensure that the fluid path is equilibrated with the current sample, preventing carryover and ensuring measurement accuracy.

Compliance with Data Integrity and 21 CFR Part 11

Online automated systems are designed to meet the highest standards of data integrity. Every action, from the start of the dissolution test to the final calculation, is logged in a secure database. Technical features such as multi-level user access, electronic signatures, and immutable audit trails ensure that the system is fully compliant with 21 CFR Part 11 and other global regulatory requirements, making the data generated suitable for submission to health authorities.

Enhanced Laboratory Productivity and Efficiency

By automating the most time-consuming aspects of dissolution testing—sampling and analysis—the online system significantly increases laboratory productivity. Technicians are freed from the repetitive tasks of manual sampling and sample preparation for HPLC or UV. This technical automation allows for higher throughput, as multiple tests can be run with minimal supervision, and the immediate availability of results accelerates the decision-making process in formulation development and quality control.

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