AT Dissolution Bath
Built on the success of preceding SOTAX dissolution systems, the AT can be flexibly configured for USP 1,2,5,6 dissolution methods.
Its unique design combines robust quality components with state-of-the-art technology to guarantee reproducible testing conditions, day after day.
Depending on the required automation level, the AT can be flexibly extended with additional Xtend™ modules – making method transfer for increased throughput requirements easier than ever.
CP Piston Pump Module
Simultaneous Sample Withdrawal
The accuracy of sample transfer from the dissolution apparatus to the sample manager and/or analytical device largely depends on the accuracy of the pump used and on its ability to push or pull liquids through the filters.
As sample transfer occurs simultaneously on all channels, any pump used must contain 6-8 equivalent modules.
CP Piston Pump Module
The CP Piston Pump Module is the ideal choice for automated systems as it can be combined with the FS Filter Station, SAM Sample Manager or C61x Fraction Collector, and a UV-Vis spectrophotometer. It can also be used to perform media addition. To reduce the overall footprint, the CP Module is fully stackable on the other Xtend™ Modules. The ceramic piston head design is completely maintenance-free and does not require any priming. Fully controlled by either the EasyTouch™ user interface or WinSOTAXplus Dissolution Software, the powerful CP Module can pull and push through filters with a porosity down to 0.2 microns.
SAM Sample Manager (Off-line / On-line)
Universal and Efficient Sample Management
Workload increase or method changes often call for maximum flexibility and scalable sample management – in addition to safe and reproducible collection & storage.
The SAM Sample Manager can be used either as a simple fraction collector to collect and store samples in standardized vials and tubes, or as an advanced sample manager to add or replace media. Controlled by the EasyTouch™ user interface or by WinSOTAXplus Dissolution Software, the SAM will fit with all dissolution methods – independent of the automation level chosen.
The SAM module can be stacked with the CP Piston Pump module and/or the FS Filter Station to reduce overall system footprint.
Available in three versions (S/M/L), the module allows vertical storage of samples in up to 3 levels. Its capacity can also be extended horizontally for double-automated systems or for an increased number of time points.
Optional Components for Your Configuration
MPS Media Preparation Station
Accurate media preparation plays a vital role in all subsequent processes. The MPS Media Preparation Station allows operators to degas, heat, and dispense the exact volume of dissolution media required for each method.
Degassing at the USP and FDA recommended levels, the MPS is a mobile unit assisting in bringing 10 – 20 L of degassed and heated media to your dissolution system. By inserting the dispensing nozzle into individual vessels, precise and gravimetrically validated dispensing of media at 1’500 mL per minute without re-aeration is achieved. Once dispensing has been completed, the MPS can be simply connected to the next DI water inlet to start its automated cleaning routine – while the dissolution test runs.
Syringe Pump Module
Containing 6-8 precision syringes, the module is integrated into the SAM dispensing head for off-line dissolution systems. This simple and space-saving design allows simultaneous transfer of samples through filters with a porosity down to 1 micron into test tubes or LC vials. For seamless integration, the syringe pump module can be controlled directly via the EasyTouch™ user interface or alternatively by WinSOTAXplus Dissolution Software.
FS Filter Station
Filtering dissolution samples prior to analysis is essential to the accuracy of dissolution results. The Xtend™ Dissolution Line can be operated with different membranes and filters of various porosities.
Membrane filters: The 25 mm membrane filters can be used with sampling probes, automated cannulas, and HollowShaft™. Integration directly into the suction head makes these filters both economical and user friendly.
Syringe Filters: The 25 mm syringe filters offer 100% flexibility as they can be universally used on disposable syringes, sampling probes, stationary cannulas, automated cannulas, HollowShaft™, CP Modules, and FS Filter Stations. Ideal for simplified method transfer, they can be used on all automation levels. During method development in R&D, the variety of porosities allow the user to find the filter required for analytical finish. In QC, the robustness and strength of this filter housing guarantees consistency of the filtration surface. Syringe filters are Luer-locked and therefore robust and easy to use.
FS Filter Station: To avoid saturation and clogging of syringe filters, it may be necessary to exchange them after each sampling point. The FS Filter Station automatically exchanges filters and can hold up to 424 filters for filtering through 6, 7, or 8 channels. Robust and fast in operation, the module guarantees liquid-tight circulation at each time point. To reduce overall system footprint, it can be stacked with other Xtend™ Modules.
WinSOTAXplus Advanced Dissolution Software
Professional Data Management
Developed in close cooperation with industry experts and system users, theWinSOTAXplus software is based on a deep understanding of today's dissolution user requirements and allows implementation of a fully 21 CFR, Part 11 compliant data management system for all XtendTM configurations and automation levels.
The WinSOTAXplus software offers user-friendly control of your complete system. Whether used stand-alone or in a networked environment, the modern client-server architecture can be flexibly implemented for different needs. From data capture to analysis with customized reporting and exporting features - the software fulfills all R&D and QC requirements.
For advanced data management, specific user-group definition and bi-directional data transfer to ELN/LIMS are available. Simple batch analysis alongside assisted data review is possible with customized reports and method creation including product specifications. Spend less time on compliance paperwork with highlighted pass/fail reports alongside enhanced temperature, rpm, and pH recording throughout the test. Comprehensive standard monitoring and customized system suitability requirements are stored and executed per product to ensure proper SOP execution.