Sotax – Dissolution Tester

Highly flexible fully automated self-cleaning dissolution tester with online UV-Vis analysis and offline sample collection for multiple test runs.

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Overview

Features

Specifications

ATF Xtend™ Offline

Fully automated self-cleaning dissolution tester to perform a series of unattended test runs.

ATS Xtend™ Offline

Dissolution tester automatically withdraw, filter, and collect samples in tubes, capped LC vials, or well plates.

AT Xtend™ Manual

Easy-to-operate manual dissolution tester with advanced monitoring options.

Key Features

Sampling – World’s most simple & repeatable manual sampling process with HollowShaft™
Easy – User-friendly touch screen operation with operator-prompts for staggered start
Flexible – Perform dissolution tests for all USP 1/2/5/6 methods and other non-compendial methods
Data – Intuitive and fast method creation with version control and advanced user administration
Temperature – Automatically protocol individual vessel temperatures before pulling samples
Monitoring – Record dissolution behaviour per vessel with integrated video monitoring
Automation-ready – Turn your bath into a semi-automated dissolution tester anytime by adding Xtend™ modules

Technical Specifications

AT Dissolution Apparatus
Weight	56 kg (1 L bath) 57 kg (2 L bath)
W x D x H (mm)	560 x 710 x 940 (1 L bath) 560 x 710 x 1040 (2 L bath)
Environmental conditions	Temperature: 15 °C to 30 °C, Relative humidity: 10 % and 75 %
Noise emission	< 70 dB (A)
Power supply	115-230 V +/- 10 %
Power consumption	1100 VA
Software compatibility	WinSOTAXplus
Tube dimensions	Inside Ø 1.5 mm or 0.8mm Outside Ø 3.0 mm
Interfaces	USB, Ethernet, CAN, RS 232, D-sub
Shaft materials	Stainless steel, gold-coated, teflon-coated
Compliance	The AT dissolution apparatus complies with all pharmacopeia requirements.

Available Models

Key Features

Sampling – World’s most simple & repeatable manual sampling process with HollowShaft™
Easy – User-friendly touch screen operation with operator-prompts for staggered start
Flexible – Perform dissolution tests for all USP 1/2/5/6 methods and other non-compendial methods
Data – Intuitive and fast method creation with version control and advanced user administration
Temperature – Automatically protocol individual vessel temperatures before pulling samples
Monitoring – Record dissolution behaviour per vessel with integrated video monitoring
Automation-ready – Turn your bath into a semi-automated dissolution tester anytime by adding Xtend™ modules

Highlights

Repeatable sampling

Manual sampling within designated time slots can be challenging. Your AT Xtend™dissolution tester offers different possibilities for sampling – including the proven HollowShaft™ technology. Operators simply attach syringes to luer-lock connectors on the suction head and pull samples directly through the drive shaft. The sampling position inside the vessel is fixed and 100% repeatable without creating any undesired hydrodynamic effects.

Guided procedures

An icon-based, user-friendly EasyTouch™ interface assists the operator in executing tasks. Automatic user prompts guide dosage form introduction for staggered test start. Once the dissolution test is running, an alert with audible signal announces upcoming timepoints ahead of time. For sample withdrawal, the operator is once again guided through the staggered sampling procedure.

See what’s happening

The circular bath design provides excellent observation possibilities during your dissolution runs. Developed with video monitoring in mind, it allows for a complete and unobstructed full vessel view from both outside and inside the water bath. Optional CenterView™ video monitoring and in-vessel temperature measuring with AutoLift™ further add to the protocolling capabilities of your manual dissolution tester.

Automation-ready

The manual AT Xtend™ is ready for automation. You can turn your manual bath into a semi-automated system anytime – simply add other Xtend™ modules. Whether you would like to take samples automatically, collect withdrawn samples in capped LC vials, or want to integrate a UV-Vis spectrophotometer – the AT Xtend™ is ready whenever you are.

Compliance by Design

The AT Xtend™ is compliant by design – and helps to ensure that your manual dissolution tests are performed in accordance with Pharmacopeia regulations. Low wobble ratings, fixed shaft height, and self-centering vessels allow for fast and trouble-free change-overs without any adjustments by operators.

Key Features

Sampling – Always take samples the same way at reproducible withdrawal positions
Offline – Collect samples in glass tubes, capped LC vials, or HPLC / UPLC wellplates
Methods – Program multiple timepoints and automatically replace withdrawn sampling volumes
Fast – Timepoint intervals of less than 1 minute possible with powerful piston pump
Modified release- Automatically change filters at defined timepoints for your DR / MR methods
Fine filtration – Push through filters with a minimum porosity of 0.2 microns for offline HPLC / UPLC analysis
Flexible – Maintain full flexibility without dedicating your dissolution tester to an analytical device

Highlights

Reproducible sampling

The ATS Xtend™ Offline automates essential steps of your dissolution test – making them highly repeatable. Samples are simultaneously taken from 6-8 vessels, filtered, and collected in tubes, capped LC vials, or wellplates. Standardization of the sampling position, pulling force, volume, timing, and filtration reduces potential sources of variability and makes your testing process more efficient.

Multi-purpose media selector

Perform one-touch sample line cleaning on completion of a test. Simply connect a water tank to the multi-purpose selector of your Xtend™ dissolution bath and start the automated tube-flushing routine. Up to 3 additional sources can be connected to automatically replace withdrawn sampling volumes during dissolution tests with multiple timepoints or to execute pH changes by adding media.

Highly effective filtration

Xtend™ dissolution line is built on flexible sampling and filtration. Mimic existing environments when replacing old dissolution testers to ensure comparability of results. Use tip filters or sieves for pre-filtration, disc filters in the suction head, or standard syringe filters. Require fine filtration for your analytical finish? No problem – the powerful CP piston pump can push through filters down to 0.2 microns and also handles foaming media with surfactants.

Easy to use

Operators simply select a method on the EasyTouch™ user interface and press START to initiate the dissolution test. In full compliance with the FDA data integrity guidance on segregation of roles, only authorized personnel like supervisors or administrators can modify existing methods or create new recipes. To share methods between multiple systems, the ATS Xtend™ can be conveniently networked with data management software.

Monitoring dissolution

Use AutoLift™ to automatically protocol temperatures inside all 6-8 vessels before test start, when taking samples, or at any point during the test in your dissolution tester. Additionally, you can record dissolution behavior inside each vessel with CenterView™ to document tha

Key Features

100% Unattended – Run a series of dissolution tests without any operator action required.
100% Traceable – Automatically execute and record all steps from media preparation to system cleaning.
100% Repeatable – Perform tests the same way every time – from vessel filling to sampling, filtration, and washing routines.
Media – Automatically prepare, heat, and degas media to fill vessels, to replace withdrawn sample volumes, and to perform pH changes.
Fine filtration – High-precision piston pumps can push through filters down to 0.2 microns for trouble-free HPLC / UPLC analysis.
Clean – No need to remove vessels anymore. The self-cleaning system automatically empties all vessels and performs a washing routine between test runs.
Collect – Collect samples in test tubes, capped LC vials, or wellplates from up to 60 timepoints.

Highlights

True Automation

Repeatable operation of simple laborious steps is the heart of the fully automated ATF Xtend™ dissolution system. Execute and record all steps from media preparation to vessel filling including gravimetric verification of vessel volumes, sampling & filtration, and cleaning of the entire system. Test execution is virtually identical to a semi-automated dissolution tester – adding traceable vessel filling and robust system cleaning performed automatically between test runs.

Fill, Rinse, Repeat

Medium preparation the efficient way – let your system do it for you. The integrated MP-F module allows preparation & degassing of media using different recipes and sources. Prepare media in-line with concentrate using your house DI source or connect different media types for automated preparation. Pull a vacuum on your dissolution media at temperature for complete & cost-efficient deaeration or degas with helium sparging if required.

Keep on running

Make your tests continuous – or prepare a new series of tests while the ATF Xtend™ dissolution tester is running. Whether you automate dissolution DOE in R&D or routine testing in quality control (QC) departments, SmartAdd™ allows flexible interaction and avoids downtime. Simply exchange complete tablet magazines or add new samples to a running sequence.

Sample, Collect, Repeat

Workload increases or method changes call for maximum flexibility and scalable sample management – in addition to safe and reproducible collection and storage. The ATF Xtend™ with integrated SAM autosampler allows collection of dissolution samples in glass tubes, capped vials, or HPLC / UPLC wellplates from up to 60 timepoints. Highly effective flow-through rack cooling ensures that collected samples are safely stored under controlled environmental conditions.

Compliance by Design

The ATF Xtend™ dissolution tester complies with all harmonized Pharmacopeia requirements as stated in USP, Ph.Eur., and others. Proven AutoCompliance™ with repeatable sampling positions, fixed shaft height and vessel centering guarantees 100% compliance without requiring time-consuming adjustments by the operator. State-of-the-art data management with q-doc^® software ensures data integrity and allows implementation of a fully 21 CFR part 11 compliant system.