As with the AT MD, the AT 70smart fully automated dissolution system also automates the complete dissolution process – from preparation to cleaning. Several tests of the same or different products can be executed directly after each other – without requiring any user action. Compared to the AT MD, the AT 70smart provides higher throughput, allowing the batching of up to 15 unattended dissolution tests.
Choose Your Analytical Configuration
Off-line
The dissolution bath can be flexibly combined with additional modules for automated sample collection and storage.
Scalable collection and storage of samples into standardized tubes or vials
Sample protection from temperature and light degradation
Sample dilution
Use of vertical space to reduce footprint
UV-Vis On-line
The dissolution bath can be flexibly combined with additional modules including UV-Vis integration.
Automated UV-Vis measurements for real time results
Single dissolution software for raw data acquisition and flexible calculation
Automates the manual sample transfer which can be a source of manipulation error
Allows unattended dissolution run, results being stored and saved automatically
UV-Vis On/Off-line
The dissolution bath can be flexibly combined with additional modules for automated sample collection, storage, and UV-Vis integration.
Flexibility: fraction collection and/or UV-Vis measurements for sample archival or UV-Vis/LC immediate comparison
AT 70smart Fully Automated
UV-Vis On/Off-line
The industry benchmark for complete fully automated USP 1, 2 Dissolution
Increases productivity automating the testing of up to 40 batches of 6 samples without any user interaction
Automates all steps from media/change preparation to sample collection, UV-Vis measurement, data reporting/exporting and system cleaning
Driven by 21 CFR, Part 11 compliant ready WinSOTAXplus Advanced Dissolution Software
Use of any major brands of UV-Vis spectrophotometers including the SOTAX Specord Plus models
Customized solutions for specific dosage form introduction
AT 70smart Dissolution Bath Design
The core of the AT 70smart is the AT 7smart, a stand-alone bath, which has been adapted to implement full automation and allow simplified throughput, scale-up, and dissolution method transfer.
Hemispheric valves in the vessels allow simultaneous full or partial media changes within individual basket and paddle methods. Furthermore, the valves guarantee fast removal of sinkers, pellet cartridges, and undissolved dosage form components from the vessels at the end of the test followed by rapid cleaning.
The AT 70smart uses the Hollow Shaft™ system, which eliminates probe-sampling effects due to hydro-dynamic disturbances. This design assures a reproducible sample withdrawal at a compliant sampling height.
It also simplifies media half change and media addition in order to change the pH.
The SOTAX AutoCompliance™ (compliance by design) concept with fixed shaft height and vessel autocentering, ensures reproducible and compliant vessel-shaft assembly without any manual adjustment.
Flexibility maximized - suited for all dosage forms
Large inlet dimensions provide for a wide variety of tablet and sinker types to be introduced manually or automatically. From standard tablets to capsules with large sinkers – the dissolution bath is capable of handling virtually all dosage forms. Samples are protected from media before test start. As the inlets are closed during the test, media evaporation is prevented.
UV-Vis analysis on the fly
The dissolution software used in the UV-Vis on-line systems gives the lab scientist dissolution results on the fly. From a mono- or multi-wavelength absorbance measurement - compared to a standard value stored or measured - concentration and % dissolved are immediately calculated, stored and reported.
Off-line analysis
Workload increase or method changes often call for maximum flexibility and modular and scalable sample management devices. They also require safe and reproducible collection and storing as well as logical programming. An off-line configuration offers simplicity and flexibility as the samples once stored in glass tubes or LC vials can be conveyed to any kind of analytical device in all kind laboratory set-ups.
LC On-Line
The dissolution bath can be flexibly combined with additional modules LC integration.
Automated LC injections for real time results
Automates the manual sample transfer which can be a source of manipulation error
Allows back up sampling
Space saving integrated system
Sample flow controlled by WinSOTAXplus
Compatible with any existing LC software
LC On/Off-Line
The dissolution bath can be flexibly combined with additional modules for automated sample collection, storage, and LC integration.
Automated LC injections for real time results
Automates the manual sample transfer which can be a source of manipulation error
Allows back up sampling
Space saving integrated system
Sample flow controlled by WinSOTAXplus
Compatible with any existing LC software
Components
AT 70smart Dissolution Bath
The AT 70smart holds up to 15 batches of tablets. An integrated tank and pump prepares and fills the vessels with media prior to the dissolution test. A tablet magazine automatically, and simultaneously drops samples into each vessel, and temperature and pH are monitored throughout the run in the reference vessel. The CP 7-35 pump and the FS 7 filter station, integrated in the AT 70smart, withdraw, filter, and deliver samples to the SAM sample manager. Using power washing jets and pressured air for drying, the AT 70smart completes each run with a programmable cleaning cycle.
UV-Vis Sample Analysis and Reporting
UV-Vis analysis being the final step of the dissolution process, SOTAX dissolution systems allow integration of different analytical processes and combine results in a powerful data management software.
The WinSOTAXplus Dissolution Software allows full control of all common UV-Vis spectrophotometers. Dissolution samples can be withdrawn, filtered, conveyed, and measured in “Absorbance” at single- or multiwavelength in flow through cuvettes. The readings are calculated, reported, and stored in a 21 CFR, Part 11 compliant SQL database.
Seamless integration with Specord Plus®
SOTAX also offers its own UV-Vis solution: the Specord Plus 200 or Specord Plus 210 UV-Vis spectrophotometers are fully integrated in the dissolution systems. Both devices exceed Pharmacopeia requirements and have a true double beam with reference compensation. Using two symmetrical 8-position cell changers, they are ideal for double on-line and double on-/off-line system configurations. As a standard, the Specord Plus series comes with a 10 year warranty on optics.
C61x Fraction Collectors
The C61x generation of fraction collectors has been used worldwide in R&D and QC for semi- and fully automated dissolution systems. They allow collection of dissolution samples in 15 mL glass tubes and LC vials. The C61x can be configured with a piercing valve allowing for collection of samples in closed vials. The fraction collectors are simple, robust, firmware- and software-driven. They can store dissolution samples from 7 or 14 channels in 1 or 2 racks (double systems) of 13, 29 rows.
Optional C61x features include: racks with rinsing position, customized racks, Peltier-cooling, and additional valve for media replacement. Longer fraction collectors are available for fully automated systems.
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.
Optional Components for Your Configuration
BS60 Basket Station
The BS 60 basket station is used for basket tests (USP 1). It holds 10 batches of baskets, transports them accurately between basket station and AT 70smart dissolution bath before and after the dissolution test, and handles the used baskets after the test.
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