Sotax – AT MD Fully Automated UV-Vis On/Off-line
Fully automated from media preparation to data reporting Basket and paddle methods as well as sinkers including Japanese sinkers Up to 8 unattended batches UV-Vis on/off-line analysis on the fly
AT MD Fully Automated
Fully automated from media preparation to data reporting
Basket and paddle methods as well as sinkers including Japanese sinkers
Up to 8 unattended batches
UV-Vis on/off-line analysis on the fly
100% visibility and CenterView™ video monitoring
The innovative circular design of the dissolution bath opens up a new dimension of observation possibilities for R&D visualization and OOS troubleshooting. Understanding the release characteristics of formulations requires full visibility of samples during the dissolution test. Depending on your observation needs, the circular AT bath allows visual observation of each vessel from the outside and additionally from the inside using video monitoring. To view the behavior of samples from the bottom, an optional mirrored base plate is available.
The unique CenterView™ design provides perfect visualization and video recording of release processes in each vessel. Located in the center of the dissolution bath, all cameras can be adjusted and controlled for height and focal distance. For optimum visibility, indirect light is integrated into this space-saving design.
Precise temperature control and easy handling & cleaning
The innovative circular design of the dissolution bath sets new standards for precise, quick and easy operation. Like its predecessor models, the AT dissolution bath has been optimized for ideal water circulation to ensure extremely high temperature homogeneity during the test. From fast filling and draining of the water bath with quick-connector, self-priming circulation pump, to motorized lift function, all handling and cleaning processes of the AT have been optimized for simple and fast execution. When adding test medium or removing vessels, the vertically lifted shaft drive provides excellent accessibility during all change-over and cleaning processes.
Compliance by design
The AT dissolution apparatus fully complies with all harmonized Pharmacopeia requirements and features “built-in” compliance without any adjustment. The proven SOTAX AutoCompliance™ concept with fixed shaft height and vessel positioning guarantees 100% compliance without requiring time-consuming adjustments by the operator. For fast change-overs, quick-lock systems and a vertical bath closing mechanism (manual or motorized) provide for simple handling processes.
Auto-centering vessels: Time-consuming vessel set-up is unknown with the AT’s auto-centering quick-lock system. Locking rings, which are fixed on the base plate, guarantee highly accurate vessel centering and allow analysts to insert or remove vessels within seconds. Each vessel is certified and closed with an individual cover limiting evaporation.
Fixed shaft height: Proven to have the lowest wobble ratings in the industry, the AT incorporates the same shaft design as previous SOTAX dissolution baths. All shafts are self-centering and no adjustment of shaft height is required – maintaining the highest level of precision while making changeovers fast and simple.
Fully documented qualification: The AT has been designed to facilitate highly accurate mechanical calibration anytime. Using the innovative Mechanical Qualification Device (MQD), all required procedures and measurements can be easily performed and results are automatically documented according to the current FDA guidelines on enhanced mechanical qualification.
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.
Media Preparation and Delivery
Up to 5 different media (including concentrates and media with surfactants) per sequence of 8 tests can be automatically heated, degassed, and dispensed into the vessels prior to the test. The system can easily change media types between tests. The gravimetric delivery system assures accurate and reproducible media dispensing. Various fill volumes in different vessels – from 250 mL to 1,000 mL – are possible and are therefore ideal for DOE studies. During a basket method, media can be replaced automatically for two stage dissolution testing.
Dosage Form Introduction
For paddle testing, dosage forms are stored in an 8-position carousel on the top of each vessel – protected from the media vapors. Inlets allow for all types of dosage forms: all tablet sizes (introduction diameter: 18 mm), sinkers. Almost any magnetic sinker larger than 15 mm in its smallest dimension (including magnetic Japanese sinkers) can be used with the system. Dosage form introduction for basket and paddle methods is automated and simultaneous. For basket methods,a robotic arm sequentially attaches all the baskets containing the dosage form on their respective shaft.
The AT MD system uses automated cannulas to simultaneously withdraw samples. All sampling probes are equipped with temperature probes recording a temperature from each vessel when sampling. For accurate and reproducible sampling on all channels and at each time point, the AT MD has 6 automated piston pumps – for filtered sample transfer. The integrated filter station automates the change of 25 mm syringe filters on all 6 channels at each run, each sampling point, or at media change. Samples are collected and stored in tubes or closed vials and can be analyzed by either a UV-Vis or LC device.
Data Analysis & Reporting
SOTAX systems offer sample collection, storage, and UV-Vis integration. These options can be combined in a variety of analytical configurations and re-configured should needs change.
The MD software is 21 CFR, Part 11 compliant, controlling all aspects of data capture and analysis with customized reporting and exporting. It allows data export to ELN/LIMS, user-group configuration and report configuration. MDsoft is a flexible software package designed to fulfill R&D and QC requirements.
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.
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.