RoboDis II – Fully Automated Dissolution Testers

RoboDis II – The Future of Dissolution Testers

The RoboDis II range of dissolution testers are 100% USP/EP compliant dissolution systems, capable of fully automated dissolution testing of up to 10 batches with USP method 1 (basket) or 2 (paddle). The high-performance system is managed via the 21 CFR Part 11 compliant Disso.Net software. The software controls all functions including the precise robot arm movement as well as all analytical devices including data processing.

Integrated system suitability tests (SST) ensure reliability and easy control. Due to a parallel sampling approach, very short cycle times for measuring profiles can be realised.

The amount of floor space you can save with a RoboDis II 10-batch system is massive. Three complete semi-automatic dissolution testers including media preparation and vessel cleaning can be replaced. Furthermore, the RoboDiss II has a footprint of no more than 2×1 m. With the RoboDis II+ the complete dissolution process can be automated. This way, fully automated testing, including setup, media preparation and automated cleaning process is possible.

Download the RoboDiss Spec Sheet here.

RoboDiss II Highlights

Fully automated dissolution testers for up to 10 batches
USP method 1 and 2 – basket and paddle
100% USP/EP/JP compliant
pH change in accordance with USP method A (half change) and USP method B (full change), pH measuring in each vessel
Parallel sampling approach
Handling of Japanese sinkers
Handling of up to 6 different media (concentrates and/or ready prepared) independently controlled by load cell
Vacuum degassing of the pre-heated dissolution media in accordance with USP
Filters precisely fitted by robot hand
Filtration with flat membrane filtres (≥ 0,22 µm) supported
Several analytical methods supported
Support of several photometers and HPLC-systems
Sampling time points independent of HPLC runtime
Integrated system suitability tests for filling procedure, analytical method, system cleaning and test parameters (e.g. rotation speed, temperature)
Video monitoring in time-lapse mode with overlaid real time dissolution curve
Flexible bidirectional connection to various integrated IT systems
24/7 dissolution testing and documentation with the USB 3.0 cameras and LED light bar

Analytical Methods

Fraction collection
HPLC – online connection
Buffered HPLC – online connection
UV/VIS – online connection with flow-through cells
Combination of all of the above
Combined HPLC and UV/VIS online connection

24/7 Dissolution Testing

Thanks to the newly developed LED light bar, the water bath can be illuminated at night and allows video capturing without the need of external lights. The LED light bar is energy efficient and offers the perfect brightness for our new USB 3.0 camera system. RoboDis II supports up to 6 of these new cameras which are simply connected to the controlling PC via a USB 3.0 hub.

High Volume Dissolution Testing – New 40 Batch Solution

Our newly developed 40 batch magazine for RoboDis II allows fully automated testing of up to 40 batches of samples. In addition to the 40 batch sample holder, the RoboDis II also gains a 40 batch filter holder. In combination with the LED Light bar, RoboDis II is now able to continually test samples 24/7.

Technical Details

Fully automated dissolution testers for up to 10 batches in standard version
100% USP/EP compliant
System fully controlled by a reliable industrial robot arm
Parallel sampling approach> to decrease the sampling time point for profile measuring
USP method 1 and 2 – basket and paddle
pH change according USP method A (half chance)
pH measuring in each (!) vessel
Handling of Japanese sinkers
Handling of up to 6 different medias (concentrates and/or ready prepared)
Vacuum degassing of the pre-heated dissolution media according to USP
Media filling by precise piston pump with independent weight controlling
Media temperature measurement in each (!) vessel
Standard filtration with 1 µm to 20 µm inline filters
Filtration with flat membrane filters (≥ 0,22 µm)
Support of different brands of photometer and HPLC-systems (e.g. Agilent, Waters, Shimadzu, Perkin Elmer, Hitachi, Analytik Jena)
Sampling time points independent from HPLC runtime
Fraction collection into glass tubes, Peltier-cooled HPLC vials
Automatic online controlled variable cleaning procedure
Integrated system suitability tests for filling procedure analytical method, system cleaning and experimental parameters (e.g. rotational speed, temperature)
Controlled by validated Disso.Net software based on Microsoft SQL server (most advanced software for dissolution testers)
Video monitoring in time lapse mode with overlaid real time dissolution curve
Flexible bidirectional connection to various IT-systems integrated

RoboDis II Options

Fully automated dissolution testers for up to 40 batches
Closed loop sampling system for UV online and/or HPLC online/UPLC online available
Medium selector is available which allows using various kinds of media or media concentrates.
For further information and options please contact us.