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

Dissolution Testers

 

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.Dissolution Testers


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.

Dissolution Testers


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.