The Future of Dissolution RoboDis II

The RoboDis II is a 100% USP/EP compliant dissolution system for 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.nIntegrated 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.n

The Future of Dissolution Highlights

• Fully automated dissolution testing 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), 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 IT systems inte-grated
• 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

Real 24/7 Testing

Real
24/7 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 offfers the perfect brightness for our new USB 3.0 camera system. RoboDis II supports up to 6 of these new cameras wich are simply connected to the controlling PC via a USB 3.0 hub.

High volume 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 testing 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 dissolution software)
• Video monitoring in time lapse mode with overlaid real time dissolution curve
• Flexible bidirectional connection to various IT-systems integrated