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Products » Pharmaceutical Testing Equipment » Dissolution Testers » Fully Automated RoboDis II

Fully Automated 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.

 

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.

 

Specifications

  • Fully automated dissolution testing for up to 10 batches in standard version

  • 100% USP/EP compliant

  • System is 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 to 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 run-time

  • Fraction collection into glass tubes, Peltier-cooled HPLC vials

  • Automatic online controlled variable cleaning procedure

  • Integrated system suitability tests for the 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 bi-directional connection to various IT-systems integrated

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