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        Fully Automated Dissolution System

        Small footprint, great results.

        Disso.NET

        Three complete semi-automatic dissolution testers including media preparation and vessel cleaning - this is the amount of floor space you can save with a RoboDis II 10-batch system, which has a footprint of no more than 2x1 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.


        Our Innovation

        Our Innovation

        RoboDis II - unique & fully automated.

        RoboDis II is the only parallel-working, fully automated dissolution test system currently on the market. All stages of the dissolution processes are computer-controlled and therefore carried out entirely without user intervention. The key element of the fully automatic system is the Disso.NET software developed by ERWEKA, which handles all system functions, including the precise movement of the robot arm, control of the analytic devices, data processing and full documentation.

        In the standard configuration, RoboDis II tests up to 10 batches in accordance with USP methods 1 (Basket) or 2 (Paddle). The parallel sampling approach enables very short cycle times for recording of detailed drug release profiles to be selected by the user. Integrated System Suitability Tests (SST) and video monitoring ensure a high degree of reliability. Like all ERWEKA products, RoboDis II is fully USP/EP/JP compliant.



        Versatile Applications

        Advanced dissolution system with a broad range of functions.

        • Productivity booster

          RoboDis II for quality control

          Boost your productivity

          • High planned productivity with 10, 20 or 40 batches
          • Testing non-stop: high product throughput
          • Parallel action
          • Robotic precision & fault monitoring
          • Space-saving footprint
        • Flexible specialist

          RoboDis II in R&D

          A flexible specialist.

          • Handling of multiple dosage forms
          • Versatile filtering options
          • pH change: half change and optional full change
          • Various options for connecting to analytic devices
          • 6 reference standards for quick testing


        Not smarter, but more reliable

        Innovative RoboDis II safety systems.

        • Safety Systems

          RoboDis II Safety Systems

          RoboDis II performs routine tasks more precisely than any human operator – but without a human operator all its powerful fully automatic features would be worth nothing. It is the human operator who defines the test methods, checks results for plausibility and interprets the data obtained. To enable him or her to focus on these tasks, we have equipped RoboDis II with a number of safety features.

        • System Suitability Test

          System Suitability Tests

          In each individual process step, RoboDis II self-checks by means of integrated System Suitability Tests (SSTs). Several built-in light barriers validate the steps performed by Robo Dis II, thus preventing false starts.

        • Documentation

          Full Documentation

          Each step of the test is logged in accordance with the industrial standard 21 CFR Part 11. This will enable you to check, for example, whether RoboDis II actually did test all 40 batches completely over the weekend.

        • High-quality system components

          High-Quality System Components

          RoboDis II is built with tried-and-tested, reliable system components, amongst them, e.g., ERWEKA’s maintenance-free PVP pump and the robot arm made by the internationally renowned pneumatics manufacturer Festo. The use of premium components guarantees maximum precision and lowest downtimes.

        • Video Recording

          Video Recording

          RoboDis II optionally records the entire dissolution process with six integrated video cameras. This allows validating the entire test upon completion, or overlaying the dissolution curve on a time-lapse video recording. Thanks to the LED light strip the water bath can be illuminated at night, allowing 24 hour video recording without the need for external lighting.


        Disso.NET

        Disso.NET

        The key element in the RoboDis II system.

        RoboDis II is controlled fully automatically by its integral controller equipped with the Disso.NET software. Designed by ERWEKA specially for the purpose, the Disso.NET-Software constitutes the key element of the RoboDis II system:

        A user-friendly editor enables the required dissolution test methods to be defined and started. Disso.NET then manages all steps of the dissolution process from media preparation through to analysis. The software also controls the precise movement of the robot arm and the connected analytical devices. Disso.NET logs all test results and times, and automatically creates an audit trail. Upon completion of the test, the software generates extensive reports and enables export of all test results. In addition, the software controls the System Suitability Tests and the video recording functions.


        Overview

        Real 24/7 testing

        Human-error proof.

        Thanks to the newly developed LED light strip, the water bath can also be illuminated at night and thus allows 24 hours video recording without the need of external lights. The LED light bar is very energy efficient and offers the perfect brightness for our new gigabit Ethernet camera system. The RoboDis II supports up to six of these new cameras which are simply connected to the controlling PC, using the already established Ethernet network connection inside the RoboDis II.


        New 40 Batch

        New 40 batch solution

        Perfect for high volume testing.

        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 offers a 40 batch filter holder. In combination with the LED Light bar, the RoboDis II is now able to continually test samples 24 hours/7 days a week.


        The robotic arm

        The robotic arm

        Central to RoboDis IIs testing procedure is our advanced, pneumatic robot arm. This arm assembles all samples, adds and removes filters and is even responsible for filling and cleaning of the vessels, saving the operators tremendous amounts of time for doing those repetitive tasks.
        Sample magazine for 10, 20 or 40 batches

        Sample magazine for 10, 20 or 40 batches

        In the 40-batch version, RoboDis II enables true 24/7 testing and is capable of handling 40 batches without human intervention.
        pH changes

        pH changes

        Optional pH measurement permits pH changes according to USP Method A (half change) and Method B (full change).
        Filter magazine

        Filter magazine

        Poroplast filters are fitted fully automatically for each test by the robot arm.
        Built-in media preparation

        Built-in media preparation

        The built-in media preparation feature fully automatically prepares the medium for the testing procedures. Media preparation is configured through the Disso.NET software, with RoboDis II taking care of all other steps.
        Online UV-Vis analysis or HPLC

        Online UV-Vis analysis or HPLC

        RobDis II supports integrated online UV-Vis or HPLC analytic devices. Samples are withdrawn fully automatically and transferred to the analytics devices.
        Seven test vessels

        Seven test vessels

        Seven USP-compliant test vessels in the RoboDis II system support testing in R&E and in quality control. In quality control, for example, six samples may be compared to a reference sample. Alternatively, seven different samples can be tested in parallel for Research & Development.
        Precise piston pump

        Precise piston pump

        The highly precise piston pump with ceramic heads is virtually maintenance free and ideally suited to the high sample volumes handled by RoboDis II.
        Baskets, paddles & sinkers

        Baskets, paddles & sinkers

        RoboDis II supports the use of both paddles (USP 2) and baskets (USP 1), both of which can be exchanged by the user. Moreover, it supports the use of sinkers measuring up to 34 mm. Dropping and removal of sinkers take place fully automatically with the sinker tool provided.
        Video recording

        Video recording

        RoboDis II is equipped with 6 video cameras and a LED light strip. The water bath can be easily illuminated and the new video capturing capabilities can be used without the need for external lights. In addition, video recording of the dissolution process in time-lapse mode is possible.
        • The robotic arm

          The robotic arm

          Central to RoboDis IIs testing procedure is our advanced, pneumatic robot arm. This arm assembles all samples, adds and removes filters and is even responsible for filling and cleaning of the vessels, saving the operators tremendous amounts of time for doing those repetitive tasks.
        • Sample magazine for 10, 20 or 40 batches

          Sample magazine for 10, 20 or 40 batches

          In the 40-batch version, RoboDis II enables true 24/7 testing and is capable of handling 40 batches without human intervention.
        • pH changes

          pH changes

          Optional pH measurement permits pH changes according to USP Method A (half change) and Method B (full change).
        • Filter magazine

          Filter magazine

          Poroplast filters are fitted fully automatically for each test by the robot arm.
        • Built-in media preparation

          Built-in media preparation

          The built-in media preparation feature fully automatically prepares the medium for the testing procedures. Media preparation is configured through the Disso.NET software, with RoboDis II taking care of all other steps.
        • Online UV-Vis analysis or HPLC

          Online UV-Vis analysis or HPLC

          RobDis II supports integrated online UV-Vis or HPLC analytic devices. Samples are withdrawn fully automatically and transferred to the analytics devices.
        • Seven test vessels

          Seven test vessels

          Seven USP-compliant test vessels in the RoboDis II system support testing in R&E and in quality control. In quality control, for example, six samples may be compared to a reference sample. Alternatively, seven different samples can be tested in parallel for Research & Development.
        • Precise piston pump

          Precise piston pump

          The highly precise piston pump with ceramic heads is virtually maintenance free and ideally suited to the high sample volumes handled by RoboDis II.
        • Baskets, paddles & sinkers

          Baskets, paddles & sinkers

          RoboDis II supports the use of both paddles (USP 2) and baskets (USP 1), both of which can be exchanged by the user. Moreover, it supports the use of sinkers measuring up to 34 mm. Dropping and removal of sinkers take place fully automatically with the sinker tool provided.
        • Video recording

          Video recording

          RoboDis II is equipped with 6 video cameras and a LED light strip. The water bath can be easily illuminated and the new video capturing capabilities can be used without the need for external lights. In addition, video recording of the dissolution process in time-lapse mode is possible.


          360° Service

          Premium service for a premium product.

          Installation

          Installation

          One-week professional installation and commissioning of your RoboDis II through our certified ERWEKA technicians.

          Qualification

          Qualification

          We offer the proper performance of the necessary qualifications for your RoboDis II.

          Preventive Maintenance

          Preventive Maintenance

          Preventive half-yearly maintenance services ensure a long lifespan for your RoboDis II.

          Device trainings

          Device trainings

          Hands-on courses and training provide profound user knowledge.

          24h RoboDis hotline

          24h RoboDis hotline

          Personal advice and direct clarification of questions via our 24h RoboDis hotline.

          Fast repair service

          Fast repair service

          Reliable, quick repair service through our highly qualified service employees at ERWEKA or your site.

          Service contracts

          Service contracts

          We offer customized service contracts with which you can ensure the durability and high precision of your testing equipment and maintain control of your operating costs for years to come.

          Highly-qualified customer support

          Highly-qualified customer support

          We have a powerful and global service network of highly skilled and experienced service employees.


          Features and options

          More facts.

          • General

            General features

            Massive throughput for maximum time reduction.

            • Fully automated dissolution testing for up to 10 batches in standard versions
            • Fully automated dissolution testing for up to 40 batches
            • 100 % USP/EP/JP compliant
            • Complete system control by a reliable industrial robot arm
            • Parallel sampling approach of the next release medium
            • Controlled by validated Disso.NET software based on Microsoft SQL server (most advanced dissolution software)
            • Integrated, flexible bidirectional interface to various IT systems
          • Methods

            Methods

            Versatile methods and full support for pH changes according to USP.

            • USP methods 1 and 2 - basket and paddle
            • pH changes according USP method A (half change) and USP method B (full change)
            • pH measuring in each (!) vessel
            • Handling of pH sensor by robot arm
            • Documentation of all data obtained including calibration of pH meter
            • Parallel tablet drop/li>
            • Handling of sinkers up to 34 mm & "japanese sinkers"
            • High accuracy and reliability of process steps
            • Support pellets and granulates
            • Mounting of baskets by robot arm
            • Used baskets are automatically dropped in cleaning container
            • Handling of up to 6 different media/concentrates
          • Media & Cleaning

            Media & cleaning

            Massive time reduction thanks to integrated media preparation and cleaning routines.

            • Automatic media preparation and supply
            • Mobile tank for 120 litres of medium with optional stirrer
            • Supports up to 6 (SUPAC) different media or media concentrates per start
            • Preheating and vacuum degassing in accordance with USP guidelines
            • Dosing with gravimetrically controlled precise piston pump
            • Parallel preparation of the next medium during the dissolution test run
            • Supports handling of foaming media
            • Parallel cleaning performed automatically
            • Number of cleaning steps can be chosen
            • Result of the cleaning process is checked (SST)
            • Contaminated media can be separated
            • Integrated water stop
          • Sample collection, filtration & analysis

            Sample collection, filtration & analysis

            Broad support for different kind of analysis devices.

            • USP compliant standard filtration with 1 μm to 20 μm inline filters
            • Additional filtration with flat membrane filters (≥ 0.22 μm)
            • Support of different brands of photometers and HPLC systems (e. g. Agilent, Waters, Shimadzu, Perkin Elmer, Hitachi, Analytik Jena)
            • Closed loop sampling system for UV online and/or HPLC online/UPLC online available
            • Parallel sampling with valve-free ceramic piston pump PVP, virtually maintenance-free
            • Sampling time points independent from HPLC runtime
            • Fraction collection into glass tubes or peltier-cooled HPLC vials
          • 24/7 Testing

            Real 24/7 testing

            With 40 batches and video recording.

            • 10, 20 or 40 batches
            • LED light strip illuminates water bath and allows use of new video capturing capabilities without the need for external lights
            • Perfect brightness for recording at night without the need to illuminate the complete tab
            • Video recording of dissolution process in time-lapse mode
            • Energy efficient
            • Support for formulation and dissolution method development
            • Gigabit Ethernet camera connection - high bandwidth and easy integration into RoboDis II local network
          • Disso.NET

            Disso.NET software

            Full system control.

            • 21 CFR Part 11 compliant Disso.NET software suite according to GAMP 5
            • Interactive communication between RoboDis II and analytical method
            • User-defined reports via "Crystal Reports"
            • Online control of rpm and temperature
            • Bidirectional LIMS interface via XML


          Gallery

          Get an impression of the ERWEKA RoboDis II.


          Download

          Our brochure.

          RoboDis II Brochure

          RoboDis II Brochure

          Download our brochure for more in-depth information.

          Download

           

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