Fully Automated Dissolution System
Small footprint, great results.
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
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.
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RoboDis II+ for Quality control
The productivity booster
- Planned productivity to suit your requirements with 10 or 40 batches
- Testing non-stop: high sample volumes - 40 batches
- Parallel action
- Robotic precision & fault monitoring
- Space-saving footprint
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RoboDis II+ in R&D
The flexible specialist
- Multiple dosage forms
- Flexible filtering options
- pH change: half change and optional full change
- Various options for connecting to analytic devices
- Six reference standards
Not smarter, but more reliable
Innovative RoboDis II+ safety systems.
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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.
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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.
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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.
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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.
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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
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.
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+.
Highly productive - 40 batch solution
Perfect for high volume testing.
Our 40 batch magazine for RoboDis II+ allows fully automated dissolution test runs 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.
360° Service
Premium service for a premium product.
Installation
One-week professional installation and commissioning of your RoboDis II+ through our certified ERWEKA technicians.
Qualification
We offer the proper performance of the necessary qualifications for your RoboDis II+.
Preventive Maintenance
Preventive half-yearly maintenance services ensure a long lifespan for your RoboDis II+.
Device trainings
Hands-on courses and training provide profound user knowledge.
24h RoboDis hotline
Personal advice and direct clarification of questions via our 24h RoboDis hotline.
Fast repair service
Reliable, quick repair service through our highly qualified service employees at ERWEKA or your site.
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
We have a powerful and global service network of highly skilled and experienced service employees.
Features and options
More facts.
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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
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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
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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
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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
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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
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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
- User management with Active Directory
Gallery
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RoboDis II+ Brochure
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