- The Evolution in Automated Dissolution Testing -

With RoboDis® ERWEKA sets the benchmark in the high-end of automated dissolution testing.

The system has been developed in close cooperation with Bayer and therefore reflects state-of-the-art operational know how acquired in over 15 years of process optimization and auto-mation in method development and quality control laboratories.

RoboDis® performs up to 20 test-runs automatically. To increase the throughput the system comprises two 8-station Dissolution Testers which are completely handled by the integrated Robot. As a consequence system performance is significantly improved compared to conventional automated dissolution testers.

RoboDis® combines the flexibility of a Robot (USP methods 1, 2 and 5; media change according to USP methods “A” and “B”; insert and removal of Japan Sinkers etc.) with the speed of an automated Dissolution Tester (simultaneous operation of volumetric media filling, tablet drop and sample withdrawal).

Analysis can be performed either by Fibre Optics, UV-VIS or HPLC. 

SYSTEM DESCRIPTION

2-in-1

RoboDis® includes two 8-station Dissolution Testers which are operated by an industrial 3-axis Robot. Based on the configuration with 2 Dissolution Testers the throughput in comparison with other automated dissolution testers is significantly increased.


Vessel Filling

In its standard configuration RoboDis® offers volumetric filling of the vessels.

The actual filling level of each vessel is controlled and documented by control weighing. Optionally a medium selector is available, which allows for the use of various kinds of media.

To increase the throughput of the system simultaneous vessel filling is available in combination with the ERWEKA MultiPrep.


pH change

RoboDis ® supports the automated pH change according USP method “A” (half-change) and method “B” (full change).


Cleaning

On completion of the test-run the media is removed from the vessels by vacuum (no valves in the vessel). Remaining tablet debris (matrix) can be dissolved by a cleaning solution or be removed by increasing the vacuum. After use the complete system is rinsed with hot water or a combination of cleaning solution and water.

Used media can be separated into standard waste water and contaminated waste water based on a valve system.


Methods

The RoboDis® is designed for the fully automated performance of up to 20 dissolution tests according to the latest USP/EP/JP requirements. It supports the following methods and processes:

• Performance of tests with USP Apparatus 1, 2 and 5
• Automated change of method from apparatus 1 to 2 and vice versa
• USP compliant Basket start routine
• Use of “Japan Sinkers”
  

Filtration

Filtration can be performed by either Tip or Membrane Filters (min. 045 µm), dependent on the Analysis system used.


Analytics

RoboDis® offers maximum flexibility concerning the analytical method applied as well as full visual supervision of the dissolution process:

• UV-VIS “in-vitro” measuring based on fibre optics (no Multiplexer required due to sequential measuring)
• Online measuring based on UV-VIS and/or HPLC analysis
• Sampling into a fraction collector for offline operations
• Measuring of calibration and control standards in case of online operations
  

System Control

• 21 CFR Part 11 compliant Windows based software package
• Online control of rpm and temperature in each individual vessel and in the bath
  

Video Controlling

As an additional feature RoboDis® offers video analysis of the dissolution process in time-lapse mode with overlapping real-time dissolution curve to identify disturbances such as coning etc.

Compliance

RoboDis® is compliant with all other relevant regulatory standards in the pharmaceutical industry:

• 21 CFR Part 11
• GAMP (current edition)
• CGMP (FDA)
• GMP Guidelines of the EU
• EMC directive according to EN 61010
• Guidelines of US Pharmaceutical Manufacturer’s Association (PMA)concerning the qualification and computer validation of equipment