HPLC On-/Offline Dissolution Testers –  System Overview

The ERWEKA Dissolution HPLC On-/Offline System is the semi-automatic solution for 100% USP/EP/JP compliant dissolution testing with HPLC online analysis. Up to 5 of 8 dissolution steps can be automated by combining one of our highly qualified DT 950 series dissolution testers with devices for CTC sampling and online HPLC chromatography. The entire system is controlled by our Disso.NET software.

For filtrations up to 0.22 µm, our automated filter changer AFC 825 can be used in combination with our maintenance-free PVP pump. In addition, to a precise and simple control of the entire system, Disso.NET offers an accurate recording of the whole test process, from the automatic recording of the sampling time up to the recording of the temperature and rotation speed in each vessel (= Documentation of all system operations, audit trail).

Download the Online System Spec Sheet here.

Connectivity

HPLC Online connection or chromatograph systems

Our on-/offline dissolution testing system offers connection to equipment of all main manufacturers of HPLC systems, including Shimadzu, Agilent and Waters as well as the possibility of a connection to different chromatograph systems like Empower (Waters) or Cerity (Agilent).

UV-VIS Online Connection

In addition to the HPLC connection the ERWEKA on-/offline dissolution system offers the possibility to include a UV-VIS spectrophotometer (Shimadzu, Jena or Agilent) into the closed-loop sample withdrawal system, either between the sample transfer pump and the PEEK flow-through vial block or the PEEK flow-through vial block and the return to the dissolution tester.

Therefore the ERWEKA on-/offline dissolution system can be used as:

• sample collection device (max. 324 samples; incl. sample tempering)
• a HPLC online system in combination with virtually any brand of HPLC device
• an UV-VIS online system (incl. virtual dilution by various path length with optimized flow-through cuvettes)

Connect Two Dissolution Testers

The ERWEKA on-/offline dissolution system allows to connect two ERWEKA dissolution testers via two individual sample transfer pumps to one autosampler with two embedded PEEK flow-through vial blocks (no cross contamination).

Either none, one or both of the dissolution testers, in addition to the HPLC online system, can be fitted with a UV-VIS spectrophotometer inside the close-loop sampling system.

Disso.Net Software – Control of Your Dissolution Tester System

The ERWEKA Disso.net software is the perfect 21 CFR Part 11 compliant companion to our dissolution tester systems. The software offers support of all methods manageable with the ERWEKA DT dissolution testers as well as the automated RoboDis II.

Disso.net helps you with standard dissolution jobs, handles qualifying tasks and provides control over each single function and connected device (e.g. dissolution tester or UV/VIS spectrophotometer). Our audit trail generates a detailed protocol recording all events and time. The software includes an easy to handle method editor for highest repeatability. After finishing the dissolution test, Disso.net creates reports with your corporate logo as PDF-file or exports your results (e.g. as XML-file).

Video Monitoring

An automated system runs without user observation. In order to determinate the cause in case of unexpected results, ERWEKA offers video monitoring of  six dissolution vessels of one or two connected dissolution testers. The video monitoring allows recording of each test-run in combination with real-time overlapping dissolution profile to identify disturbances such as coning etc. and to get the visual impression of 24 hours in 2 minutes. The video monitoring is a very powerful tool for method development as well for troubleshooting.