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).
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).
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.
- Video recording of the dissolution process in time-lapse mode
- Up to 6 cameras supported
- Overlapping real-time dissolution curve
- Support for formulation and dissolution method development
- USB 3.0 cameras with USB 3.0 Hub – connect only one cable
- Updated low-light capabilities
Depending on your requirements and needed system setup, a broad range of options is offered. Please contact our sales representative for more information.
|Dissolution Tester:||One or two ERWEKA DT 950 series dissolution tester|
|Pumps:||8-Channel Peristaltic Pump (IPC 8). Pump tubings are made of Verderprene (similar to fluoropolymer) to prevent the absorption previously associated with peristaltic pumps and PVC tubing. Via the serial RS 232 interface the pump is controlled from the external PC<Optional:
Valve-free piston pump PVP for high precision and high throughput, maintenance free
|Sample Collection:||for HPLC: CTC sample collector with up to 324 HPLC vials (optional cooled)|
|Spectrophotometers:||ERWEKA SPM or Shimadzu 1800 including 8 position cell changer, dissolution kit, additional tubing/connectors and upgraded validated HPLC online dissolution software for online UV-VIS analysis incl. protocols for Shimadzu, Jena Specord 205 or Agilent 8453, including 8 position cell changer, dissolution kit, additional tubing/connectors and upgraded validated HADs dissolution software for Online UV-VIS analysis incl. protocols|
|System Control:||ERWEKA Disso.net Software: Windows based, CFR 21/11 compliant. ERWEKA driver to connect and control ERWEKA DT dissolution testers|
|System Tubing||System tubing PTFE|
|Cells:||Cuvettes for UV-VIS Spectrophotometers with fluoropolymer tubing (0.8 mm o.d.) and screw fittings are available with various path length (1 mm, 2 mm, 5 mm, 10 mm)|
|IQ/OQ/PV:||IQ/OQ/PV documents are available, IQ/OQ/PV service is available|
|Video||Video recording of dissolution test of 6 vessels|