On-/Offline Dissolution System
A high degree of automation and flexibility is offered by the half-automated on-/offline dissolution testers. The system is controlled via the fully validated ERWEKA Disso.net software and offers automated dissolution testing, integrated UV-Vis analysis and sample collection into HPLC vials or glass tubes for reference samples or later HPLC analysis.
UV/Vis Online Connection
The ERWEKA on-/offline dissolution system offers the possibility to include a UV/Vis spectrophotometer (Shimadzu, Analytic Jena or Agilent) into the sample withdrawal system.
Therefore ERWEKA on-/offline dissolution testers can be used as:
- sample collection device (max. 324 samples; incl. sample tempering), and
- an UV-VIS online system (incl. virtual dilution by various path length with optimized flow-through cuvettes).
An automated system runs without user observation. In order to determinate the cause in case of unexpected results, ERWEKA offers a video recording system where six dissolution vessels are monitored. The video system 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.
ERWEKA FRL Sample Collector
ERWEKA’s Sample Collector FRL is offered with up to 26 rows for extended release formulation testing.
- Needles available in stainless steel or titanium for sensitive APIs
- Special procedure for handling of foaming media
- Automated flush routine between sampling intervals
- Movable trays provide easy exchange of different racks
- Different racks available for glass tubes or HPLC vials
- Handling of septa-sealed HPLC vials
- Easy access to sample tubes
- Easy to clean
With the standard ERWEKA 8-channel peristaltic pump IPC 8 the sample is taken from the dissolution tester vessel via a USP/EP compliant sampling station with stainless steel sampling tubes and is then injected to the flow-through cells of the spectrophotometer. After analysis, the sample is transferred back to the test vessel.
The Disso.net software not only offers a compact analytical report (default report with all relevant data), but also shows method data, calibration data and raw data.
Disso.Net Software – Dissolution Testers That Offer Full Control
The ERWEKA Disso.net software is the perfect 21 CFR Part 11 compliant companion to our dissolution 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).
12 Test stations
DT 1412 dissolution testers with 12 test stations can also be configured as an UV/VIS On-/Offline system. This configuration has a ASS-14 auto sampling station on top of the tester and an IPC-16 pump connects to either an Shimadzu or Jena Specord UV/Vis with two cuvette changers and and FRL 624-2 sample collector, all managed via PC and ERWEKA Disso.net software.
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:||DT 950 with auto sampling station ASS-8|
|Pump:||IPC-8 channel peristaltic pump. The pump tubings are made of Verderprene to prevent the absorption. The pump is connected via an serial RS 232 interface to the PC running Disso.net software.|
|Sample Collection:||FRL 624 for 6 channels|
|Spectrophotometers:||Analytic Jena Specord 210/8
|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 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|