The ERWEKA Dissolution HPLC On-/ Offline System is the semi-automated solution for 100% USP / EP / JP compliant dissolution testing with HPLC online analysis. Up to 5 out of 8 dissolution steps can be automated by combining one of our highly qualified dissolution testers of the DT 950 or DT 9510 series 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 automatic filter changer AFC 825 can be used in combination with our maintenance-free PVP pump. In addition to precise and simple control of the entire system, Disso.NET provides an accurate record of the entire test process, from the automatic recording of the sampling time to the recording of the temperature and rotation speed in each vessel (= documentation of all system processes, Audit Trail).
Semi-Automatic Dissolution Test With HPLC Analysis
A Simple Way to HPLC Analysis
After the dissolution test* with the DT 950 and double filtration with the PVP 820 pump and the AFC 825, the medium is transferred to the HPLC sampler. There, it is first filled into a transfer block (PEEK block) and then distributed into appropriate vials. If required, the samples can be diluted for immediate analysis or cooled and temporarily stored against UV radiation for later analysis.
The HPLC analysis starts as soon as a sample is filled into the sampler’s HPLC valve and a trigger signal is sent from Disso.NET to the HPLC device. The analysis and evaluation is carried out using the analysis software of the respective HPLC manufacturer on a separate PC. As the analysis times of the samples are defined in advance via the Disso.NET software, the sampler steadily passes the samples on to the HPLC device (even after the release has been completed). This means that the dissolution test with HPLC analysis can be carried out automatically and without an operator (e.g. even at night). After the HPLC analysis, the results are displayed on a separate PC.
Proven ERWEKA Quality Throughout Components
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Dissolution Tester DT 950The dissolution tester of the DT 950 series is 100% compliant with USP methods 1, 2, 5 and 6 and can be operated in both high-head and low-head mode. |
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PVP 820 PumpThe test medium is transported to the automated filter changer AFC 825 by the practically maintenance-free piston pump, with high precision and pressure over eight channels. In conjunction with the AFC 825, it enables filtration with up to 0.22 μm flat membrane filters. |
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Disso.NETThe ERWEKA Disso.NET software is the perfect companion for ERWEKA’s semi-automated dissolution HPLC On-/ Offline systems. The software takes full control and provides support for all test methods that can be used with the dissolution system with HPLC analysis. Disso.NET helps with standard dissolution jobs, handles qualification tasks and provides control over every single function of the connected devices (e.g. DT, PVP and auto sampler). In addition, the software includes an easy-to-use method editor for convenient programming of dissolution methods (for maximum safety in the GMP environment). The Audit Trail also creates detailed logs of all events and time periods, allowing changes to be tracked at any time. After completion of the dissolution test, Disso.NET creates comprehensive reports (as PDF files or printouts) and can export all results in various formats (e.g. as XML files). |
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HPLC SamplerWith the HPLC sampler, samples can be reliably and flexibly collected and stored for subsequent HPLC analysis. It excels with its mechanical precision and compact design. The open and modular instrument design also allows individual components to be replaced within a short time. If required, the collected samples can be diluted or stored temporarily, cooled and UV-protected for later analysis. The HPLC sampler automatically detects the correct position of the injection syringe and thus ensures fast, reproducible sample injection into the vials. That way, possible mixing of the individual samples is avoided. The autosampler is easily controlled by our ERWEKA Disso.NET software. |
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Automatic Filter Changer AFC 825We recommend the implementation of a second filtration to avoid contamination or damage of the HPLC column due to particles, thus improving the accuracy of the HPLC analysis. In combination with the high-precision, practically maintenance-free PVP pump, we offer an additional device: the automated filter changer AFC 825. The AFC 825 enables the automatic exchange of the used membrane filters (e. g. 0.45 μm, 1 μm) after each sampling or each test run. In addition, the media replacement can be conducted via the integrated bypass. As most of the filters are uni-directional – i.e. media is pumped in only one direction – the bypass prevents the media from being pressed back through the used membrane filters, thus avoiding the risk of filter damage. The automated filter changer features a magazine with eight positions for membrane filters (max. 8×25 filters) and comes in two configurations:
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Our HPLC Analysis Systems Comprehensive Configuration
- HPLC On-/ Offline Dissolution System with DT 950, PVP 820 pump and AFC 825 (recommended)
- HPLC On-/Offline Dissolution System with DT 950, IPC 8 Pump and AFC 825
- Optional: Connection of 2 DTs (including 2 x PVPs or IPCs) to an HPLC sampler with 2 transfer blocks (PEEK blocks)
- Optional spectrophotometers: Shimadzu, Agilent, Waters
- IQ / OQ / PV documents and services available
