Dissolution HPLC On-/Offline System
with HPLC analysis
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).
Components
Proven ERWEKA quality throughout the whole system
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Dissolution Tester DT 950
The dissolution tester of the DT 950 series is 100% compliant to USP methods 1, 2, 5 and 6 and can be operated in high-head as well as low-head mode. -
PVP 820 Pump
The test medium is transported with high precision and pressure via eight channels to the automated filter changer AFC 825 by the practically maintenance-free piston pump. In conjunction with the AFC 825, it enables a filtration with up to 0.22 μm flat membrane filters. -
Double filtration with AFC 825
In case of a HPLC analysis it is recommended to perform a double filtration, to avoid contamination or damage of the HPLC column due to particles, thus improving the accuracy of the HPLC analysis. The high-precision, practically maintenance-free PVP pump in combination with the automated filter changer are particularly suitable for this purpose. -
Disso.NET Software
Our advanced dissolution software solution Disso.NET takes over full control of the dissolution system and offers extensive functions, enhanced user management and diverse data export options (e.g. LIMS connection). -
HPLC sample collection & analysis
With the HPLC sampler the samples can be collected (and cooled) and injected automatically in the HPLC system. Analysis and evaluation are done by the HPLC analysis device and the associated analysis software (different providers: Agilent, Shimadzu, Waters etc.).
A simple way
to HPLC analysis
After dissolution testing* 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, the medium is first filled in a transfer block (PEEK block), and afterwards distributed into appropriate vials. If required, the samples can be diluted for immediate analysis or cooled and stored temporarily against UV radiation for later analysis.
The HPLC analysis starts as soon as a sample is filled into the HPLC valve of the sampler and a trigger signal is sent by the Disso.NET to the HPLC device. The analysis as well as the evaluation are done by the analysis software of the corresponding HPLC manufacturer on a separate PC. As the analysis times of the samples are defined beforehand via the Disso.NET software, the sampler steadily passes the samples to the HPLC device (even after the termination of the release). Consequently, the dissolution test with HPLC analysis can be performed automatically without an operator (e. g. also at night). After the HPLC analysis, the results are displayed on a separate PC.
Disso.NET
Full dissolution software solution
The ERWEKA Disso.NET software is the perfect companion for our semi-automated dissolution HPLC On-/Offline systems. The software takes over full control and offers support for all test methods, that can be applied with the dissolution system with HPLC analysis.
Disso.NET helps you with standard dissolution jobs, handles qualification tasks and provides control over each single function of the connected devices (e.g. DT, PVP and auto sampler). In addition, the software includes an easy to handle method editor for comfortable programming of dissolution methods (for highest safety in GMP environment). Our audit trail also generates detailed protocols of all events and times and thus enables tracing changes at any time. After finishing 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 file).
HPLC Sampler
Reliable and flexible collection of samples
With the HPLC sampler samples can be collected and stored reliably and flexibly for subsequent HPLC analysis. It excels through its mechanical precision and its compact design. In addition, the open and modular unit design enables the exchange of single components within a short period of 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, thus ensuring a quick, reproducible injection of the samples into the vials. In this way, potential mixing of the individual samples can be avoided.
The sampler is easily controlled by our ERWEKA Disso.NET software.
Automatic Filter Changer AFC 825
Media replacement with membrane filters
We 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. 0.22 μm, 0.45 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. 8x25 filter) and comes in two configurations:
- AFC 825 with 12 valves for 6 stations
- AFC 825 with 16 valves for 8 stations
Comprehensively configurable
Our systems with HPLC analysis
- 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 a HPLC Sampler with 2 transfer blocks (PEEK blocks)
- Optional spectrophotometers:
- Shimadzu
- Agilent
- Waters
- IQ/OQ/PV documents and services available
Gallery
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On-/Offline System with HPLC brochure
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