Dissolution On-/Offline System with HPLC Semi-automated dissolution testing with HPLC analysis Semi-automated dissolution 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 720 series dissolution testers with devices for CTC sampling and online HPLC chromatography. The entire system is controlled by our Disso.NET Set-up Tablet drop, stirring Automated Sample storage in glass Analysis of samples Cleaning process software. of baskets or paddles Sampling & Filtration tubes or HPLC vials (UV-Vis or HPLC) Dissolution Steps 1. 2. 3. 4. 5. 6. 7. 8. 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 Available from Available from optional ERWEKA ERWEKA 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 analysis device not included 100% USP/EP/ 21 CFR Part 11 conform in system configuration! (Support JP compliant in conjunction with of various manufacturers) Disso.NET software NOTE CTC sample collector 5 of 8 dissolution steps and sample storage are automated for HPLC Dissolution Tester DT 720 The dissolution tester of the DT 720 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. HPLC sample collection & analysis PVP 820 Pump With the HPLC sampler the samples can be collected (and cooled) and The test medium is transported with high precision and pressure via injected automatically in the HPLC system. Analysis and evaluation are eight channels to the automated filter changer AFC 825 by the practically done by the HPLC analysis device and the associated analysis software maintenance-free piston pump. In conjunction with the AFC 825, it en- (different providers: Agilent, Shimadzu, Waters etc.). ables a filtration with up to 0.22 μm flat membrane filters. Double filtration with AFC 825 Disso.NET Software In case of a HPLC analysis it is recommended to perform a double filtra-Our advanced dissolution software solution Disso.NET takes over full tion, to avoid contamination or damage of the HPLC column due to par-control of the dissolution system and offers extensive functions, en-ticles, thus improving the accuracy of the HPLC analysis. The high-pre-hanced user management and diverse data export options (e.g. LIMS cision, practically maintenance-free PVP pump in combination with the connection). automated filter changer are particularly suitable for this purpose. 2 3 Semi-automated dissolution system Semi-automated dissolution system with HPLC analysis with HPLC analysis Disso.NET Ful dissolution software solution trigger signal Disso.NET The ERWEKA Disso.NET software is the perfect companion for the Highlights 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. Audit trail Disso.NET helps you with standard dissolution jobs, handles quali-fication tasks and provides control over each single function of the Easy control of the connected devices (e.g. DT, PVP and auto sampler). In addition, the On-/Offline systems software includes an easy to handle method editor for comfortable programming of dissolution methods (for highest safety in GMP envi-Sample is filled into Sample is filled into Sample is filled into HPLC analysis is triggered ronment). The audit trail also generates detailed protocols of all events transfer block vials for storage HPLC transfer valve by a signal from Disso.NET and times and thus enables tracing changes at any time. After fin-MS SQL Database ishing the dissolution test, Disso.NET creates comprehensive reports HPLC communication 1. 2. 3. 4. (as PDF-files or printouts) and can export all results in various for-mats (e. g. as XML file). Advanced report generation A simple way to HPLC analysis Upon request data export to LIMS After dissolution testing* with the DT 720 and double filtration with Full control with Disso.NET software systems! NOTE the PVP 820 pump and the AFC 825, the medium is transferred to Not included in system config-the HPLC sampler. There, the medium is first filled in a transfer block uration: (PEEK block), and afterwards distributed into appropriate vials. If required, the samples can be diluted for immediate analysis or cooled** ■ HPLC analysis device and stored temporarily against UV radiation for later analysis. ■ HPLC analysis software (on a separate PC) 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 Our Dissolution On-/Offline by the analysis software of the corresponding HPLC manufacturer System with HPLC supports on a separate PC. As the analysis times of the samples are defined different manufacturer (e.g. beforehand via the Disso.NET software, the sampler steadily passes Agilent, Shimadzu, Waters). 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). NOTE After the HPLC analysis, the results are displayed on a separate PC. *Also during the test, at certain sampling times. ** Option 4 5 Simple & automatic Full dissolution software solution The way to HPLC analysis Disso.NET Comprehensively configurable Media replacement with membrane filters Our systems with HPLC analysis Automatic Filter Changer AFC 825 Our semi-automatic Dissolution On-/Offline Systems with HPLC distinguish themselves in particular We recommend the implementation of a second filtration to avoid Highlights through a high degree of automation and flexibility. This enables you to specify your HPLC system tai-contamination or damage of the HPLC column due to particles, thus lored to your individual needs. improving the accuracy of the HPLC analysis. In combination with No plugging of the the high-precision, practically maintenance-free PVP pump, we of-HPLC column! fer 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 Automated filter change 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 Integrated in Disso.NET 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 posi-We offer the fol owing configurations (Note - HPLC analysis device is not included): tions for membrane filters (max. 8x25 filter) and comes in two configurations: ■ HPLC On-/Offline Dissolution System with DT 720, PVP 820 Pump and AFC 825 (recommended) ■ HPLC On-/Offline Dissolution System with DT 720, IPC 8 Pump and AFC 825 ■ AFC 825 with 12 valves for 6 stations ■ Optional: Connection of 2 DTs (including 2 x PVPs or IPCs) to a HPLC Sampler with ■ AFC 825 with 16 valves for 8 stations 2 transfer blocks (PEEK blocks) Reliable and flexible collection of samples HPLC Sampler With the HPLC sampler samples can be col ected and stored reli-ably 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 compo-nents within a short period of time. If required, the col ected samples can be diluted or stored temporarily cooled and UV-protected for later analysis. The HPLC sampler automatical y 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 control ed by the Disso.NET software. 6 7 Comprehensively configurable Media replacement with membrane filters Our systems with HPLC analysis Automatic Filter Changer AFC 825 Technical data DT 720 Series PVP 820 Appliance details Dissolution tester for USP methods 1 Appliance details Valve-free sample dilution (Basket), 2 (Paddle), 5 (Paddle-over-disk) pump for highly precise media and 6 (Rotating Cylinder) with 6, 7 or 8 transfer with 6 or 8 channels Test stations (726, 727, 728) in 2 lines Width/Depth/Height 280 mm / 450 mm / 410 mm Vessel 1000 ml, optional: 2000 ml, temperatur sensor in each vessel; Weight 22 kg manual tablet drop magazine Device control Alphanumeric keypad Device control LED display, for each test with LC display parameter with function keys Material Ceramic pistons, cylinders Compliance 100% USP/EP/JP compliant and PTFE tubes (Avoidance of Width/Depth/Height 830 mm (including heating) absorption of medication) / 640 mm / 940 mm Accuracy High accuracy (+/- 1%) Weight 47 kg Pump heads Fine adjustment mechanism for Rotation Speed 20 - 220 U / min. recalibration by the operator, automatic ventilation Water bath 20 liter Output 25 ml/min. (Standard) Evaporation Less than 1% (50 UpM / 1000 ml / Power 100-240 VAC / 50/60 Hz, 100 W 37° C / 24 h) Heating ■ Heating rate: 1500 W Interfaces RS 232 for external control, ■ Heating range: 30-50° C RS 485 interfaces, USB-A Power 115 or 230 VAC, 50/60 Hz and USB-B interface, SD card, Ethernet connection Fuses 115/250V, 16A, 250V, 1A/115V, 2A Interfaces ■ RS 232 for PC connection ■ USB-B for firmware updates ■ USB-A printer interface for docu-HPLC Sampler (PAL RSI) mentation of test parameter time, Appliance details Sampler date, temperature etc. (optional) Dimensions with 600 mm / 795 mm / 770 mm Standard legs (Width/ Depth/Height) AFC 825 Work surface (Width/ 420 mm / 255 mm / 420 mm Depth/Height) Appliance details Automated filter changer Weight 17.8 kg Width/Depth/Height 215 mm (without filter refill) or Sample capacity 2 tablet holders, up to: 580 mm (with filter refill) / ■ 420 x 1 ml vials 200 mm (without valves) or 215 ■ 324 x 2 ml vials mm (with valves) / 610 mm ■ 90 x 10/20 ml vials Filter requirements ■ Pore size: 0.22 μm, 0.45 ■ 6 MT / DW discs μm, 0.70 μm, 1.0 μm, 10 μm Sample capacity, 1 peltier modul, up to (with 6 DW): ■ Diameter: ≤ 30 mm for automation temperature- ■ 420 x 1 ml vials Power 100-240 VAC +/- 10% / 50 and 60 Hz controlled (4-40° C) ■ 324 x 2 ml vials Fuses 115 V / 250 V, 2 x 3.15 A ■ 90 x 10 ml vials ■ 6 MT / DW discs Interfaces RS 232 (one), RS 485 (two) ERWEKA GmbH E-Mail: sales@erweka.com Technical specifications of products described are stated without Pittlerstr. 45 warranty and subject to change at any time without further notice. 63225 Langen Phone: +49 6103 92426-200 v.1.3.4.19 Germany Fax: +49 6103 92426-999