Dissolution UV-Vis Systems Semi-Automated Dissolution System USP Apparatus 1, 2, 5 and 6 The ERWEKA dissolution systems are intended for dissolution tes-The ERWEKA dissolution system is a flexible system that comprises ting of tablets, coated tablets, oblongs and other dosage forms for different measuring and analytical equipment. Depending on the de-quality control and development. These systems have been desig-mands, various types of dissolution systems can be applied. online, ned according to the USP and EP requirements and fully conform to offline and off-/online. the safety requirements for electronic laboratory equipment. The RoboDis II offers state-of-the-art technology in a modern de-sign. See a video at www.erweka.com ution solisD is V-V Component Highlights U System Highlights ■ Different racks available for glass tubes or HPLC vials ■ Handling of septa-sealed HPLC vials ■ Full support of USP Methods 1, 2, 5, 6 ■ Easy access to sample tubes ■ 100% USP/EP compliant system ■ Easy to clean ■ Automated sampling with automatic USP height adjustment and optional measuring of temperature in each vessel Software Highlights ■ Automated tablet drop (option) ■ Complete integration of different types of spectrophotometer ■ Controls different types of spectrophotometer without the ■ High analytical flexibility due to additional integration of sam-need of additional vendor software required ple collector (e.g. for later HPLC measurement) ■ Easy recalculation of results ■ Measuring of complete spectra ■ 21 CFR Part 11 compliant ■ Media replacement ■ Calculation of dissolution profiles via UV-measurement ■ MS SQL database with local or network installation Pump Highlights ■ Support for computer based ERWEKA dissolution systems, capable of testing USP methods 1, 2, 5 and 6 ■ IPC pump – reasonable price and easy to handle, inert mate- ■ Multiple System Suitability Tests for highest reliability rial, 8 channel and 16 channels possible ■ Easy approach from top to bottom ■ PVP piston pump – for double filtration down to 0.22 μm for ■ Semiannual check of the photometer according EP flat membrane filters, high precision, inert ceramic material pump heads, almost maintenace free Sample Collector FRL Highlights ■ 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 racks Dissolution UV-Vis Online System Standard Online System with UV-Vis Spectrophotometer The online dissolution system consists of a DT 820, an IPC 8 and is fitted with a UV-VIS spectrophotometer for measuring absorption after testing. Dissolution Tester Automatic Sampling Station Peristaltic Pump UV-Vis Spectrophotometer Disso.NET Software DT 726 / 727 / 728 ASS-8 IPC 8 Shimadzu 1800 ü or Agilent 8454 DT 1412 Online System with UV/VIS Spectrophotometer The UV-Vis Online system can also be configured with a DT 1412. It offers the possibility for one test with 12/13/14 tablets or two tests with 6/7 tablets. The System consists of a DT 1412 with an ASS-14 autosampling station, an IPC-16 pump and the Analytik Jena Specord 210 Plus UV-Vis Spectrophotometer. All system components are controlled by a computer via the industry-proven Windows-based Disso.NET software. Dissolution Tester Automatic Sampling Station Peristaltic Pump UV-Vis Spectrophotometer Disso.NET Software DT 1412 ASS-14 IPC 16 Analytik Jena Specord ü 210 plus Dissolution UV-Vis On-/Offline System On-/Offline System with DT 72x-Series A high degree of automation and flexibility is offered by the half-automated on-/offline dissolution system. It 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. Dissolution Tester Automatic Sampling Station Peristaltic Pump UV-Vis Spectrophotometer Sample Disso.NET Collector Software DT 726 (DT 727 / ASS-8 IPC 8 Shimadzu 1800 FRL 624 ü 728 possible) or Agilent 8454 On-/Offline System with DT 1412 The DT 1412 with 12 test stations can also be configured as an UV-Vis On-/Offline system. This configuration has an ASS-14 autosampling station on top of the tester and an IPC-16 pump which connects to an Analytik Jena Specord 210 Plus UV-Vis Spectrophotometer and FRL 624-2 sample collector, all managed via PC and ERWEKA Disso.NET software. Dissolution Tester Automatic Sampling Station Peristaltic Pump UV-Vis Spectrophotometer Sample PC + Disso.NET Collector Software DT 1412 ASS-14 IPC 16 Analytik Jena Specord FRL 624-2 ü 210 plus Technical Specifications Sample Col ector FRL 624 / 724 / 824 System Control with Disso.NET Auto sample collector with 6 to 8 channels for sampling up The Disso.NET Software offers support of all methods to 26 intervals; 1 driven dosing arm with 8 stainless steel manageable with the ERWEKA DT dissolution testers. The (optional Titanium) dosing needles, RS 232 interface for Software helps you with standard dissolution jobs, hand-external control by Disso.NET software. les qualifying tasks and provides control over each single function and connected device. Sampling tubes and HPLC vials 26x 8 glass tubes of 12 ml capacity ■ MS SQL database with local or network installion 18x 8 glass tubes of 25 ml capacity ■ Multiple System Suitability Tests for highest reliability. 26x 8 HPLC vials of 1.5 ml capacity ■ Full audit trail according to 21 CFR Part 11 including 26x 8 HPLC vials of 4.0 ml capacity date, time stamp, user ID Handling of septa-sealed HPLC vials ■ Integrated workflow for approval and review of The RoboDis II offers state-of-the-art technology in a modern de-reports before publishing sign. See a video at www.erweka.com ■ pH-change support according USP-Method A and B ■ Easy XML, PDF, Excel ex-/import for LIMS commu-nication ■ Seminal check of the photometer accoding EP Spectrophotometer Options for ERWEKA UV-Vis Systems Shimadzu UV-1800 Agilent 8454 Analytik Jena Specord 210 plus Range 190-1100 nm 190-1100 nm 190-1100 nm Bandwidth 1 nm 1 nm 1.4 nm Type Dual beam scanning DAD Dual beam scanning Connection USB LAN RS232 Special Stand-alone operation possible Typical scantime for full spectra: Up to 16 channels 1.5 s Height x Width x Depth 270 x 450 x 490 mm 185 x 344 x 560 mm 590 x 260 x 690 mm Weight 15 kg 16,5 kg - Technical specifications for the products described are stated ERWEKA GmbH Ottostr. 20 - 22 without warranty and subject to change at any time. sales@erweka.com 63150 Heusenstamm v.1.1.11.17 +49 (6104) 6903-0 Germany