ARGUS/Dissolution
Dissolution Automation & Data Management
ARGUS/Dissolution is scientific dissolution data management software designed by users for users. It is used for instrument control, data acquisition, management, processing and reporting. Whether you perform dissolution tests occasionally or several times a day, ARGUS/Dissolution will increase your productivity when running tests and analysing results. ARGUS/Dissolution simplifies the collection and reporting of dissolution test results, letting you choose an analysis template that matches your workflow. Whether you work in QC and are concerned about data integrity, compliance and validation, or you need maximum flexibility in R&D, ARGUS/Dissolution can help your lab to perform more efficiently. Intuitive wizards help everyone in your lab work more effectively — you can start your next dissolution test in just a few clicks.
Providing reliable results more quickly
- Access dissolution data quickly from a database
- Analyze multi component drugs
- Drives spectrophotometersand baths of market leaders
- Grow from single workstations to a laboratory network
- Have data integrity and 21 CFR Part 11 compliance
Maximize productivity
ARGUS/Dissolution represents a fundamental shift in the usability of dissolution software. Designed for every user in your lab, regardless of their task or skill level, the software features unique Analysis Template Technology. Use the Analysis Wizard to set up parameters and run tests with either minimal input or maximum flexibility. You can navigate the entire environment from the ARGUS/Dissolution desktop, including instrument control, real-time dissolution profiles and an area in which to recalculate raw data or create reports. Review your data without creating reports. Data is displayed in a ‘what you see is what you get’ format and can be signed off electronically. With raw data, methods and report templates stored centrally within the same database, you can easily share information with colleagues or print reports that include only the details you want. You can export data into CSV and JCAMP-DX formats to import your dissolution profiles and spectra into third-party software such as LIMS or office applications.
Exchange data and reports
With raw data, methods and report templates all stored centrally within the same database, it is easy to share information with colleagues and to print reports that include only the details you want.
You can export data in CSV and JCAMP-DX formats to import your dissolution profiles and spectra into third-party software such as LIMS or office applications.
Compliance
Maintaining regulatory compliance is easy with ARGUS/Dissolution. Use the System Qualification Wizard to schedule your next qualification tasks.
Validation protocols covering the software, spectrophotometer, baths and accessories are available for systems driven by ARGUS/Dissolution. ARGUS/Dissolution automatically creates detailed audit trails to record changes to methods, analyses, system configurations, and other relevant data.
Each entry is identified by the date and time of the modification, along with the operator’s name. Secure system authentication ensures that only authorised users can access the system.
Permissions for each action can be combined into roles representing method developers, system administrators, operators, or any other role required in your working environment. As a system administrator, you can assign one or more roles to each user.
Get more information from your test results
ARGUS/Dissolution works across the full spectrum, providing more reliable scattering detection and enabling multi-linear regression models, which result in more accurate multi-component analysis.
Dissolution calculations
ARGUS/Dissolution already has built-in calculations that correct for volume changes and mass loss. This all-in-one approach means that the time-consuming and error-prone process of transcribing data collected from various sources into spreadsheets will be a thing of the past.
Create your automatic cleaning program
ARGUS/Dissolution let you translate your experience with best cleaning procedures into a permanent program.
Cleaning tubing and flowthrough cells of an online dissolution system with multiple baths is reliably accomplished with a simple click.
Video & pictures
A picture tells a thousand words. Consequently, ARGUS/Dissolution allows standard USB webcams to be used to take photos or record videos during a dissolution test.
These images can be included in the report, providing tremendous assistance during analytical development. Video monitoring, on the other hand, can improve understanding of dissolution processes, particularly those involving new formulations.
Enhanced data management
ARGUS/Dissolution meets all your data management needs, from instrument control to final reports, making your lab more productive. No matter what type of laboratory you work in, you can focus on science rather than data transcription or file management. The strength of ARGUS/Dissolution lies in its reliability:
- It collects and stores test results, automatically linking the system configuration and method parameters to each dissolution test.
- It also connects data and any subsequent modifications with the identity of the operator using the computer system.
- It logs relevant events, errors, and login failures.
Future-proof technology
Designed to be your versatile tool for managing your lab’s dissolution test workload while reducing your validation effort to a minimum, ARGUS/Dissolution is built on industry standards and developed according to the regulations and guidance set forth in 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP). Whether you need to control a single bath or support dissolution workflows spanning the entire laboratory and beyond, ARGUS/Dissolution offers the right configuration for you. The database can run on a single workstation or on a server. New clients can be easily added to both, and you can migrate from a standalone system to a dissolution laboratory network.
Drive the equipment you need
The ARGUS/Dissolution software is compatible with almost all dissolution equipment from any vendor on the market. Choose your preferred baths, pumps, spectrometers and accessories to build the dissolution system you need, or upgrade existing devices to automated systems at minimal cost.
Spectroscopy system
Designed for UV/Vis sample analysis. Whether you withdraw your aliquots manually or automatically using an offline system, ARGUS/Dissolution is the perfect solution for continuing your dissolution test workflow with just a few clicks. Arrange sample sequences from various baths on your XYZ auto sampler for unattended analysis. Spectra are automatically linked to your analysis dataset, with dissolution values calculated instantly.
Offline system
Designed for systems with one or more baths for automated or manual sampling into vials for offline HPLC or UV/Vis analysis. With the ARGUS/Dissolution software, you can record stirrer speed, temperature, sampling and other events required for the accurate calculation of dissolution results. You can easily convert raw data into a report and add analytical data as required.
Online UV/Vis system
For unattended withdrawal and analysis of samples which recently became indispensable whenever dissolution profiles are required or when the throughput of your bath should be high even during the night or on weekends.
Online HPLC system
This is for the parallel sampling of one or more dissolution baths, followed by the sequential analysis of the samples by HPLC. The ARGUS/Dissolution software transfers work lists or sample sets to the CDS, triggers the start of the chromatogram, and imports peak lists or result sets in order to calculate dissolution profiles.
Fiber-optic system
It is designed for in situ analysis within the vessel. ARGUS/Dissolution copes with the challenges of multi-channel fibre optic measurement and enables data collection rates that are only limited by the spectrometer.
Data client
Review or recalculate dissolution tests from the office. This includes a powerful set of tools that can be found in other configurations, such as profile comparison (F1, F2 calculation), intrinsic dissolution calculation, electronic signing and exporting to LIMS, text files or PDFs.
Multiple baths
Adding a second or a third bath to your dissolution system can be done with a minimum of fuss. Even if it is another make and model ARGUS/Dissolution will simply incorporate it into the new configuration and reliably detect sampling time collisions – before the pill drops.
Analyze combination drugs in one effort
Do you want to analyse two or more active ingredients in one drug without incurring the costs and time overheads of HPLC analysis, while enjoying maximum convenience and automation? ARGUS/Dissolution has the necessary chemometric power. You can choose between multilinear regression and even more sophisticated models, such as PLS, which are created using the well-known software, The Unscrambler® from CAMO. Thanks to ARGUS/Dissolution’s intuitive, one-stop design, handling these calibration models is as easy as applying common calibration types.
Usability
- Wizards for major functions
- Tooltips and context sensitive online help « Document search capabilities
- Analysis template technology
- Emergency stop capability
- English and German user interface
- Detection of possible timing problems
- Real time dissolution profiles
- Customizable report templates
- “WYSIWYG” method- and analysis display
- Raw data export (Excel or JCAMP-DX)
- Power and lamp saving functions
- Programmable cleaning procedures
Analytical capabilities
- Full spectrum support
- Peak picking on all spectra charts
- Savitzky-Golay second derivative
- Turbidity baseline
- Placebo effect elimination
- Single and Multi Component Analysis
- CAMO The Unscrambler model support
- Recalculation of analyses
- Statistics (pH, temperature, dissolution)
- Infinity test, temperature profile
- Automated media change Profile comparison (f1/f2)
- Intrinsic dissolution
USP and Pharm. Eur. Acceptance
- One or more Q-values for each API High/low dissolution boundaries
- USP S1, S2 and S3 testing in one record
Data Integrity and 21 CFR Part 11
- Instant recording of raw data
- Standard database backup and recovery procedures
- Long term persistence in XML
- Detailed audit trail for electronic records
- System log for tracking application events Electronic signature support
- Cryptographical record protection
- Role specific access to program functions
- IQ/0Q/PQ support with reminder function
- Built in system suitability check
- Failsafe technology for data recovery
- Full Spectrometer OQ (as outlined in USP38)
Features
- ARGUS/Dissolution controls your dissolution testing hardware. It acquires data from all the devices used in your dissolution test setup, including the bath, spectrometer and pump. Methods and analyses are retrieved from and stored in the documents database.
- Connect multiple dissolution test laboratories to one central database.
ARGUS/Dissolution can be used offline to query, review, approve, release and electronically sign methods and analyses. - Use ARGUS/Dissolution to exchange data with your LIMS or enterprise document management system (EDMS).
- Query or browse methods, analyses and other data using any standard web browser.
- ARGUS/Dissolution runs on a Java Virtual Machine, making the application secure and extremely stable, as required in highly regulated GxP environments. Centralised deployment and version control is easily accomplished with the ARGUS Software Deployment Server.
- If you are already running the standalone version of ARGUS/Dissolution, migration to an enterprise version is always possible. All data (methods, analyses, etc.) can easily be transferred.
Enterprise integration
ARGUS/Dissolution is based on the reliable ARGUS platform, which seamlessly integrates dissolution testing into your corporate environment (e.g. LIMS). It enables the exchange of methods and analyses between development and QC laboratories. ARGUS/Dissolution is compatible with your existing dissolution testers and can also integrate additional hardware, such as spectrophotometers. The ARGUS platform’s client-server architecture fits perfectly into your corporate network.
Groupware functionality (enterprise edition)
- Method deployment via shared database
- Centralized user account management
- LDAP authentication (ActiveDirectory)
- Prepared for LIMS connectivity
- Review Data through your web browser
Database compatibility
- MariaDB
- MySQL
- Microsoft SQL Server
- Oracle
Spectrophotometer Driver
- Agilent 8453,8454, Cary 60
- AnalytikJena 200/205/210/250
- Beckman DU800
- Cecil 1000/2000/3000/4000/7000/9000 series
- EMCLAB-18S/11S
- Kontron Uvikon XL; Cecil 2000/3000/4000/ 7000/9000 series
- Mettler-Toledo UV7/UV5
- PerkinElmer LAMBDA 2/20/25/35/45, LAMBDA 465
- PG Instruments T70/T70+
- PharmaTest SA500
- Shimadzu UV1700 PharmaSpec, UV1800, UV1900
- Spectrum Instruments SP-UV300SRB, SP-UV500DB/VDB
- Tec5 Multi-Spec
- Thermo Evolution 300
- Tidas II (9-channel fiber optic)
- Varian Cary50
- Zeiss MCS5XX, MCS6XX(2-channel fiber optic)
Pump driver
- Agilent 850–DS/VK806 Syringe Pump
- Teledyne Hanson AutoPlus MAXIMIZER, Vision G2 AutoPlus
- Hamilton Dynamix III
- Masterflex ISMATEC IPC/IPC-N, Reglo ICC
- Sotax CY- 750, CP7
- Varian Vk806
- Watson Marlow 323Du
- Distek Evolution 4300
- Micamix Dual Syringe Dilutor
Dissolution tester driver
- Agilent 708-DS
- Copley DT600, DT800
- Distek 2100, 5100, Evolution series
- Electrolab EDT08-Lx
- ERWEKA DT80/700/800, DT720
- Teledyne Hanson SR8+, Vision/Vision G2 Elite & Classic 6, CD14
- Pharma Test PTWS300/IDS1000, PTDT8, PTWS1210, PT WS120/620/820/1220/1420/D620, PTWS830/1230/D630
- Sotax AT7/AT7smart, AT Xtend
- Varian Vk7000,7010,7025,7030
System requirements
- 1 GB RAM recommended minimum
- 200 MB hard disk space recommended minimum
- Intel® Pentium® III or compatible at 800 MHz or better + CD-ROM drive (only for installation)
- Monitor (1280×1024 or higher, 256 colors or better)
- Mouse or other pointing device
- RS232/Ethernet/USB (USB adapters can be used)
- Microsoft® Windows® XP, Vista, 7, 8, 8.1 or 10
- Adobe® Acrobat® Reader (to view manual)
- Microsoft® WinHelp (to view online help)