ANTEC - Model Fusion - TOC Analyzer for Pharmaceutical Applications

The TOC Fusion was developed according to the specifications of the pharmaceutical industry. Comprehensive documents are available for the TOC analyzer to carry out the IQ, OQ and PQ.

• 21 CFR Part 11 compliant (21 CFR Part 11 statement available)
• Data Integrity and Compliance with TekLink
• Electronic Records and Electronic Signatures (ERES)
• system-integrated audit trails
• Audit Trail records all user input and changes
• Audit trail and all user entries cannot be changed / deleted
• Reading the audit trail via filters available to filter by individual attributes (info, warning, error, text filter)
• Audit trails cannot be deactivated
• all data from previous versions can be read
• exported data is protected against manipulation during re-import
• User account management
• multi-level role concept
• User is automatically logged out of the application if inactive
• To use the application, authentication using user name and password is required
• Electronic signature present and firmly linked to the data
• Data (methods, sequences, calibrations and others) cannot be deleted
• No change of measurement data (e.g. at operating system level, Explorer, etc.) possible
• Measurement data is saved automatically
• Data cannot be printed before saving
• Application offers the possibility of a consistent and complete back-up
• extensive IQ, OQ, PQ validation documents
• Change Management

Data Integrity and Compliance
Backup data is exact and complete. Intentional or unintentional deletion of data is impossible.
The sample reports are created from the protected raw data (original data set). All changeable data such as methods, sequences, calibrations, etc. are not overwritten, but saved in versioned form. Changes can be traced at any time.
Electronic signatures (ERES), audit trails and user account function.
Automated system suitability test SST (system suitability test) with automatic evaluation.
Automated check standard with automatic evaluation.

The TOC Fusion offers maximum flexibility and, thanks to its high degree of automation, such as the automatic calibration function, is an ideal TOC analyzer for demanding laboratories.

The Total Organic Carbon (TOC) device is a computer-based system and is used to determine the total carbon in water, for example. The Fusion uses powerful UV persulfate oxidation, which breaks down even difficult matrices.

The associated TekLink software is used to measure and evaluate the data generated, as well as to control the TOC device. The Fusion is based on the latest technology and processes a variety of different applications. The operating program contains predefined methods for all TOC applications, measuring ranges, automated calibration and the automated system suitability test.

• Unattended, automated calibration via set standards (user)
• Unattended calibration via automatic dilution of a stock solution by the device (stock)
  • Automatic determination of the calibration and automatic evaluation by the program (evaluation of the correlation R² > as x, slope min./max. and the calibration factor min./max., each linear or quadratic). In the event of a deviation, an action (continue working, pause, recalibration or manual calibration) can be selected, which the device then carries out automatically.

• Automatic measurement of check standards with evaluation by the program (% deviation min./max.). In the event of a deviation, an action (continue working, pause or recalibration) can be selected, which the device then carries out automatically.
• Automatic measurement of system suitability tests with automatic evaluation (reagent water </= 0.1 ppmC or self-defined, response efficiency (%) must be between 85% and 115% or self-defined.)

• Easy creation of methods and sample sequences
• Automated self-diagnosis
• Exportable reports in freely definable formats including metadata and versioning