Regular UV/Vis performance verification ensures that the instrument functions properly, guaranteeing accurate and reliable results. The performance verification tests, which include photometric accuracy, photometric linearity, wavelength accuracy, resolution, and stray light, are compliant with both the US and European Pharmacopeias.
There is no need for manual data transfer because the entire workflow is automated. The FDA’s guidelines regarding electronic records are met when used in conjunction with LabX™ laboratory software, thereby facilitating compliance with 21 CFR Part 11 regulations. To ensure data integrity, all data are stored by the ALCOA+ guidelines.
The Secret to Accurate Results: Automated Performance Verification for UV Vis Spectrophotometers
Video Credit: Mettler-Toledo International Inc.
Complete traceability
Image Credit: Mettler-Toledo International Inc.
Complete traceability of test results is provided by the automated CertiRef™ and LinSet™ modules. The Hellma Analytics LinSet module includes NIST-traceable certified reference materials with calibration certificates in both modules. The CRMs adhere to the most recent Ph. Eur. and USP regulations. Both modules securely store all certification data. The outcomes of the tests are automatically assessed and recorded in an extensive report.
Keep up with the latest regulations
Image Credit: Mettler-Toledo International Inc.
New reference materials and mandatory photometric linearity have been added to Ph. Eur. Ed. 13 and USP 43’s respective chapters on UV/Vis spectroscopy. The updated testing routine is guaranteed by the LinSet automated performance module, which covers the recently introduced changes.
There are two configurations of the LinSet module: LinSet PDC and LinSet Niacin. The CRMs that are used to test the photometric linearity in the UV range (potassium dichromate and nicotinic acid, respectively) are different.
The UV7 Excellence Spectrophotometers can be used with the LinSet modules.
Error-free evaluation and documentation
Image Credit: Mettler-Toledo International Inc.
The CertiRef™ and LinSet™ modules electronically store all nominal data needed for evaluation, which is then automatically compared to the test results. Errors resulting from user computations and manual certificate data entry are removed.
Comprehensive, editable reports that can be printed, exported, or stored electronically can be used to record test results. The test history allows for trend analysis and contains all pertinent data for comparison with past test results.
Easy installation and use
Image Credit: Mettler-Toledo International Inc.
The automated performance modules are simple to install in a matter of seconds—just plug and play. The device is ready to begin the performance verification procedure right away after it automatically identifies the module and retrieves all certification data. The modules are easily removable for use on other instruments or can be left mounted on the instrument for regular measurements.
Products and specs
Source: Mettler-Toledo International Inc.
| |
Performance tests |
Number of CRMs |
Performance verification CertiRef EUP
Automated performance verification tests compliant with EU Pharmacopeia for resolution, photometric and wavelength accuracy as well as stray light. Comprehensive report documents are automatically generated. |
Photometric Accuracy; Stray Light Ph. Eur.; Wavelength Accuracy; Photometric drift; Photometric noise; Wavelength Repeatability; Photometric repeatability; Resolution |
7 |
Performance verification CertiRef USP
Automated performance verification tests compliant with US Pharmacopeia for resolution, photometric and wavelength accuracy as well as stray light. Comprehensive report documents are automatically generated. |
Photometric Accuracy; Wavelength Accuracy; Photometric drift; Photometric noise; Wavelength Repeatability; Stray Light USP; Photometric repeatability; Resolution |
7 |
Performance Verification LinSet PDC
Automated performance verification module compliant with Ph. Eur. and USP. Covers photometric linearity (UV and Vis) and photometric accuracy and repeatability (Vis) tests. Comprehensive report documents are automatically generated. |
Photometric linearity UV; Photometric linearity Vis; Photometric accuracy Vis; Photometric repeatability Vis |
7 |
Performance Verification LinSet Niacin
Automated performance verification module compliant with Ph. Eur. and USP. Covers photometric linearity (UV and Vis) and photometric accuracy and repeatability (Vis) tests. Comprehensive report documents are automatically generated. |
Photometric linearity UV; Photometric linearity Vis; Photometric accuracy Vis; Photometric repeatability Vis |
7 |