Aurius UV Vis Spectrophotometers Offer Optional GLP/GMP Validation Module

Performance Validation

Instrument performance may be validated using a comprehensive software module available on all instruments and which may be released by E-SEF.

Tests are provided for laboratories subject to regulatory control or following good G.L.P. These include a range of Pharmacopoeia tests (EP/BP/USP), a selection of which is shown here.

Optical Bandwidth

The very accurate method for validating optical bandwidth uses the narrow deuterium emission line at 656.1nm. The width, at half height, of the measured band due to the emission line measures the actual bandwidth. The band is drawn and the half width automatically documented.

Absorbance Validation

The Pharmacopoeia (EP/BP) test for absorbance accuracy is one of the tests provided. The test measures the values of peaks and valleys in the absorbance spectrum of a 60mg/L solution of Potassium Dichromate in a 10mm pathlength cuvette. The results of such a test run are shown here.

Straylight

Straylight may be measured using the Pharmacopoeia (EP/BP) test shown here. This test uses a 1.2% W/V solution of Potassium Chloride in water, measured against water in the reference beam. An absorbance in excess of 2A must be measured at a wavelength of 200nm.

The ASTMS tests at 220nm and 340nm are more widely used and are provided for.

Validation Using Filters

Absorbance and Wavelength validation are most conveniently carried out using filter sets calibrated by Cecil Instruments on its reference spectrophotometer against standards certified by the NPL. Full validation programmes for these tests are provided.