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The author of this page is independent and has no commercial intention in mind ! | Diese Seite in Deutsch. | |||||
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| System Suitability Test (SST) —
IQ, OQ, PQ, and PV: |
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| Are you spending a lot of time, solvent, glassware, washing powder, and manpower for the following tasks?: | ||||||||
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Here is a solution for you: |
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Do not "drop the hammer", when you are not absolutely familiar with 'Diode Array Spectrophotometers' ! I'm sure in time, not so far, you will have difficulties to find a new spectrophotometer with scanning technology, at all ! |
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| Please let me give you for the first moment the cover-page' of our publication. When it will be published in the different spectroscopy journals, I will present you the whole contents and even a little more: | ||||||||
New System Suitability Test for Diode Array Spectrophotometers Authors: Nicola J. Parvin, 135 Nanpantan Road, Loughborough, Leicestershire LE 11 3YB, UK. Yvette Cornélis and Peter Forster,* Software Development & Consulting, CH-4002 Basle, Switzerland |
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| Summary Traditional System Suitability Tests (SST), as recommended by Pharmacopoeia, GLP, ISO, IUPAC and NIST, -- often related to the terms IQ, OQ, PQ, and PV --, are not satisfactory for diode array spectrophotometers, especially when being used in conjunction with chemometric algorithms. They do not guarantee enough security and trustworthiness for daily and routine work. This report describes a new, more adequate and reliable system suitability test for an ultraviolet-visible diode array spectrophotometer, and compares it with the traditional tests. It is shown how easily the implementation for the routine and production control processes can be realised. Excellent experience of more than 500 spectrophotometer life years (over 35 instruments) with high reliability and reproducibility guarantees the success of the new SST. It's obvious, that this test with similar improvement can easily be applied to almost every other 'wavelengths range'. Content:
Keywords: SST (SystemSuitabilityTest), DAD (Diode Array Detector), ARGUS, Wavelength accuracy, Wavelength resolution, Stray Light, IQ (Installation Qualification), OQ (Operation Qualification), PQ (Performance Qualification), PV (Performance Verification), FDA (Food and Drug Administration), Pharmacopoeia/Pharmacopeia (USP, EP, etc.) [P], GxP (GLP, GMP, etc.), ISO (International Organisation of Standardisation), IUPAC (International Union of Pure and Applied Chemistry), NIST (National Institute of Standards and Technology), ASTM (American Society for Testing and Materials), NNIR (Near Near Infra Red), MCA Multi Component Analysis), RFE (Relative Fit Error), OLS (Ordinary Least Square), ML/H (Maximum Likelihood), PLS (Partial Least Square analysis), PCA/PCR (Principal Component Analysis/Regression). Introduction Spectrophotometry is widely used in industrial quality control and is becoming a very important tool in production, including stoichiometric adjustment, kettle charging and end-point determination, for example. The reliability of the instrumentation and results must therefore be verified under the guidance of ISO, Pharmacopoeia, GLP, GMP and other organisations. The recommended procedure is called the System Suitability Test (SST). Chemometric algorithms, such as MCA, PLS, PCA, PCR, combined with the latest diode array spectrophotometer generation, provide the required powerful tools for quality and production control tasks. At the same time, SST's are still performed in the traditional way. However, the requirements such a test has to fulfill today for a diode array spectrometer cannot be met, particularly where present day chemometrics is used. For example, performing Multi Component Analysis (MCA), [1, 18], with reference and sample spectra measured at different times, while in the meantime the spectrophotometer wavelength has drifted by 3 nm (half the acceptable value in the visible range, [2]), will result in completely meaningless concentrations and quality parameters of the analysis. Also using the stricter limits of the US Pharmacopoeia, [3], does not even give more reliable results. An important sentence from the paper: By spending only ten seconds every 24 hours for carrying out the new SST, much more is achieved — apart from the paperwork — than what IQ, OQ, PQ, and PV can ever do together, for correct and reliable results in the daily routine work. | ||||||||
| References [P] "In correct Latin: Pharmacopoeia" [1] "Matrix Representations and Criteria
for Selecting Analytical Wavelengths for Multicomponent Spectroscopic
Analysis", [2] "European Pharmacopoeia 2003", 2.2.25, Absorption spectrophotometry Ultraviolet and Visible. www.pheur.org [3] US Pharmacopoeia XXVII, 2003, Physical
Tests, 851 Spectrophotometry and Light Scattering, [4] "Hewlett-Packard HP 8452a UV-Visible Spectrophotometer
(190-820 nm Version)” [5] "Hewlett-Packard HP 8453 UV-Visible Spectrophotometer Reference Manual”, May, 1995. www.agilent.com [6] "Hewlett-Packard Operational Qualification / Performance Verification for HP 8453 UV-Visible Spectrophotometer”, September, 1996. www.agilent.com [7] Holmiumoxide solution in perchloric acid with certificate,
SRM 2034 from NIST, National Institut of Standards & Technology, www.nist.gov [8] Holmiumoxide glass filter with certificate, SRM 930e from
NIST, National Institute of Standards & Technology, www.nist.gov [9] "Glass Filters as a Standard Reference Material for Spectrophotometry,
Selection, Preparation, Certification, Use, SRM 930", [10] A.Savitzky, M.Golay, Analytical Chemistry Vol. 36, 8, 1964 1627ff, BUT YOU HAVE TO CORRECT THE FORMULA AND THE IMPLEMENTATION. [11] "Liquid Absorbance Standards", R. W. Burke, E.
R. Deardorff & O. Menis, [12] "Standard Practice for Describing and Measuring the Performance of Ultraviolet, Visible, and Near Infrared Spectrophotometers", American Society for Testing and Materials, E 275-83, Annual Book of ASTM Standards, 1983. www.astm.org [13] "A Wavelength Standard for Ultraviolet-Visible-Near
Infrared Spectrophotometry", J. McNeirney & W. Slavin, [14] "Standards for Checking the Calibration of Spectrophotometers (200 to 1000 nm)", NBS, Letter Circular LC-1017, Jan. 1955, re-issued 1967, in NBS Special Publication 260-51. [15] "Standard Reference Materials: Metal-on-Quartz Filters as a Standard Reference Material for Spectrophotometry - SRM 2031", NBS Special Publication 260-68. [16] "ASTM Standard Method of Estimating Stray Radiant Energy, E 387-72", Reprinted from the Annual Book of ASTM Standards, in NBS Special Publication 260-51. www.astm.org [17] "Techniques in Visible and Ultraviolet Spectrometry
Volume 1 : Standards in Absorption Spectrometry", [18] "Near
Near Infrared Spectroscopy for Quantitative and Qualitative Quality Control”,
Tamzin A. Lafford, |
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Peter Forster:
  
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Software Development & Consulting Peter Forster Neubadstrasse 88 CH-4054 Basle, Switzerland Mail to: peter.forster@p-forster.com |
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