Qualification of UV spectrophotometer

in this slide contains Qualification of UV spectrophotometer
presented by: G.CHIRANJEEVI (Department of pharmaceutical analysis).RIPER, anantapur

1. 1 Qualification of UV Spectrophotometer A Seminar as a part of curricular requirement for I year M. Pharm II semester Presented by Mr . G. Chiranjeevi (Reg. No. 20L81S0706) Department of Pharmaceutical Analysis

2. 2 Introduction Qualification of UV-Vis Spectrophotometer DQ of UV-Vis spectrophotometer IQ of UV-Vis spectrophotometer OQ of UV-Vis spectrophotometer PQ of UV-Vis spectrophotometer References Contents

3. 3 Qualification: Action of proving and documenting that any equipment, utilities, and systems actually and consistently leads to the expected results Qualification should be completed before process validation is performed. stages of qualification Design qualification(DQ) Installation qualification(IQ) Operational qualification(OQ) Performance qualification(PQ) Introduction

4. 4 Design qualification(DQ) Documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of GMP. Installation qualification (IQ) Installation qualification should provide documented evidence that the installation was complete, satisfactory and operate in accordance with established specifications.

5. 5 Operational qualification (OQ) Operational qualification should provide documented evidence that utilities, systems or equipment and all its components operate in accordance with operational specifications Performance qualification (PQ) Performance qualification should provide documented evidence that utilities, systems or equipment and all its components can consistently perform in accordance with the specifications under routine use. Test results should be collected over a suitable period of time to prove consistency.

6. 6 Qualification of UV-Vis Spectrophotometer

7. 7 Supplier must provide documented evidence that the product has been designed, developed and manufactured in a quality environment e.g. ISO 9001:2000 certification. Supplier must provide on-site support in case of defects. Supplier must provide information through the internet on availability of new firmware upgrades. Design Qualification Feature Consideration Instrument set-up and control Pc based or integrated system. Software control of operating conditions and parameters. In-built diagnostic facilities. Self-testing diagnostics. Detector options .

8. 8 Feature Consideration Sample introduction and throughput Sample throughput, presentation and introduction needs. Sample volume requirements. Installation requirements Size and weight in shipped form. Access restrictions to permanent site. Operational requirements Limitations on requirements for and expected consumption of services, utilities, and consumables (e.g. lamps). Ventilation requirements. Controlling software embedded or separate package.

9. Installation Qualification The instrument has been delivered as ordered , e.g purchase order. The instrument has been checked and verified as undamaged. The appropriate documentation has been supplied and it is of correct issue and uniquely identified by part number , version number and date. Intervals , methods and instructions for user-maintenance and calibration document have been provided along with contact points for service and spare parts. The correct hardware, firmware and software have been supplied and it is of correct issue and uniquely identified by part number .

10. 10 Information has been provided on consumables required during the normal operation of the instrument. The selected environment for the instrument system is suitable, with adequate room for unpacking, installation, operation and servicing, and have appropriate services and utilities have been provided. Cont…

11. 11 Test procedure Acceptance limits Test frequency Remarks Wavelength maxima of 1.4M holmium perchlorate solution is measured at 241, 287, 361 and 536 nm. ±1 nm in UV range ± 3 nm in visible range Six months Standard is traceable to national standard. Operational Qualification Wavelength accuracy- 1.4M holmium perchlorate solution Test procedure Acceptance limits wavelength A 1%/1cm Limits Absorption of potassium di chromate solution is measured 235 (min) 257 (max) 313 (min) 350 (max) 124.5 144. 5 48.6 10 7 . 3 122.9 - 126 . 2 142.4 - 145 . 7 47.0-50.3 104.9 - 108 . 2 Absorption intensity

12. 12 Test procedure Acceptance limits Test frequency Absorption of 1.2% potassium chloride solution at 200 nm is measured against water. Absorption at 200 nm >2.0 AU Six months Stray light Test frequency :- six months Remarks :- Standard is traceable to national standard. Remarks :-Alternative standards: Sodium nitrite Sodium iodide. 12 Maximas of holmium perchlorate Stray light test with 1.2% KCl

13. 13 Test procedure Acceptance limits Transmission of cuvette (water) against air. a) Quartz cuvettes: 85% at 220 nm 88% at 240 nm b) Glass cuvettes: 85% at 356 nm 88% at 650 nm Control of cuvette Test frequency :- six months Remarks :- Standard is traceable to national standard. Test procedure Acceptance limits Test frequency Spectrum of toluene is measured from 260 to 275 nm. Ratio of peak height to valley is calculated. Absorbance ratio peak to valley at 266/269 nm > 1.5 Six months Wavelength resolution

14. Performance Qualification Parameter Reason Procedure Wavelength calibration Critical to accuracy of results. Can be determined using only two calibration wavelengths, preferably bracketing the analytical wavelength. Photometric accuracy Critical to accuracy of results Can be determined for particular absorbance at particular wavelengths using calibrated filters or cuvettes filled with standard solutions. Critical to accuracy of results Can be determined by checking the accuracy of a number of normal absorbances across the desired absorbance range. Extrapolation beyond highest standard is inadvisable. Linearity in photometric response

15. 15 Parameter Reason Procedure Signal to noise ratio Important for sensitivity a nd limit detection Can be determined from the response of a detector to a dilute standard solution and/or a blank. Stray light Important measure of healt h of whole system Record uncorrected spectrum in single beam mode for double beam instruments or with baseline correction switched off for single beam instruments. Cont…

16. 16 Parameter Reason Procedure Importance for precise and accurate measurement of peaks including partially resolv e d, br o ad a n d asymmetric peaks- does it do its sums properly? Is the software fully and correctly loaded? Does manipulation and storage corrupt the raw data? Can be determined and verified using software packages or using reference materials. Where instruments are designed to accept checking using datasets, these should be used . Absorption Important for accuracy and precision of results, checks that the optical faces of the cell are parallel. Can be determined by filling the cell with water, measuring at required wavelength(s), using air as the reference and repeating the process after rotating the cell through 180°. Cont… Software accuracy and Precision, derivatives

17. 17 1. Ultraviolet and visible absorption spectrophotometry, I.P 2007, Vol 1, 2.4.7 , Pg. no 112-114. 2. Qualification of UV-Visible spectrophotometers PA/PH/OMCL (19) 100 R1, Quality Management Document, EDQM, 2020. 3. David Rudd, Qualification of analytical equipment, method validation in pharmaceutical analysis, part II (4 th chapter ), 2005. 4. B . Gouthami, Gattu Venkateshwarlu, Calibration and Validation of HPLC , GC, & UV-VIS spectroscopy, international journal of modern chemistry and applied sciences 2014,1(4), 2-4 . References

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