Validation of uv visible spectrophotometer.pptx

Validation of UV-Visible spectrophotometer.
It includes installation qualification , design qualification, operational qualification, performance qualification.

1. Validation of uv visible spectrophotometer Presented by: Anupama.cp 1 sem M- Pharm Pharmaceutical analysis

2. INSTALLATION QUALIFICATION The purpose of IQ is to check the installation site/ environment confirms equipment specifications and verifies the condition of installed equipment. IQ protocol shall include the following: Confirmation of the specifications of the analytical equipment Confirmation and maintenance of documents. Confirmation of installation site and conditions. Confirmation of delivered equipment.

3. Installation procedure: While the UV instrument was shipped after the precise adjustment and inspection at the factory, it is recommended to install according to the following procedures so as to provide its optimum performance and to meet the user’s demands. Installation site: Room temperature during use of 15 to 35 degree Celsius. Out of direct sunlight. No strong vibration or continuous weak vibration.

4. No strong magnetic fields electromagnetic fields. Humidity of 45 to 80%. No corrosive gases or inorganic or organic gases with absorptivity in the ultraviolet range. Small amount of dust.

5. Acceptance criteria: REPEATABILITY OF WAVELENGTH ±0.1nm APPEARANCE NO DEFECT NUMBER OF PARTS NO MISSING PARTS ROM CHECK LATEST VERSION LINEARITY OF ABS 0 ±0.002Abs NOISE LEVEL Noise width: ±0.002Abs ACCURACY OF WAVELENGTH ±0.5nm ITEM TO BE CHECKED SPECIFICATION

6. DESIGN QUALIFICATION Documented evidence which shows that the plant designs agrees with the design specification of the customer. OPERATIONAL QUALIFICATION Documented evidence which shows that all parts of the plant and equipment work within their specification and process parameter.

7. PERFORMANCE QUALIFICATION The objective is to ensure that the instrument is performing within specified limits. PQ represents the final qualification of the equipment or system. Wavelength Stray light Resolution Photometric accuracy Noise Baseline fitness Stability

8. Wavelength accuracy It is defined as the deviation of the wavelength reading at an absorption band or emission band from the wavelength of the band. Test: wavelength accuracy verification is checked by comparing the recorded wavelength of the peak against the value of reference standard . Acceptance: + or – nm in the UV range(200-400nm) + or –nm in the visible range (380-800nm) 3 repeated scans of the same peak should be with in + or -0.5nm

9. Stray light It is defined as the detected light of any wavelength that is outside the band width of the wavelength selected. Test : 3 test solution prepared and measured stray light at 200nm,220nm, & 340nm

10. Acceptance : transmittance of the solution in a 1cm cell should be less than 0.01 or the absorbance value should be greater than 2 SPECTRAL RANGE MEASUREMENT WAVELENGTH 175-200 200 210-260 220 300-380 340

11. Resolution power It is the related to its spectral band width The smaller the spectral band width, the linear the resolution. Spectral band width depend on the slit width and the dispersive power of the monochromator . Acceptance : ratio of absorbance at 269nm and 266nm should be greater than 1.5.

12. Noise Noise in the measurement affect the accuracy at the ends of the absorbance scale. Test : air scanned in absorbance mode for 10min, peak to noise is recorded at 800nm.RMS value is calculated. Acceptance: RMS noise should be less than 0.001AU.

13. Baseline flatness The flat baseline test demonstrate the stability of the instrument to normalize the light intensity measurement and the spectral output at different wavelength through out this spectral range . Test: Air scanned in absorbance mode . The highest and lowest deflecction in the absorbance unit are recoreded . Acceptance: Deflection is typically less than 0.01AU

14. Stability The lamb intensity is a function of age of lamb, temperature fluctuation and wavelength of the measurement. This changes can lead to errors in the value of measurement, over and extended period of time . Test: air is scanned in absorbance mode for 60min at specific wavelength (340nm) . The highest and lowest deflection in absorbance unit is measured. Acceptance: deflection is less than 0.002AU/h

15. Photometric accuracy Photometric accuracy is determined by comparing the difference between the measured absorbance of reference material and established value. Test: either neutral density filters or potassium dichromate solution are used Acceptance: 6 repeat measurement of 0.006% w/v potassium solution at 235,257,313 and 350nm should be less than 0.5%RSD .

16. References https://WWW.Slideshare.net/himajadonuthula/qualification -of-infrared-spectroscopy-by- himajad https;// WWW.Slideshare.net / dhawal-Raghv vanshi /qualification –of- analytical - equipments