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

1. Presented by: Anupama.cp
1 sem M-Pharm
Pharmaceutical analysis

2.  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:
i. Confirmation of the specifications of the analytical
equipment
ii. Confirmation and maintenance of documents.
iii. Confirmation of installation site and conditions.
iv. Confirmation of delivered equipment.

3.  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. 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. 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.  The objective is to ensure that the instrument is
performing within specified limits. PQ represents
the final qualification of the equipment or system.
1. Wavelength
2. Stray light
3. Resolution
4. Photometric accuracy
5. Noise
6. Baseline fitness
7. Stability

8. 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. 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.  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 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. 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.  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 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.  https://WWW.Slideshare.net/himajadonuthul
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himajad
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 https;//WWW.Slideshare.net/dhawal-Raghv
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