This document details the procedure for the operation and calibration of the Photofluorimeter. This SOP is applicable at the time of the operation and calibration of the Photofluorimeter.
It is the policy of XYZ Pharmaceuticals Limited that a written procedure shall be followed for the operation and calibration of the Photofluorimeter to ensure smooth operation and its use monitored to obtain consistent and reproducible results minimize downtime and meet regulatory requirements.
RESPONSIBILITY AND ACCOUNTABILITY
Persons
along with their responsibilities and accountability are given below:
Executive
- Corporate Quality Assurance:- To prepare the SOP
Trainee
Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly
Vice President – Technical:- To
ensure implementation of SOP.
Operation and Calibration of Photofluorimeter
Cleaning Procedure for Tube
Never
use a brush to clean the tube of the Photofluorimeter. Clean the tube using the
purified water or any organic solvent (i.e. acetone or methanol). Add about 1
ml of the solution to be measured. Tilt and turn the tube so that the solution
has contact with the entire surface. Discard the solution and repeat this rinse
once more.
5.1.4 Wipe
the outside of the tube with a lint-free, soft tissue to remove any moisture or
fingerprints from the outside surface
5.2 PRECAUTIONS for Photofluorimeter
5.2.1 Allow the instrument to warm
up for 30 minutes before use.
5.2.2 Switch “ON” the instrument and see if the neon lamp on the front panel is
glowing or not.
5.2.3 Check if the cooling fan is running or not.
5.2.4 Avoid handling the lower part of the sample tube.
5.2.5 Clean the primary and secondary filters properly with the lint-free cloth.
5.2.6 Each measurement requires a minimum of 4 ml of sample solution.
Test
tubes must be inserted in the sample holder with the index mark (or trademark)
directly facing the operator
5.3 OPERATION Photofluorimeter
5.3.1 CONNECT THE INSTRUMENT WITH THE MAIN
POWER SWITCH.
5.3.2 Set the “standard coarse” control and the “blank coarse” control to a minimum
i.e. counterclockwise.
5.3.3 Insert appropriate “primary” and “secondary” filters on their respective slots.
5.3.4 Switch on the instrument. Check if the cooling fan is running this can be
noticed by slight noise from the fan and the flow of air from the perforated
sheet at the back.
5.3.5 Keep the instrument “ON” and allow a warm-up period of 30 minutes before use.
5.3.6 Wash, rinse, and fill the test tube with a blank solution.
5.3.7 Keep the test tube in the sample holder of the instrument.
5.3.8 Match the test tube mark with the mark in the sample holder.
5.3.9 Close the shutter.
5.3.10
Push the button marked “TO READ” and set the pointer approximately at “ZERO”
5.3.11 Insert
the tube containing the standard solution of known concentration into the
sample holder.
5.3.12 Push the button “TO READ” and set the meter reading to 50 (or as per concentration)
using the standard Knob.
5.3.13
Take the readings in triplicate repeating the above procedure.
5.3.14
Replace the standard solution with the blank solution and note the meter
reading.
5.3.15
Replace the blank solution with the unknown solution (sample solution) and
note the reading in triplicate repeating the above procedure
5.3.16
Blank reading must be subtracted from the standard and the unknown sample
before comparison.
5.3.17
Switch off the instrument after use
5.3.18
Calculate the concentration, Cx of the substance in the
solution to be examined, using the expression. Cx = Ix X
Cs
Is
Where
Cx = Concentration of the solution to be examined
Cs =
Concentration of the standard solution
Ix =
Intensity of the light emitted by the solution to be examined
Is =
Intensity of the light emitted by the standard
solution
5.3.19
Maintain Logbook of Photoflourimeter as per XYZ/CQA/SOP-063/FR-01, Logbook for Photofluorimeter
Appendix I.
6.0 Calibration of Photofluorimeter
6.0.1 Calibration Frequency: Quarterly
6.0.2 Before attempting calibration the photofluorimeter must be switched “ON” for at
least 20 minutes.
6.0.3 Weigh accurately about 50 mg of Quinine Sulphate and dilute it up to 500 ml
with 0.05M Sulphuric acid (Solution A).
From
Solution A prepare the solution of different concentrations in 0.05 M sulphuric
acid as per the following table
|
Solution |
Vol. of Solution A taken (mL) |
Makeup to (mL) |
Final concentration (ppm) |
|
B |
1 |
100 |
1 |
|
C |
2 |
100 |
2 |
|
D |
3 |
100 |
3 |
|
E |
2 |
50 |
4 |
|
F |
5 |
100 |
5 |
|
G |
2 |
25 |
8 |
Set
the instrument to read 50 on the scale with 8ppm (solution G) Quinine Sulphate
solution.
Take the reading in triplicate and record the calibration data on XYZ/CQA/SOP-063/FR-02
as Calibration Datasheet Appendix II (page 1 of 1).
Similarly,
record the reading in triplicate for the remaining solutions (from solution B
to F) of the Quinine Sulphate solution.
Plot
a graph of concentration v/s average of the readings taken. The graph should be
linear and the coefficient of correlation should be close to 1.
After
the calibration of the Photofluorimeter affix a calibration sticker on the
instrument as per XYZ/CQA/SOP-006, Labelling policy, and fill in all the
required details.
Ensure
the power supply to the instrument is switched “OFF” before clearing. Clean the
instrument with a clean dry swab every day.
6.0.11 Report
any discrepancy observed during the operation and calibration of the instrument. To
Section In-charge or his representative for corrective and preventive action.
6.0.12
Section In-charge or his representative will take the necessary action and
report the same to the Manager – Quality Assurance.
6.0.13
Affix the ‘Out of Order’ label on the Photoflurimeter.
7.0 GENERATION
OF INSTRUMENT CALIBRATION NUMBER
Generate
the instrument calibration number on the calibration datasheet as INSCALXXYYZZZ
where INS denotes instrument, CAL denotes calibration, XX denotes the year, YY
denotes month and ZZZ denotes sequence number.
8.0 ABBREVIATION
XYZ
XYZ Pharmaceuticals Limited
CQA
Corporate Quality Assurance.
QA
Quality Assurance
SOP
Standard Operating Procedure
>Operation and Calibration of the Polarimeter
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