STANDARD OPERATING PROCEDURE Operation and Calibration Procedure of pH Analyzer
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STANDARD OPERATING PROCEDURE |
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Department: Quality Control
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SOP No.: QC/MB/
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Operation and Calibration Procedure of
pH Analyzer
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Effective
Date:
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Review
Date:
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Page
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1.0
OBJECTIVE:
1.1
To lay down a procedure for operation and calibration of pH analyzer.
2.0
SCOPE:
2.1
This procedure is applicable to pH analyzer located in microbiology
laboratory at Pharma Private Limited.
Instrument ID No.
Make: Lab India
Model:
3.0
RESPONSIBILITY:
3.1
Microbiologist/QC designee – Responsible for Operation and calibration of pH Meter.
3.2
Section In-charge – Responsible
for review the procedure and reports.
3.3
QC Head – Responsible for implementing the Procedure.
3.4
QA Head – Overall compliance.
4.0
PROCEDURE:
4.1
Operating
procedure:
4.1.1
Ensure that the instrument is clean and free from
dust.
4.1.2
Ensure that the plug is connected to the mains.
4.1.3
Switch on the power.
4.1.4
Connect Flat and reference / combined electrode to the
appropriate terminals at the rear panel.
4.1.5
The display will show commonly LAB INDIA PICO V2.16 pH Meter.
4.1.6
Measuring
procedure of pH:
4.1.6.1 Clean
electrode with distilled water.
4.1.6.2 Place the
electrode and temperature sensor in sample.
4.1.6.3 Press
“MODE” key followed by “ENTER” key.
4.1.6.4 Now the
display will show the pH of the test solution.
4.1.6.5 Now press
the “ENTER” key to save the pH value.
4.1.6.6 After
checking all samples press “RESET” key to go to common display.
4.1.6.7 After usage
of pH meter enter the usage details in Annexure II.
4.2
Standardization
and Calibration Procedure:
4.2.1
STANDARDISATION
PROCEDURE:
4.2.1.1 Press
“MODE” key followed by “ENTER” Key.
4.2.1.2 Then Press
“CAL” key and followed by “ENTER” key.
4.2.1.3 Now the
display will show Calibration Mode, 1>Standardization 2> Calibration.
4.2.1.4 Select
standardization by pressing 1 and followed by “ENTER” key.
4.2.1.5 Now the display
will show “Use Buffer (6.8 -7.2) Enter
pH= ”.
4.2.1.6 Enter
Buffer value ‘7.00’ and press “ENTER” Key.
4.2.1.7 When mV
reading is stable press “ENTER” Key.
4.2.1.8 Now the
display will show “Calibration over” and
“Calibration, 1>Y 2> N”.
4.2.1.9 Press 1
followed by “ENTER” key to continue the calibration with buffer 4.00.
4.2.1.10 Now the
display will show “Buffer <6.5 or
>7.5 Enter pH= ”.
4.2.1.11 Clean the
electrode & sensor with distilled water and place them in appropriate
buffer solution say pH 4.00.
4.2.1.12 Enter
buffer value 4.00 & press “ENTER” key.
4.2.1.13 When mV
reading is stable press “ENTER”. If reading is within limit instrument will
display Calibration over and Calibration 1> Y 2> N.
4.2.1.14 Press 1
followed by “ENTER” key to continue the calibration with buffer 9.20.
4.2.1.15 Now the
display will show “Buffer >7.5 Enter
pH= ”.
4.2.1.16 Clean the
electrode and sensor with distilled water and place them in buffer solution say
pH 9.20.
4.2.1.17 Enter the
buffer value 9.20 and press “ENTER” key.
4.2.1.18 When mV
reading is stable press “ENTER” key.
4.2.1.19 If reading
is within limit instrument will display “Calibration over”.
4.2.1.20 Then press
“RESET” key to go back to common display.
4.2.1.21 The
acceptance criteria of calibration is based on slope values.
4.2.1.22 Frequency
of calibration: Daily
4.2.2
Slope
observation procedure:
4.2.2.1 Press
“MODE” key followed by “ENTER” key.
4.2.2.2 Now Press
“CAL” key.
4.2.2.3 Now the
display will show the slope values.
4.2.2.4 Enter the
observed slope values in Annexure – I.
4.2.2.5 The
acceptance limit for calibration is slope 80% to120%.
4.2.2.6 Then press
“RESET” key to come back to common display.
4.2.3
Confirmation
procedure of pH buffers (7.00, 4.00 and 9.20):
4.2.3.1 Clean the
electrode & sensor with distilled water and place them in appropriate
buffer solutions say pH 7.00.
4.2.3.2 Press
“MODE” key followed by “ENTER” key.
4.2.3.3 Now the
display will show the pH value.
4.2.3.4 Press the
“ENTER” key to save observed pH value.
4.2.3.5 Enter the
observed pH value in Annexure – I.
4.2.3.6 Clean the
electrode & sensor with distilled water and place them in appropriate
buffer solutions say pH 4.00.
4.2.3.7 Now the
display will show the pH value.
4.2.3.8 Press the
“ENTER” key to save observed pH value.
4.2.3.9 Enter the
observed pH value in Annexure – I.
4.2.3.10 Clean the
electrode & sensor with distilled water and place them in appropriate
buffer solution say pH 9.20.
4.2.3.11 Now the
display will show the pH value.
4.2.3.12 Press the
“ENTER” key to save observed pH value.
4.2.3.13 Enter the
observed pH value in Annexure – I.
4.2.3.14 Then press
“RESET” key to come back to common display.
4.2.3.15 The
observed pH should be 4.00
± 0.05, 7.00 ± 0.05 and 9.20 ± 0.05.
4.3
Preparation of buffer solutions:
4.3.1
pH buffer 4.00: Dissolve pH 4.00 tablet or capsule in
100 mL of purified water.
4.3.2
pH buffer 7.00: Dissolve pH 7.00 tablet or capsule in
100 mL of purified water.
4.3.3
pH buffer 9.20: Dissolve pH 9.20 tablet or capsule in
100 mL of purified water.
4.3.4
Enter the preparation details
of pH buffers in Annexure I of SOP QC/GN/004.
4.3.5
Use the prepared buffer
solutions for one week from the date of preparation.
4.4
Maintenance
of electrode:
4.4.1
Monthly once the electrode
shall be dipped in 0.1M Hydrochloric acid for overnight.
4.4.2
Then remove the electrode from
0.1M Hydrochloric acid and wash thoroughly with purified water and dip in 3 M
Potassium chloride.
4.5
If instrument is out of calibration, then out of calibration shall be
investigated as per current version of SOP QA/GN/027.
5.0
ABBREVIATIONS:
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SOP: Standard Operating Procedure
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QC: Quality Control
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QA: Quality
Assurance
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HCl: Hydro Chloric
acid
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