SOP for Calibration of pH Meters | Pharmaguideline
  •   Pharmaguideline Courses Start Learning
  • Apr 17, 2021

    SOP for Calibration of pH Meters

    Standard operating procedure to calibrate the pH meter using the standard buffer solutions.

    1.0 OBJECTIVE

    To calibrate the equipment for reliable and accurate results.

    2.0 SCOPE

    This procedure is applicable for pH meters installed at Quality control laboratory.

    3.0 RESPONSIBILITY

    3.1 Doing: Technical Assistant
    3.2 Checking: Executive /Manager

    4.0 ACCOUNTABILITY

    Head of the Department

    5.0  PROCEDURE

    5.1 Operate the instrument as per respective Standard Operating Procedure.
    5.2 Use Certified Standard pH buffer to set the instrument at pH 7.00 (with 7.00 pH buffer) and pH 4.00 (with 4.00 pH buffer) at 25oC.
    5.3 Take 100 ml buffer pH 4.0 & pH 7.0 from the Certified buffer bottle in a glass bottle. Discard the Standard pH buffer after one month.
    5.4 Prepare different pH solutions of 0.05 M Potassium biphthalate, 0.05 M equimolol phosphate, 0.01 M sodium tetraborate and Calcium Hydroxide (saturated solution at 25oC)
    5.4.1 Solution A: Preparation of 0.05 M Potassium Biphthalate (pH 4.01)
    Dissolve 10.12 gm. of KHC8H4O( previously dried at 110 oC for 1 hour) in water to make 1000 ml.
    5.4.2 Solution B: Preparation of 0.05 M equimolol phosphate buffer( pH 6.86)
    Dissolve 3.53 gm. of Na2HPO4 and 3.39 gm. of KH2PO4 (each previously dried at 120oC for 2 hour) in water to make 1000 ml.
    5.4.3 Solution C: Preparation of 0.01 M Sodium tetraboarte buffer( pH 9.18)
    Dissolve 3.80 gm.of Na2B4O7.10 H2O in water to make 1000 ml. Protect the solution from absorption 
    of carbon dioxide. 5.4.4 Solution D: Preparation of Saturated solution of Calcium hydroxide at 25oC (pH 12.45).  Shake an excess of calcium hydroxide with water and decant at 25oC before use. Protect the solution from absorption of carbon dioxide. (Prepare fresh solution when required)
    5.5 Check the pH of above buffer solutions. It should be within + 0.07. Record the value in the prescribed Annexure-II 5.6 Check the pH of Certified buffer pH 4.0 & pH 7.0. It should be within +0.02 pH limit of labelled value. Record the value as per Annexure-II
    5.7 Discard buffer solution A, B and C after three months.
    5.8 Frequency of calibration:- 15 days.
    5.9 Daily calibration
    5.9.1 Repeat the same procedure for daily calibration of pH meter using solution A, B and solution C and record value as per annexure-I
    5.10 If it is out of specified limit, follow the S.O.P.

    Related: Principle and Working of pH Probes

    6.0 ABBREVIATIONS

    6.1 oC = Degree centigrade
    6.2 Na2B4O7.10H2O = Sodium Tetraborate Decahydrate
    6.3 U.S.P. = United state pharmacopoeia
    6.4 Na2HPO4 = Disodium hydrogen orthophosphate
    6.5 KH2PO= Potassium dihydrogen orthophosphate
    6.6 gms. = Grams
    6.7 S.O.P.No. = Standard operating procedure number
    6.8 KHC8H4O4  = Potassium Biphthalate


    ANNEXURE-I
    Q. C. Department
     DAILY CALIBRATION RECORD
    Name of  the Instrument     :  pH METER
    Make                                                :  
    Model  No                                      :                                  
    IDENTIFICATION NO.                    :
     ______________________________________________________________________________
    Primary standard : Certified  buffer (pH 4.00 &pH 7.00)
    OBSERVATION CHART
    Date
    0.05 M
    Potassium
    Biphthalate
    ( 4.01+ 0.07)
    0.05 M equimolol
    phosphate
    ( 6.86+ 0.07)
    0.01 M 
    sodium        Tetraborate
    ( 9.18+ 0.07)
    Check point
    ( if applicable)
    Calibrated by
    Checked by



































    ANNEXURE-II
    Q. C. Department
      CALIBRATION RECORD OF pH METER
    Name of  the Instrument    :  pH METER
    Make                                                :  
    Model  No                                     :                                     
    IDENTIFICATION NO.                   :
     _______________________________________________________________________________
    Primary standard : Certified  buffer Primary standard : Certified  buffer (pH 4.00 & pH 7.00)
    Batch No:___________ (pH 7.00)
    Batch No.:__________ (pH 4.00)
    OBSERVATION : 
    Buffer
    Theoretical pH
    Value(At 25oC)
    Observed value
    Tolerance
    Remarks
    0.05 M Potassium Biphthalate
    4.01
    + 0.07
    0.05 M equimolol phosphate
    6.86
    + 0.07
    0.01  M sodium Tetraboarte
    9.18
    + 0.07
    Calcium hydroxide (saturated)
    12.45
    + 0.07
    Standard  Certified buffer
    6.98
    + 0.02
    Standard Certified buffer
    4.01
    + 0.02

    Remarks                              :
    Calibration date                   :                                                                     
    Calibration due date            :
    Calibrated  by                     :
    Checked  by                       :
    Get editable documentsView List

    No comments:

    Post a Comment

    Please don't spam. Comments having links would not be published.


    Popular Categories ๐Ÿท️

    QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy Regulatory Updates
    Online Courses Salary Calculator
    Follow on Whatsapp


    Certificate Courses ๐ŸŽ–️

    Pharmaceutical Courses

    Follow Pharmaguideline


    DOCUMENTS ๐Ÿ“‹

    PHARMACEUTICAL DOCUMENTS




    Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

    View


    adsbypg


    GET APP FOR NEWS UPDATES


    Android App