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SOP on Calibration of Halogen Moisture Balance

  • Objective:To lay down the Calibration Procedure for Halogen Moisture Balance.
  • Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Mettler Toledo.

  • Responsibility
    • Trained worker / Operator shall be responsible for operating of the equipment as per this SOP.
    • Production Supervisor / Officer shall be responsible for implementation of this SOP.
    • Head-Production / designee shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

SOP – Standard Operating Procedure

gm – gram

QA – Quality Assurance

  • Procedure
    • Balance Calibration for Halogen moisture Balance
      • Check that the pan is cleaned and dry. Close the balance by pressing ‘’key. Then check the spirit level and adjust to zero level.
      • Switch on the instrument and allow it to stabilize for 2 minutes. When the balance display ‘0.000 gm’. Press ‘menu’ w.cal: No display. Press ‘∆’ key to get ‘yes’ display then press enter key.
      • Display shows w.cal: 50.000 gm and pan comes out automatically. Place 50gm standard weight at the centre of the pan calibration starts automatically. After few seconds, w.cal: 0.000 gm displays remove the weight from the pan again. The instrument displays 0.000 gm.
      • Place 50 gm standard weight at the centre of the pan display shows actual weight.
      • Acceptance criteria for 50 gm standard weight, the measured weight shall be 50.000 ± 0.025 gm.
      • Fill the Calibration Record as per the Annexure-I.
    • Temperature Calibration of Halogen Moisture Balance:
      • Temperature of Halogen Moisture balance will calibrate in two steps 1st point Temperature Calibration and 2nd point temperature calibration.
        • 1st Point Temperature Calibration:

5.2.2.1.1  Press Menu Key, Display will show

 Menu

Temperature Calibration  :No.

5.2.2.1.2    Press ^ & v Key for Select Yes. Display will show

Menu

Temperature Calibration: Yes.

5.2.2.1.3    Press ‘ Enter ’ Key to start the temperature calibration.

5.2.2.1.4    Remove the sample pan holder from the automatic sample

chamber.

  • Place the temperature calibration kit for Halogen Moisture Balance in the sample pan chamber.
  • Press ‘start’ key to start the temperature calibration process.
  • Temperature of heating module in Halogen Moisture Balance will go to 100°c with in 15 minute.
  • At the end of this time a continuous audio signal sound shall come and display of temperature calibration kit shall show correct temperature.
  • Value of temperature shall be recorded in Temperature Calibration Record of Halogen Moisture Balance.

5.2.2.2     2nd   Point Temperature Calibration:

5.2.2.2.1   Press ‘Enter’ key.

5.2.2.2.2   Temperature in Display shall reach up to 160°C.

5.2.2.2.3    Temperature of balance shall reach 160°C with in 15 minute.

  • Correct temperature of Halogen Moisture Balance shall be checked display of Temperature Calibration Kit.
  • Value of temperature shall be recorded in Temperature Calibration Record of Balance.
  • After completion of calibration affix ‘CALIBRATION StATUS’ label duly filled and signed on the instrument.
  • Frequency: Calibration shall be done once in a month or after every repairing work on it.
  • Forms and Records
    • Balance Calibration Record –  Annexure-I
    • Temperature Calibration Record – Annexure-II
  • Distributions
    • Master Copy – Documentation Cell (QA)
    • Controlled Copies – Production and Quality Assurance
  • History
Date Revision

Number

Reason for revision
00 New SOP

 Annexure-I

                               Calibration of Halogen Moisture Balance

 

Equipment I.D. No.

Date of Calibration:                                          Calibration Due Date:

Duration: Six Month

Actual weight 50.0 gm Observed weight

Limit ±0.025

Status

OK/NOT OK

Done By
 

 

 

 

 

 

 

 

 

Calibrated By/Date:                                                               Approved by/Date

 

                                                        Annexure-II

                              TEMPERATURE CALIBRATION RECORD

S.No. Date Time 1st Point temperature calibration Date Time 2 nd Point temperature calibration Status
OK/Not OK
Due Date Done by Checked by
Set value 100 °C Observed value 100 ±6°C Set value 160 °C Observed value 160 ±6°C

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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