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CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER (METLER – TOLEDO)

  • OBJECTIVE: To lay down the procedure for calibration of Halogen moisture analyser,Make-  Metler – Toledo.
  • SCOPE: This SOP shall provide the calibration procedure of Halogen moisture analyser in in-process quality assurance  department and quality control department.
  • RESPONSIBILITY :Officer/ Executive – Quality Control/Quality Assurance.
  • ACCOUNTABILITY:Head QC/QA
  • PROCEDURE:
  • Precautions:
  • Before starting the operation check for the area cleanliness and instrument cleanliness.
  • The air bubble level of the indicator should be in the center or else is adjusted by the screws provided at the bottom of the balance.
  • After drying as the pan and sample may still be hot, let these cool off before removing the pan from the sample holder.
  • Weight taken should be more than 0.5g and less than 20g.
  • Operate the instrument as per sop.
  • The Instrument is calibrated for following parametersa) Balance Calibration
  1. b) Moisture Content repeatability with five replicates
  2. c) Temperature
    • Balance Calibration:

      • Press “MENU” key and select calibration mode by pressing “ / ” keys.
      • Press the <<Accept entry >> key (8 ) to start the balance calibration.
      • The display flashes “50.000” g requesting to place 50.000g standard weight on the weighing pan.
      • Place the 50.000g standard certified weight in the middle of the weighing pan. Instrument automatically calibrates itself and flashes 0.000 gm on display, indicating that the balance has been calibrated.
      • The instrument stores the determined weight value and the display prompts to lift off the standard weight from the weighing pan.
      • Remove the standard weight from the weighing pan and the displays “DONE”.
      • Display returns back to the main screen.
      • Master formula of Iron, Folic Acid, Vitamin B12 and Calcium Carbonate Capsules (drugsformulations.com)

  • Now the balance is internally calibrated with external standard weight.
  • Verify the calibration by placing the 50.0 g weight again on the pan and record the reading.
  • The weight observed should fall with in the tolerance limit of 50.000 ± 0.01 g.
  • Moisture Content Repeatability Test:
  • Operate the instrument as per sop.
  • Add 2 g Chemical substance “Disodium tartrate dihydrate” by distributing as evenly as possible on the sample pan.
  • Press the temperature adjusting key. Set the temperature to 130.0°C by using the  /  keys.
  • Set the time key to “3”, the factory setting.
  • Close the heating module, the status displays which indicates the drying of the sample and the system will automatically start the drying and measuring process.
  • Record the moisture content observed.
  • The test is carried out for five replicates and the RSD is calculated.
  • Temperature Calibration:
  • Temperature Calibration of the instrument is carried out by external agency at 100°C and 160°C using temperature  adjustment set.
  • After usage of the instrument, maintain the record in the user logbook.
  • If the instrument does not meet the acceptance criteria, tag the instrument as “OUT OF CALIBRATION” and inform the service engineer and tag the instrument with “UNDER MAINTAINENCE”.
  • Acceptance Criteria:
Calibration Parameter Acceptance Criteria Frequency
Balance Calibration 50.000g  ± 0.01g Monthly and after any maintenance job
Moisture Content repeatability with five replicates. Moisture Content = 15.66 ± 0.5 %

RSD: NMT 0.3%

Monthly and after any maintenance job
Temperature Two point calibration done by external agency for 100°C ± 2°C and 160± 2°C Yearly and after any maintenance job
  • Forms and Records
    • calibration format for Halogen Moisture Analyzer-Annexure-1
  • Distribution
    • Master Copy – Documentation Cell (Quality Assurance)
    • Controlled Copies – Quality Control, Production, Quality Assurance.
  • History
Date Revision Number Reason for Revision
00 New SOP

 

Annexure -I

Calibration format for Halogen Moisture Analyzer

Make : Instrument No. :
Model : Calibration Date :
Reference SOP No. : Next due date :
Cleanliness of equipment / instrument before calibration:
1 . BALANCE CALIBRATION:
Standard weight box ref.no:
S.No Check weight Standard Mass value Displayed wt. Limit Remarks
1 50.000 g ± 0.01 g
2
 2. MOISTURE CONTENT REPEATABILITY:
 Standard Di Sodium Tartrate used ( B. No. / Lot No._______________________ ) 
S.No Sample replicate number Observed Moisture content Results Limit Remarks
1 MEAN VALUE: 15.66 ± 0.5 %
RSD: NMT 0.3%
2
3 STD.DEV:
4
5 RSD:
Temperature Calibration (by external agency):                                
Temperature adjustment device ref.No  :
S.No Set Temperature Observed Temperature Limit Remarks
Instrument Temp.adjust.device
1 100°C 98 – 102°C
2 160°C 158 – 162°C
CALIBRATION STATUS: COMPLIES / DOES NOT COMPLIES

Calibrated by:                           Checked by:                                           Approved by  :

Date      :                                     Date       :                                                       Date               :   

 

 

MASTER FORMULA OF VITAMIN B-COMPLEX CAPSULES (drugsformulations.com)

 

 

 

 

 

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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