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QC SOP

SOP Title: Operation, Cleaning and Calibration of Muffle Furnace

SOP Title: Operation, Cleaning and Calibration of Muffle Furnace

  1. Objective:

To lay down the procedure for Operation, Cleaning and Calibration of Muffle Furnace.

  1. Scope:

This SOP is applicable for Operation, Cleaning and Calibration of Muffle Furnace located in Quality Control Laboratory

 

  1. Responsibility:
  • Quality Control: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Muffle Furnace as per this SOP.
  • Engineering Department: To carry out preventive maintenance as per schedule and procedure defined.
  • Quality Assurance Department: To review and approve the SOP and Annexures.

 

  1. Accountability:

Head Quality Control Department, Head Quality Assurance Department.

 

  1. Procedure:

 

    5.1 Safety Precautions/Instructions:
5.1.1 Ensure all the electrical connections are properly earthed. Ensure the power plug of the muffle furnace is fixed in the socket properly.  
5.1.2 Wear personal protective equipments such as safety glasses, heat resistant gloves during operation of equipment.  
5.1.3 Ensure that the ON/OFF switch is working properly by switching “ON” the muffle furnace.             
    5.2 Operation:
5.2.1 Switch ON the main switch.  
5.2.2 The main indicator red light and yellow light will glow and the temperature panel display will show the temperature in o C.  
5.2.3 Set the required temperature on the digital temperature controller by pushing red key present at the left side of “Temp. SET” knob and rotating the “Temp. SET” knob.  
5.2.4 Relieve the red key button after the required temperature is set.  
5.2.5 Move the “Energy Regulator” knob clockwise to corresponding temperature.  
5.2.6 Wait till the temperature controller display shows the set temperature.  
5.2.7 Open the door of the muffle furnace by pushing the lever upwards and place the crucible containing sample inside the muffle furnace with the help of long pair of tongs.  
5.2.8 Immediately close the door.  
5.2.9 Allow the substance under test to remain inside muffle furnace at a specified temperature and specified time as mentioned in the respective pharmacopoeia or specification.  
5.2.10 After completion of analysis, Switch OFF the mains of the muffle furnace.  
5.2.11 Open the door of the muffle furnace, remove the crucible containing sample and place it in desiccator till it attains the room temperature.  
5.2.12 Immediately close the door of the muffle furnace.  
5.2.13 Update the “Instrument/Equipment Usage Log Book” as per SOP “Calibration of Instruments and Equipment’s”.  
5.3 Cleaning Procedure:
5.3.1 Switch OFF the mains of the muffle furnace.  
5.3.2 Ensure that the temperature of the muffle furnace is nearly at room temperature when cleaning inside.  
5.3.3 Clean the inside and outside of muffle furnace with lint free cloth or soft brush before and after use.  
5.4 Calibration Procedure:
  Frequency:  Once in a year by external agency.
5.4.1 Calibration is carried out by external agency as per SOP “Calibration of Instruments and Equipment’s”.  
5.4.2 Refer Annexure for calibration test to be performed and acceptance criteria.

Sr. No. Tests Set value Acceptance Criteria

(± 2%)

1. Temperature Verification 200oC ± 4oC
400°C ± 8oC
800oC ± 16oC
1000oC ± 20oC
1100oC ± 22oC
 
5.4.3 Generate the A. R. No. on the “Instrument/Equipment Calibration Register” as per SOP and give requisition to QA department for calibration formats of instruments/equipments on the due date of calibration.  
5.4.4 For issuance of calibration report refer SOP “Control of documents, Preparation, Approval, Issuance and Maintenance.  
5.4.5 Update “Annual Calibration Schedule” and “Monthly Calibration Schedule” as per SOP “Calibration of Instruments and Equipments”.  
5.5 Preventive Maintenance:
5.5.1 Perform the preventive maintenance as per define Annexure.  
5.5.2 If preventive maintenance activity is outsourced, the observations are to be transcribed in the Annexure and external party certificate to be attached.  
5.5.3 If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”.  

 

  1. Definitions / Abbreviations:
  • Definitions:
  • Calibration: Tests performed to ensure that the instrument/equipment is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
  • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.
  • Abbreviations

 

Abbreviation Expansion
SOP Standard Operating Procedure
QC Quality Control
QA Quality Assurance
A. R. No Analytical Reference Number
No. Number
oC Degree Celsius
PM Preventive Maintenance

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

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