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QC SOP

SOP Title: Operation, Cleaning and Calibration of Bulk Density Apparatus

SOP Title: Operation, Cleaning and Calibration of Bulk Density Apparatus

  1. Objective:

To lay down the procedure for Operation, Cleaning and Calibration of Bulk Density Apparatus.

  1. Scope:

This SOP is applicable for Operation, Cleaning and Calibration of Bulk Density Apparatus 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 Bulk Density Apparatus 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 bulk density apparatus is fixed in the socket properly.  
5.1.2 Wear personal protective equipment’s such as safety glasses, hand gloves during operation of instrument.  
5.1.3 Ensure that the ON/OFF switch is working properly by switching “ON” the bulk density apparatus.             
  5.2 Operation  Procedure:
5.2.1  Check the validity of Calibration before starting any operations  
5.2.2 Introduction to the Keys:

ON/OFF Mains: To ON and OFF the instrument.

 
5.2.3 Switch ON the main switch of instrument.  
5.2.4 Weigh the required quantity of sample and transfer it into empty clean and dry measuring cylinder.  
5.2.5 Wrap cylinder mouth with aluminium foil or rubber stopper.  
5.2.6 Open the rings of the holder provided on the instrument.  
5.2.7 Place the measuring cylinder on the round surface of the instrument and slightly screw up the rings.  
5.2.8 Set the desired number of strokes by pressing SET key.  
5.2.9 Switch ON the ‘ON/OFF Mains’ button on the instrument.  
5.2.10 The piston will rise up & down till the set number of strokes are completed.  
5.2.11 At the end of the process the burger will indicate for completion of process.  
5.2.12 Switch OFF the ‘ON/OFF Mains’ button and open the rings of the holder and remove the measuring cylinder.  
5.2.13 Switch OFF the main switch of instrument.  
5.2.14 Record the volume and calculate the bulk density of the sample as per standard testing procedure.  
5.2.15 Update the “Instrument/Equipment Usage Log Book” as per SOP.  
   5.3 Cleaning Procedure:
5.3.1 Switch ON the main switch of instrument.  
5.3.2 Clean the surface of the instrument with lint free cloth before and after use.  
5.4 Calibration Procedure:
5.4.1 Frequency: Half Yearly or after carrying out any major maintenance work.
5.4.2 Generate the A. R. No. as per SOP and give requisition to QA department for calibration formats of instruments on the due date of calibration.  
5.4.3 For issuance of calibration report refer SOP.  
5.4.4 Perform the calibration of instrument as per Annexure and procedure mentioned below.  
5.4.5 Switch ON the main switch of instrument.  
5.4.6 Switch ON the ‘ON/OFF Mains’ button on the instrument.  
5.4.7 Set the strokes to 100 by pressing SET key.  
5.4.8 Check the number of strokes on digital display.  
5.4.9 At the end of the process the beep sound will indicate for completion of process.  
5.4.10 Follow the same procedure for 50 strokes.  
5.4.11 Switch OFF the ‘ON/OFF Mains’ button and switch OFF the main switch.  
5.4.12

 

 

 

 

 

 

 

Enter the details in calibration report as per Annexure. Ensure that the results obtained, comply with the acceptance criteria.

Sr. No. Parameters Set value Acceptance Criteria Observed Values  
1. No. of Strokes 50 ± 1 Stroke    
100 ± 2 Stroke  

 

 
 
5.4.13 Update the “Instrument/Equipment Usage Log Book.  
5.4.14 Affix the “Calibration Status Label” on the Instrument as per SOP.  
5.4.15 If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.  
5.4.16 If any breakdown occurs, follow procedure as per SOP.  

  

  1. Definitions / Abbreviations:
  • Definitions:
  • Breakdown: Any activity leading to operation of instrument/equipment other than the set parameters or unusual sound or vibration observed in the instrument/equipment.
  • 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 instrument/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
No. Number
A.R.No. Analytical Reference Number

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

 

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