SOP For Operation and Calibration of Bulk Density Apparatus

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  1. OBJECTIVE:

The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling, Operation, and Calibration of Bulk Density Apparatus.

  1. SCOPE:

This SOP is applicable to Bulk Density Apparatus in Quality Control Department at manufacturing facility of XXX.    

  1. RESPONSIBILITY: 
  1. Analyst / Section Head or his designee shall be responsible to follow the SOP.
    1. The Head of Quality Control Department or his designee shall be responsible for implementation of the SOP.
  1. PROCEDURE:
  1. PRELIMINARY CHECK :
  1. Check that the instrument is clean and free from dust, if not, then clean with a soft cloth duster.

4.2  BASIC OPERATION:

  1. Connect the plug to the main power supply.
  2. Switch on the instrument by the ON/OFF key.
  3. Ensure that the instrument is calibrated before use. Put the main switch “ON” which is on backside of the instrument
  4. Digital menu shall appear on screen showing 

LABINDIA TD 1025

TAP DENSITY TESTER.

  1. Press Enter

Screen shows

1) Prog  2) Run  3) Prnt

4) Disp  5) Funct  6) cfg.

  1. Then press 1) prog

Display shows 1) Add / Edit 2) view 3) copy 4) Delete

  1. Then press 1) Add/Edit for new programming 
Prog. No. (1-20): Add/Edit mode  

Display show 

  1. Press (1) or as which is required. Give sample name: Press enter.
  2. Display show Test method. 

USP 2) ASTM & Enter 

  1. Press 1 for USP method
  2. Display Show.

USP method 1) USP-I 2) USP-II 3) USP-III press 2 or as per suitable & enter Display shows cylinder vol (ml): (100/250) Enter 100 or 250 as required. 

  1. Display shows mode: 1) USP 2) USER press 2 & enter Display shows tap count : enter (10-9999)
  2. As required & enter then tap count 2: (10-9999)
  3. Enter value as required.
  4. Then display shows. Tap count 3: Enter value (10-9999) as required Then press BACK until display shows.

1) Prog 2) Run 3)Print 4) Disp 5) Funct 6) cfg

  1. Then press 2) Run & Enter
  2. Display shows 1) Run 2) View 
  3. Then press 2) view for viewing the programme & press 1) Run for continue 
  4. The display shows. Prog. No. (1-20): Enter number which is required & enter display shows Identification No.: put that no. & enter. Display shows. 
  5. Sample wt (9):(0.0001-999.99) : Enter the weight of sample Volume. 
  6. Enter volume of sample in mesuring cylinder & enter to continue for tap count 2 & 3& press finished & enter escape.    
  7. Enter the volume after tapping and calculate the tapped bulk density in gm/cc or gm/ml.
  8. Switch off the mains.
  9. Dispose the Powder/Sample by making a slurry in water, after the test is over.
  10. Fill the instrument usage log whenever the instrument is used. 

4.3      CALIBRATION

            Calibration frequency:   Quarterly

4.3.1 Set the number of Taps to 25, 50,100. Count the no. of tapping that appear on the display. The number obtained should match with the no. of taps. 

  1. TRAINING: 

Trainer : Head – Quality Control 

Trainees : Sectional Heads / Analyst / Officers

  1. DISTRIBUTION: 

Controlled Copy No.1 :  Head of Department – Quality Assurance

Controlled Copy No.2 :  Head of Department – Quality Control

Reference Copy No.1 :  Head of Department – Quality Control

Original Copy :  Head – Quality Assurance 

  1. ANNEXURE: 

Annexure I : Calibration Test Data Sheet

  1. REFERENCES: 

Instrument / Equipment User Manual

  1. REVISION HISTORY: 

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