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SOP on Operating procedure for friability test appratus

  • OBJECTIVE
  • To lay down a procedure for Operation of Friability Test Apparatus (Make – Electrolab Model-EF2)
  • SCOPE
  • This Standard Operating Procedure (SOP) is applicable to check the friability of In-process samples/QC samples.
  • RESPONSIBILITY
  • IPQA / QC/Production Executive / Officer
  • ACCOUNTABILITY
  • Head –Quality Assurance
  • PROCEDURE
  • Clean the apparatus free of dust with dry cloth from out side everyday.
  • Clean the rotating disc with dry cloth at the start and end of every shift .Wet cloth may be used occasionally if cleaning is not proper with dry cloth but this should follow drying of inner surface by first wiping with dry cloth and exposure to atmospheric air.
  • Switch ON the instrument.
  • At the power ON, drums will initialize itself to the loading position.
  • The display will now show ‘Start’.
  • For tablets weighing upto 0.65 g each, take sample equivalent to 6.5g; for tablets weighing more than 0.65g take 10 tablets.
  • Place the tablets on a sieve no. 1000 and remove any loose dust with aid of air or soft brush.
  • Accurately weigh the tablets (Wi) and slide the tablets gently into the drum from the side slit provided on the drum.
  • Select the ‘Time mode’ or ‘Revolution mode’ as desired by pressing the <Time> or <Count> key respectively.
  • The Mode indicator LED will indicate the selected mode.
  • The display will show the previous time or count values.
  • Enter the desired value for the selected mode and press the <Enter> key to register the value.
  • Press <Run/Halt> key to start the test.
  • The drum of Friability test apparatus will start rotating.
  • The display will show elapsed time or cont as per mode selected.
  • When the test is over, the drum rotates in reverse direction, discharging the tablets in to the tray.
  • The test over is indicated by an audible beep and the display would show “End”.
  • Remove the loose dust from the tablets as in 4.7
  • If no tablet is cracked, split or broken, weigh the tablets again(Wf).
  • Calculate the % friability as per formula given below:
  •  %   Friability =  (Wi  – Wf)  : Wix 100
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

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