SOP on Operating procedure for tap density apparatus make : electrolab

  • OBJECTIVE
  • To lay down the procedure for Operation of Tap density apparatus, Make Electro lab.
  • SCOPE
  • This SOP shall provide the Operating procedure of Tap density apparatus of quality control department.
  • RESPONSIBILITY
  • Officer/ Executive – Quality Control
  • ACCOUNTABILITY
  • Head QC/QA
  • PROCEDURE
  • Before starting the operation Check for the area cleanliness and instrument cleanliness.
  • Connect the pin to power supply.
  • Switch on the power.
  • The instrument displays Main Menu.
  • Choose the mode menu either ‘USP or User’ by pressing Digit scroll key.
  • Press the method key to set USP 1 or USP II.
  • CONDITION I (If as per USP 1):
  • Stroke Height :   14mm ± 2 mm.
  • Strokes / Min :  Nominal 300 times.
  • Tap count 1 :  500 times.
  • Tap count 2  :  750 times.
  • Tap count 3  :  1250 times.
  • Press set key, to set tap count 1 to 500 by using ⇑⇓⇐ key
  • Press enter key, set tap count 2 to 750 by using ⇑⇓⇐ key
  • Press enter key, set tap count 3 to 1250 by using ⇑⇓⇐ key
  • Press enter key, set clock timely using ⇑⇓⇐ key
  • Press enter key, set date by using shift key and ⇑⇓ key
  • Press enter key, it will ask for “Print last result “if you need shift cursor to Y other wise to N. Press enter key.
  • Press reset key, Now your method get saved as per USP 1.
  • Press start key, input weight of sample by using shift key and⇑⇓ key in grams.
  • Press enter key, input initial volume (Vo) by using shift key and⇑⇓ key key in ml.
  • Keep the cylinder in Holder and press start key; it will give a taps box 500 times.
  • Measured tapped volume (Va) and input by using shift key and ⇑⇓ key
  • Press enter key and press start key. It will give a taps force 750 times.
  • Measured tapped volume (Vb) input by using shift key and ⇑⇓ key
  • Note: If the difference volume of 1st tap and 2nd tap i.e. Va – Vb is more than 2% then proceed for tap count 3 i.e. 1250 times by same manner.  Measure the final volume (Vf) if so not the stop the experiment in Tap count 2 only.
  • Give the connection to printer and go to printing mode by using SET and Enter Key.
  • Set printing mode to Y, automatically printing will come. We can get tap density Initial Density, compressibility Index and Hausner Ratio.
  • CONDITION II (if as per USP II):
  • Stroke height : 3mm+/-10 %.
  • Strokes/min : about 250 times.
  • Tap count 1 : 500 times.
  • Tap count 2 : 750 times.
  • Tap count 3 : 1250 times.
  • Proceed same as condition 1 for step 5.8 – 5.22.
  • CONDITION III (if as per user mode):
  • The mode to user mode by using set keys and shift key.
  • Press set key, set taps count as per the product specification.
  • Press  start key to start the tapping.
  • Measured the volume and calculate manually.
  • Calculate the bulk density of the blend according to the formula given below.
  • Bulk density g/cc = Wt. of the sample : Volume of the cylinder
  • If in between tapping need stop use (STOP KEY).
  • Press reset key.
  • Enter the details in the instrument log book.
  • Switch off the instrument.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    DateRevision NumberReason for Revision
    00New SOP

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