Calibration procedure for tap density apparatus [Make- electro Lab]. Quality assurance

• OBJECTIVE
• To lay down the procedure for Calibration of Tap density apparatus, Make – Electro lab.
• SCOPE
• This SOP shall provide the Calibration 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 and switch on the power.
• Operate the instrument as per sop no BA (II) QA210, operation of Tap density apparatus.
• The instrument shall be calibrated for the following parameters.
• (a) The drop height of the cylinder holder.
• (b) The number of drops per Minute of cylinder holder.

• Calibration of Drop height of cylinder holder for USP method 1:
  
  • Open the top cover by removing bottom screws.
  • Turn the cam attached to the motor shaft clock wise, so that the cylinder holder shaft is at the minimum position.
  • Make sure that the bottom plate of the cylinder holder is in perfect contact with the tapping platform.
  • Measure the distance between the platform and the clamp plate of cylinder holder; this reading is the base height (Hr).
  • Rotate the cam further by hand, clockwise till the cylinder holder shaft reaches maximum height.
  • At this position the shaft tip should be on the falling edge of the cam arm. Mark this arm no -1.
  • With a digital Vernier caliper measure the distance between the top plate of frame and clamp plate of cylinder holder.
    This is height H1.
  • Make a mark on the point of measurement on the top plate of frame and on the cylinder plate.
  • The difference between these two readings is drop height of the cylinder.
  • Mark arms 1, 2 and 3 and heights H1, H2, H3 and so on. Repeat the above procedure for all arms.
  • Make sure that the point of measurement on the platform and on the cylinder holder plate is maintained the same for all measurements.
  • Record the results in the given format (Annexure 1).
  • Calibration of Drop height of cylinder for USP 2 method.
  • Repeat the above all steps for all arms and record the results in the given format.
• Calibration for Number of drops of cylinder holder per minute:
  
  • Set the instrument as per USP 1 method and operate the instrument.
  • Paste a small piece of Metal reflection paper on cam.
  • Focus the light of tachometer on metal reflection paper sharply at a distance about 20cm approximately.
  • Multiply the rotation per minute which is displaying in tachometer by three and record the values in calibration format.
  • Repeat the operation for 3 times and check the set number of tapings and record the values in calibration format.
  • The number of drops should be between 300 ± 6 drops.
  • Similarly set the instrument as per USP 2 method and operate the instrument.
  • Multiply the rotation per minute, which is displaying in tachometer by four and record the values in calibration format.
  • The number of drops should be 250 ± 5 drops.
  • Enter the details of calibration in log book.

• Forms and Records (Annexures)
• Instrument calibration Format Bulk Density Test Apparatus – Annexure-1
• Distribution
• Master copy –  Quality Assurance
• Controlled copies- Quality Assurance, Production, Quality Control.engineering
• History
  

  Date	Revision Number	Reason for Revision
  –	00	New SOP

   Annexure-1

   Instrument calibration Format Bulk Density Test Apparatus

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