CALIBRATION OF TAP DENSITY APPARATUS

• OBJECTIVE:

• To lay down the procedure for Calibration of Tap density apparatus.

• SCOPE:

• This SOP is applicable to the procedure for Calibration of Tap density apparatus at {Company Name} {Location}.

• RESPONSIBILITY:
• Executive/Designee Quality Control is responsible to calibrate the instrument as per SOP.
• Head QC: Ensure the compliance of SOP.
• ACCOUNTABILITY:

             QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
  • Before switching on the instrument, check the area and instrument cleanliness.
  • Connect the plug to the power supply and switch on the power.
  • Operate the instrument as per SOP.
  • The following parameters to be calibrated for Tap density apparatus:
• Drop height of cylinder holder by using digital vernier caliper
• Number of drops per minute by using stopwatch
  • 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 top plate of frame and the clamp plate of cylinder holder by using digital vernier caliper; this reading is the base height (H_R) as shown in figure (a).
    • 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 as shown in figure (b).
    • Measure the distance between the top plate of frame and clamp plate of cylinder holder by using digital vernier caliper. This is height H_I.

• 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 with both cylinder holders.
  • Make sure that the point of measurement on the top plate of frame and on the cylinder holder plate is maintained the same for all measurements.
  • Record the results in the calibration format as per Format-I.

• Repeat the same procedure for all arms with both cylinder holder (figure c) and record the results in the calibration format.
  • Calibration for Number of drops of cylinder holder per minute:
    • Choose the mode menu to ‘USP1’ by using digital scroll key.
    • Press set key, set taps count to 300.
    • Press start key to start the tapping and start the stop watch.
    • Stop the stop watch after 1 Minute and note down the number of drops.
    • The number of taps should be 300 ± 6.
    • Similarly choose the mode menu to ‘USP11’ by using digital scroll key.
    • Press set key, set taps count to 250.
    • Press start key to start the tapping and start the stop watch.
    • Stop the stop watch after 1 Minute and note down the number of drops.
    • The number of drops should be 250 ± 5.
• REFERENCES:

Not Applicable

• ANNEXURES: 

        ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:
• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Quality Control
• Master Copy                    :          Quality Assurance Department
• ABBREVIATIONS:

• REVISION HISTORY:             

CHANGE HISTORY LOG

Annexure-I
TAP DENSITY APPARATUS CALIBRATION RECORD