Operation and Calibration of Disintegration Test Apparatus SOP

By / Quality control / QC, SOP /

SOP of Disintegration Test Apparatus-

SOP covers below points:

  • Operation of Disintegration Test Apparatus
  • Calibration of Disintegration Test Apparatus.
  • Calibration Parameters of Disintegration Test Apparatus
    • Number of cycles per minutes
    • Temperature verification
    • Distance measuring between up/down cycles

For General information on Disintegration Test click below link:

Disintegration Test
1.0 OBJECTIVE :
  • To provide a procedure for Operation and Calibration of Disintegration Test Apparatus.
2.0 SCOPE :
  • This procedure is applicable to DBK instrument make Disintegration Test Apparatus.
3.0 RESPONSIBILITY :
  • Quality control Chemist and above
4.0 ACCOUNTABILITY:
  • Quality Control Head
5.0 PROCEDURE :

5.1 OPERATION

  • Connect the Disintegration Test Apparatus to main power supply.
  • Switch on the MAINS.
  • Green coloured LED and display will glow.
  • Keep 1 litre glass beaker on the hot plate of apparatus.
  • Fill the medium (generally distilled or purified water if not specified in monograph) in the beaker such that at the highest point of upward stroke the wire mesh of the basket remains at least 15 mm below the surface of the medium and during the downward stroke lower point is at least 25mm above the bottom of the beaker.
  • Maintain appropriate temperature (as per monograph) with HEAT control knob.
  • Bring the temperature of the media at 37°C (±2°C ), or as specified in monograph.
  • Place the tablet or capsules in each of six tubes of basket assembly.
  • Add disc to each tube, if directed in the appropriate general monograph.
  • To set the required Time press ’SET’ switch.
  • Orange coloured LED will glow.
  • Adjust the set time by ‘UP’ and ‘DOWN’ switches.
  • Press START switch.
  • Indication will switch over from ‘Set Time’ to ‘Actual Time’.
  • Start LED will glow & timer will start counting the Time.
  • Lift the basket from the medium and observe the tablets.     
  • The tablets or capsules pass the test if all of them have disintegrated.
  • If 1 or 2 tablets or capsules fail to disintegrate, repeat the test on 12 additional  tablet or capsules not less than 16 of the total of 18 tablets or capsules tested disintegrate.
  • If the tablet or capsules adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc.
  • The preparation complies with the test if all the  tablet or capsules in the repeat test disintegrate.

5.2 CALIBRATION

  • NUMBER OF CYCLES PER MINUTES
    • Operate the apparatus as per this SOP.
    • Record the frequency of moving UP and DOWN of the basket assembly at a time, as per Annexure No. 01.
    • Record the frequency (twice) of moving UP and DOWN of basket assembly manually with respect to time in Calibration format.
    • Do not stop instrument in between the operation.
    • Acceptance criteria : The number of cycle per minute is within 28 to 32 throughout the period of operation.
  • TEMPERATURE VERIFICATION
    • Fill the beaker with distilled water.
    • Attach basket assembly and start the instrument.
    • Insert the calibrated thermometer in one of the tube of basket assembly.
    • Wait till temperature reaches between 35°C to 39°C.
    • Start recording the reading.
    • Record temperature reading after 05 minutes interval up to 60 minutes from the start.
    • Perform the test for both the basket assembly position individually.
    • While performing the test, do not keep thermometer inside the basket assembly constantly.
    • Insert the thermometer between 2 to 3 minutes prior to the measurement of temperature to give stable reading.
    • Acceptance criteria : The temperature remain 37+2°C throughout the operation.
  • DISTANCE MEASURING BETWEEN UP/DOWN CYCLES
    • Attached the basket assembly A (Side A-Left hand side of the operator)
    • Put the calibrated scale against the basket assembly in vertical position.
    • Start the apparatus and note the value in mm from the scale up and down positions.
    • Repeat above steps with basket assembly B (Side B-Right hand side of the operator)
    • Acceptance criteria : Distance of the up/down cycles shall be between 53 to 57 mm.
  • FREQUENCY : Quarterly
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
mlMilliliter
0CDegree Celsius
LEDLight Emitting Diode
mmMillimeter

7.0 ANNEXURES:
  Annex. No.Title
01Calibration of Disintegration Test Apparatus

8.0 SOP REFERENCES
  • Manual of Disintegration Test Apparatus
  • Indian Pharmacopoeia

END OF THE SOP

ANNEXURES :

Annex. No. 01 Calibration of Disintegration Test Apparatus

Page No. 01

Page No. 02