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Calibration procedure for disintegration test apparatus (ED-2AL). Quality assurance

  • OBJECTIVE
  • To lay down a procedure for Calibration of Disintegration test apparatus
  • SCOPE
  • This Standard Operating Procedure (SOP) is applicable to DT apparatus placed in IPQC lab and in Quality Control.
  • RESPONSIBILITY
  • IPQA / Production Executive / Officer 
  • ACCOUNTABILITY
  • Head–Quality Assurance
  • PROCEDURE
  • Check the water level in the water bath.
  • Fill the water in the beakers up to required mark.
  • Operate the DT (Disintegration Test) machine
  • Adjust if necessary the volume of the water in the beakers such that the wire mesh at the highest point is at least 25mm below the surface of water and at its lowest point is at least 25mm above the bottom of water.
  • Count the cycles of up & down of the basket assembly per minute using a calibrated stop watch.
  • Repeat the same procedure thrice
  • Cycles per minutes should be 28 to 32.
  • Set the temperature at 37 °C.
  • Check the temperature of water in the beaker and wait till temperature is 37°c  ± 2°c.
  • Measure the temperature of water in the beaker using calibrated thermometer, after every 30 minutes up to 120 minutes.
  • Set the timer at 10,30,45 and 60 minutes respectively
  • Check the time after every timer using calibrated stopwatch
  • FOR WIRE MESH CALIBRATION
  • Use calibrated Vernier caliper for measuring the aperture size.
  • Check randomly at least one aperture from each tube and note down the observation in calibration format.
  • Check the diameter of wire selected at least one number from all the tubes.
  • Check  & observed that there is no loose end in any of the tube.
  • Fill the details of the calibration status in the label pasted on the Instrument / Apparatus.
  • Report  any  discrepancy  observed during calibration to Quality  Assurance Manager  and  notify the  defect  to  engineering  department  or  Service  Engineer of  the  instrument. Affix an Under Maintenance label on the   instrument.
  • Frequency of calibration
  • Calibrate the apparatus quarterly and after each maintenance job.
S.NO. PARAMETER STANDARD ACCEPTANCE CRITERIA FREQUENCY REFERENCE
 

1

 

No.  of  Cycles/min.

 

 

Visually/Calibrated stop watch

28-32 Cycles/min  

Quarterly

IP/ OSp
2 Temperature Calibrated Thermometer 37±2°C
3 Time Calibrated Stopwatch ±20 sec / 10min
4 Aperture of wire mesh Calibrated Vernier caliper 1.80 to 2.20 mm
5 Diameter of wire of wire mesh Calibrated Vernier caliper 600- 655 µm
  • 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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