Instrument Calibration Protocol for Disintegration Test Apparatus

Instrument Calibration Protocol for Disintegration Test Apparatus
Instrument Calibration Protocol for Disintegration Test Apparatus

Instrument Calibration Protocol for Disintegration Test Apparatus

Instrument:Disintegration Test Apparatus
Instrument ID. Number     : 
Reference SOP No.             : 
Model No.                           :ED-2L/ Any other ________
Date of Calibration              : 
Make:Electro lab/ Any other _________
Next due date: 

Calibration procedure for 6 rack assembly:

1. Calibration of Temperature :

Check the thermostatic arrangement for heating the liquid that maintains the temperature between 37.0 ± 1.0°C with the help of Calibrated Thermometer.

Calibrated Thermometer ID:

Set TemperatureStandard Thermometer  ReadingDifferenceLimitsRemarks
37.0 °C    ± 1.0 °C   

2. Frequency of Raising and Lowering of Rigid Rack Assembly :

  Measure the frequency of rising and lowering of the rigid rack assembly. Record the observations:

Frequency of raising and lowering of rigid rack assemblyLimitsRemarks
   29 – 32 Cycles / minutes 

3. Calibration of Display Time: Set the time 10 minutes and start the instrument.

After 10 minutes, check the difference between display time and time in stopwatch.

Calibrated Stop watch ID:

Set TimeObserved Time on StopwatchDifferenceLimitsRemarks
10 minutes  ± 5 Seconds 

4. Stroke Length:

Measure the distance travelled by the upper plate when the arm of the basket – rack assembly moves from its top most position to lowest position (downward stroke) or the distance travelled by the upper plate when the arm of the basket – rack assembly moves from its lowest most position back to its top position (upward stroke) using a calibrated scale.

Sr. No.Stroke Length 55 ± 2mm Basket AStroke Length 55 ± 2mm Basket B
   

5. Basket Rack Assembly and Disk Parameters Check Record:

Code No. of Vernier Caliper: _____________

Date of Calibration: _____________ 

Next Calibration Due: _____________________

ParametersLimitsObserved Value
Transparent Tube Length7.5 – 8.0 cm 
Transparent Tube Inside Diameter20.7 – 23.0 mm 
Transparent Tube Wall Thickness1.0 – 2.8 mm 
Plastic Plate Diameter8.8 – 9.2 cm 
Plastic Plate Thickness5.0 – 8.5 mm 
Plastic Plate Hole Diameter22 – 26 mm 
Mesh Size1.8 – 2.2 mm 
Wire Diameter0.57 – 0.66 mm 
ParametersLimitsObserved Value
ShapeCylindrical 
Thickness9.35 – 9.65 mm 
Diameter20.55 – 20.85 mm 
Hole of the disc1.9 – 2.1 mm 

Calibration procedure for 3 rack assembly:

6. Calibration of Temperature :

Check the thermostatic arrangement for heating the liquid that maintains the temperature between 37.0 ± 1.0°C with the help of Calibrated Thermometer.

Calibrated Thermometer ID:

Set TemperatureStandard Thermometer ReadingDifferenceLimitsRemarks
37.0 °C  ± 1.0 °C 

7. Frequency of Raising and Lowering of Rigid Rack Assembly :

  Measure the frequency of rising and lowering of the rigid rack assembly. Record the observations:

Frequency of raising and lowering of rigid rack assemblyLimitsRemarks
 – 32 Cycles / minutes 

8. Calibration of Display Time: Set the time 10 minutes and start the instrument.

After 10 minutes, check the difference between display time and time in stopwatch.

Calibrated Stop watch ID:

Set TimeObserved Time on StopwatchDifferenceLimitsRemarks
10 minutes  ± 5 Seconds 

9. Stroke Length:

Measure the distance travelled by the upper plate when the arm of the basket – rack assembly moves from its top most position to lowest position (downward stroke) or the distance travelled by the upper plate when the arm of the basket – rack assembly moves from its lowest most position back to its top position (upward stroke) using a calibrated scale.

Sr. No.Stroke Length 55 ± 2mm Basket AStroke Length 55 ± 2mm Basket B
   

10. Basket Rack Assembly and Disk Parameters Check Record:

Code No. of Vernier Caliper: _____________

Date of Calibration: _____________ 

Next Calibration Due: _____________________

Basket Rack Assembly Parameters:

ParametersLimitsObserved Value
Transparent Tube Length7.5 – 8.0 cm 
Transparent Tube Inside Diameter20.7 – 23.0 mm 
Transparent Tube Wall Thickness2.0 – 3.0 mm 
Plastic Plate Diameter9.5 – 9.9 cm 
Plastic Plate Thickness7.5  – 10.5 mm 
Plastic Plate Hole Diameter36.0 – 40.6mm 

Disk Parameters:

ParametersLimitsObserved Value
ShapeCylindrical 
Thickness15.15 – 15.45 mm 
Diameter31.27 – 31.53 mm 
Hole of the disc3.05 – 3.25 mm 

Calibrated By 

Signature/

Date

Checked By   

Signature/

Date

Approved By

Signature/

Date

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