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 Temperature | Standard Thermometer Reading | Difference | Limits | Remarks |
| 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 assembly | Limits | Remarks |
| 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 Time | Observed Time on Stopwatch | Difference | Limits | Remarks |
| 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 A | Stroke 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: _____________________
| Parameters | Limits | Observed Value |
| Transparent Tube Length | 7.5 – 8.0 cm | |
| Transparent Tube Inside Diameter | 20.7 – 23.0 mm | |
| Transparent Tube Wall Thickness | 1.0 – 2.8 mm | |
| Plastic Plate Diameter | 8.8 – 9.2 cm | |
| Plastic Plate Thickness | 5.0 – 8.5 mm | |
| Plastic Plate Hole Diameter | 22 – 26 mm | |
| Mesh Size | 1.8 – 2.2 mm | |
| Wire Diameter | 0.57 – 0.66 mm |
| Parameters | Limits | Observed Value |
| Shape | Cylindrical | |
| Thickness | 9.35 – 9.65 mm | |
| Diameter | 20.55 – 20.85 mm | |
| Hole of the disc | 1.9 – 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 Temperature | Standard Thermometer Reading | Difference | Limits | Remarks |
| 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 assembly | Limits | Remarks |
| – 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 Time | Observed Time on Stopwatch | Difference | Limits | Remarks |
| 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 A | Stroke 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:
| Parameters | Limits | Observed Value |
| Transparent Tube Length | 7.5 – 8.0 cm | |
| Transparent Tube Inside Diameter | 20.7 – 23.0 mm | |
| Transparent Tube Wall Thickness | 2.0 – 3.0 mm | |
| Plastic Plate Diameter | 9.5 – 9.9 cm | |
| Plastic Plate Thickness | 7.5 – 10.5 mm | |
| Plastic Plate Hole Diameter | 36.0 – 40.6mm |
Disk Parameters:
| Parameters | Limits | Observed Value |
| Shape | Cylindrical | |
| Thickness | 15.15 – 15.45 mm | |
| Diameter | 31.27 – 31.53 mm | |
| Hole of the disc | 3.05 – 3.25 mm |
Calibrated By
Signature/
Date
Checked By
Signature/
Date
Approved By
Signature/
Date