SOP For calibration of disintegration test apparatus
OBJECTIVE
To lay down a procedure for Calibration of Disintegration test apparatus.
SCOPE
This Standard Operating Procedure (SOP) is applicable to DT apparatus .
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 as per SOP.
The following parameters shall be verified under the calibration of D T Apparatus.
Number of cycles per minute.
Temperature.
Timer
Stroke length of basket assembly.
Aperture of wire mesh & Diameter of wire mesh.
NUMBER OF CYCLES PER MINUTE
Adjust if necessary the volume of the water in the beakers such that the wire mesh at the highest point is at least
25 mm below the surface of water and at its lowest point is at least 25mm above the bottom of beaker.
Count the cycles of up & down of the basket assembly per minute using a calibrated stop watch.
Repeat the same procedure thrice. Record the number of cycles
Acceptance criteria – Cycles per minutes should be 29 to 32.
TEMPERATURE CALIBRATION
Set the temperature at 37 °C.
Check the temperature of water in the beaker and wait till display shows temperature with in 37°c ± 0.5°c.
Measure the temperature of water in the beaker using calibrated thermometer and record the reading of both thermometer value and instrument-displayed value in annexure – 1
Acceptance criteria – Instrument displayed value and calibrated thermometer value should match by ± 0.5°C and temperature value should be with in 37 ±0.5°C.
TIMER CALIBRATION
Check the instrument timer for accuracy at 15,30 and 60 minutes respectively against a calibrated Stop watch.
Enter observation in the format
Acceptance criteria – time variation should not be more than ± 20 seconds between the Instrument timer and calibrated
timer
WIRE MESH CALIBRATION
Use calibrated Vernier caliper for measuring the aperture size.
Check & ensure that there is no loose end in any of the tube.
Check randomly at least one aperture from each tube and record the observation.
Check the diameter of wire selected at least one number from all the tubes and record the observation.
STROKE LENGTH OF BASKET ASSEMBLY
Unscrew the basket A from the bottom
Remove the basket bottom plate and cover.
Remove one tube and replace the bottom cover and screw it again.
Engage the basket to the basket holder.
Insert the measuring scale or Vernier into the disc from where the tubing is removed.
Note: the scale bottom should touch the bottom of the beaker.
Start the instrument and press RUN / HALT key of basket A from front panel
Measure the lower most position from bottom of beaker and top most position of basket holder.
Record the distance in mm.
Repeat the steps 5.9.1to 5.9.8 with Basket assembly B.
Acceptance criteria – stroke length should be 55 ± 2 mm.
Fill the details of the calibration status in the label pasted on the Instrument.
Report any discrepancy observed during calibration to Manager QA/QC 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 |
| 1 | No. of Cycles/min. | Visually/Calibrated stopwatch | 29-32 Cycles/min |
| 2 | Temperature | Calibrated Thermometer | 37± 0.5°C |
| 3 | Time | Calibrated Stopwatch | ±20 sec / 10min |
| 4 | The aperture of wire mesh | Calibrated Vernier caliper | 1.80 to 2.20 mm |
| 5 | Diameter of wire mesh | Calibrated Vernier caliper | 0.60 – 0.65 mm |
| 6 | Stroke length of the basket assembly | Calibrated Vernier caliper/ scale [6 inches] | 55 ± 2 mm |
Forms and Records (Annexures)
Instrument Calibration Format: Disintegration Test Apparatus – Annexure-1
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure-1
Instrument Calibration Format: Disintegration Test Apparatus
- Location
- Instrument ID
- Make
- ELECTROLAB
- Model
- SOP No.
- Next Calibration Due On
Cycles/Minute (Up and down strokes)
| S.No. | Minutes | No. of Cycles/minutes | Limit |
| 1. | 1.00 | 29-32 Cycles / Minute | |
| 2. | 1.00 | ||
| 3. | 1.00 |
Temperature calibration
| SNo | Set Temperature | Beakers I | Beakers II | Limit | ||
| Thermometer | Instrument | Thermometer | Instrument | 37± 0.5 °C | ||
| 1. | 37 °C | |||||
Timer Calibration
| S.No. | Set time in minutes | Observed Time | Limit | Remarks | ||||||
| By stopwatch | By instrument | |||||||||
| 1 | 15 | ± 20 sec at any set time | ||||||||
| 2 | 30 | |||||||||
| 3 | 60 | |||||||||
| Stroke length | ||||||||||
| S.No | Stroke Length | Limit | Remarks | |||||||
| I | II | |||||||||
| 55± 2 °C | ||||||||||
| Mesh Size | ||||||||||
| Tube No. | Mesh Size in mm Observed Value | Limit | Remarks | |||||||
| L1 | 1.80 to 2.20 mm | |||||||||
| L2 | ||||||||||
| L3 | ||||||||||
| L4 | ||||||||||
| L5 | ||||||||||
| L6 | ||||||||||
| R1 | ||||||||||
| R2 | ||||||||||
| R3 | ||||||||||
| R4 | ||||||||||
| R5 | ||||||||||
| R6 | ||||||||||
| Wire Diameter | ||||||||||
| Tube No. | Mesh Size in mm Observed Value | Limit | Remarks | |||||||
| L1 | 0.60 to 0.65 mm | |||||||||
| L2 | ||||||||||
| L3 | ||||||||||
| L4 | ||||||||||
| L5 | ||||||||||
| L6 | ||||||||||
| R1 | ||||||||||
| R2 | ||||||||||
| R3 | ||||||||||
| R4 | ||||||||||
| R5 | ||||||||||
| R6 | ||||||||||
*L 1- 6 = left basket tubes, R 1- 6 = right basket tubes