To lay down a procedure for Operation & Calibration of Disintegration test apparatus.
This procedure is applicable for procedure for Operation & Calibration of Disintegration test apparatus.
QC Officer/ QC Executive
- Do not switch on the mains if water in the tank is not up to the mark.
- While placing and removing the basket assembly do not apply excessive force.
- Do not use abrasive materials to clean the instrument.
- Do not bend the heater while clean the water bath.
- Operating Procedure
- Ensure that instrument is clean and free from dust.
- Ensure that clean purified water / DM Water is filled in the basket till the desired level.
- Switch ON the main supply and the instrument ON/OFF switch on the instrument.
- Switch on the heater by pressing “TEMP” Key.
- Set the temp. by aero key at 370C.
- Set the time by aero key the desired test t0.
- Place the capsules to be tested in each of the six cylinders of basket rack assembly after achieved the desired test temperature.
- Place the disks if mention in the monograph.
- Press the on key the instrument.
- Watch the complete disintegration of the capsules and note down in usage log book of disintegration test apparatus.
- Press stop key to stop the test.
- Switch on the mains and switch on the instrument.
- Ensure that the beakers are filled with water the DM water.
- Press the Temp. key for set the temperature at 370C and press enter key.
- Allow the temperature to reach to 370C.When the display shows the temperature 370C, insert the calibrated thermometer into the beaker.
- Note down the reading in calibration record of disintegration test apparatus instrument operate for 2 hours (120 min) and check the temperature after 10 minute with calibrated thermometer and note down the reading.
- Repeat the two more time to confirm the result.
- Results are found satisfactory if the temperature lies between 370C ± 20C.
- For Cycles per minute: Note down the number of cycles in one minute; note down the reading after 10 minutes for 2 hour (120 minute).
- Repeat the test two more times to confirm the results.
- Result are found satisfactory if the cycles per minute 29 to 32.
- For Distance Travelling: Measure the distance travel of basket by calibrated scale.
- Result are found satisfactory if the distance travelling is between 53 mm to 57 mm.
- Frequency – one in month.
Trainer : Manager – Quality Control
Trainees : Staff of the QC departments
Master Copy : QA Department
Controlled Copy : QC Department
Display Copy : QC Department
|Sr. No.||Title||Annexure No.|
|SOP||Standard Operating Procedure|