Disintegration test apparatus operation and calibration

1.0 OBJECTIVE :

To lay down the procedure for operation and calibration of disintegration test apparatus.

2.0 SCOPE :

This SOP is applicable for operation and calibration of disintegration test apparatus (Electrolab make), which will be used for finding disintegration time of capsules or tablets in quality control department.

3.0 RESPONSIBILITY :

Quality control Chemist and above

4.0 ACCOUNTABILITY:

Quality Control Head

5.0 PROCEDURE :

5.1 Procedure for Operation of Disintegration test apparatus :

Ensure that the instrument is clean and free from dust.

Ensure that all the switches and knobs are off and in normal condition.

Switch on the main switch put ON/OFF. switch to ON position and display of instrument ON.

Fill the tank with water up to marked level.

Connect the external probe A & B to socket provided on rear side of the instrument.

Place the two jars A & B filled the liquid medium specified as per monograph.

Fix the external probe of respective jar to the beaker using clip. Insert the probe into the beaker and ensure probe is straight and not touching the glass beaker and the basket.

Then select the designed mode and set the time using Time key.

Then set the temperature using Temp. key at 37°C ± 2°, note down the temperature using thermometer of the medium before starting the operation.

Then press the OPTN key select time using F1 key. Register the value on display.

Using OPTN key set the current date & time and programmed details.

Finally after setting the instrument now add the number of samples (tablets & capsules) as specified in the monograph, in the cylindrical holes which is provided on the basket assembly A & B.

Add the discs where applicable and specified in the monograph.

Then start the oscillation by using RUN/HALT key OR. Switch off the instrument and clean the whole assembly.

After completion of the analysis, the results are entered in raw data by that particular analyst.

The respective data is reviewed by lab location head or his/her designee of that particular lab location.

Water bath water should be replaced an every week up to the marked level.

5.2 Cleaning :

Clean the apparatus whenever used as per below

Remove the external probe A & B from socket provide on rear side of instrument.

Remove the disc from the glass tube basket assembly.

Clean the disc with purified water and dry with lint free cloth.

Clean the glass tube basket assembly with purified water.

Clean the apparatus externally with dry lint free cloth.

5.3 Calibration of Disintegration test apparatus :

Calibration procedure for Thermostat :

Switch ON The mains and Switch ON the instruments ON /OFF Switch of rear side of instrument.

Ensure that the beakers are filled with the purified Water.

Press set and Temp. Key and set the temperature at 37ºC. Press enter Key.

When the display shows 37ºC temperature, insert one calibrated thermometer into the beaker.

Record the reading in calibration format after interval as per calibration format, repeat the same process for remaining side jar and record the observation in calibration format.

Acceptance criteria: temperature through out the operation should be within 37ºC ± 2ºC.

Calibration For Cycle/Oscillation Per Minute :

Switch ON the mains and the instrument.

Press Start key once to start the test.

Note the number of cycle /oscillation in one minute. Repeat the test after the interval for five min. and record the number of cycle /Oscillation as per the calibration format, repeat the same procedure for remaining side jar and record the observation in calibration format.

Acceptance criteria: Results are found satisfactory if number of cycle/Oscillation per minute are in between 28 to 32.

Calibration For Distance Traveled :

Switch ON the mains and instrument.

Press start key once to start the test.

Note the traveling distance of the basket rack assembly on the device from a calibrated scale. Repeat the test two more times to confirm the results.

Acceptance criteria: Distance traveled should be within 50 mm to 60 mm.

6.0 ABBREVIATIONS:

Abbreviation Expanded form

SOP Standard Operating Procedure

QA Quality Assurance

NO. Number

DT Disintegration test