Tablet disintegration testing is used as a quality-assurance measure. It is not a true predicter of how well the dosage form will release its active ingredient in vivo. The United States Pharmacopea (USP) sets standards for tablet disintegration testing. The apparatus is relatively simple. It consists of a basket rack holding six plastic tubes open at the top and bottom. The bottom is covered with a 10 mesh screen. The rack is immersed in a suitable liquid at 37 degrees C. It moves up and down at a specifie
SOP FOR OPERATION1.0. PURPOSE:
To provide a procedure for operation of Disintegration tester.2.0. SCOPE:
Applicable to Disintegration tester
MAKE & MODEL : Electrolab, ED-2AL3.0. RESPONSIBILITY:
3.1. Officer-Quality Control
3.2. Executive-Quality Control4.0. ACCOUNTABILITY:
Manager-Quality Control5.0. DEFINITION:
Tablet disintegration testing is used as a quality-assurance measure. It is not a true predicter of how well the dosage form will release its active ingredient in vivo. The United States Pharmacopea (USP) sets standards for tablet disintegration testing. The apparatus is relatively simple. It consists of a basket rack holding six plastic tubes open at the top and bottom. The bottom is covered with a 10 mesh screen. The rack is immersed in a suitable liquid at 37 degrees C. It moves up and down at a specified rate. One tablet is placed into each tube and the time to disintegrate and fall through the screen is noted.(see Ansel page 192)
6.1. Ensure the calibration status is valid and make sure that the instrument is clean and free from dust.
6.2. Switch on the main switch and put on the ‘ON/OFF’ switch at the rear panel to ‘ ON’ position Follow the procedure to set the
6.3. For setting the temperature select the BATH probe by pressing PROBE key. This key toggles between BATH probe EXTSEL
a) Press SET key – LED to the right of the key will glow.
b) Press TEMP key- Temperature display shows previous set temperature with right most digit flashing.
c) Press ▲ key –Flashing digit value will show increment for every key press. OR
d) Press ▼ key - Flashing digit value will show decrement for every key press. Set the value for flashing digit.
e) Press DISP key - Next significant digit flashes .Repeat the above step.
f) Repeat the step c & d till the desired temperature is set.
g) Press ENTER key –Set temperature value will be registered and SET LED will be off.
To confirm the set value of temperature, press SET key first and TEMP key next. See the set value. Press ENTER key to come out from set mode.
After pressing the SET key one should start the settings within 10 seconds other wise the set mode will be terminated automatically.
Press the TEMP key to start temperature controller. The LED above TEMP key will start glowing.
Select the bath temp indicator using PROBE SEL key. Once the bath temperature reaches the set value , you are ready to start the test by pressing START/STOP key.
There are two modes of operation.
a) Timer mode b) Manual mode
a) Select mode by pressing TIMER key, if the TIMER LED is on, then timer mode is selected. If the TIMER LED is off & Timer display shows “…….. then manual mode is selected. TIMER key toggles between TIMER mode and MANUAL MODE.
In timer mode two time ranges are possible.
1) 1 sec to 99 min & 59 sec.
2) 1 min to 9 hrs & 59 min(if this range is selected the forth (left most) digit of timer display will show “….”).For changing the timer range press SET key first and the ENTER key. Once the test is started range cannot be altered. After range is selected now set the desired time as mentioned. Step No 8.
Timer settings can be done only in timer mode. To set the timer follow the instructions given below.a.
Press SET key- SET LED will start glowing.b.
Press TIMER key – Timer display shows last set value with right most digit flashing. To set the digit go to step cc.
Press ▲ key –Flashing digit value will show increment for every key press.
Press ▼ key - Flashing digit value will show decrement for every key
press. Set the value for flashing digit.d.
Press DISP SEL next significant digit will flash. Now repeat step c to set the value. Repeat step d to set all digits. Press ENTER to accept the value .
Press ENTER key to complete the timer setting. Set LED goes off.f.
Start the test using START/STOP key. TIMER display shows the elapsed time starting from “00.000” if the timer range is min , sec(“-0.00” if the timer range is hrs . min)
In any mode , to START or to STOP the test press the START/STOP key.
Warm distilled water to 37±2°C and take in 1000ml beaker. The volume of the water should be such that the wire mesh of the moving basket at its highest point is at least 25mm below the surface of the liquid and at its lowest point is atleast 25mm above the bottom of the beaker.
Place the beaker in the disintegration test apparatus. Suspend the basket assembly in to the beaker by fixing it in to the moving shaft.
Introduce one tablet in each of the six tubes of the basket of the assembly and place the disc in each.
Press START/ STOP button and note the time.
Run the instrument for required period and switch off. Lift the basket and observe for completion of disintegration.
Empty the beaker and clean.
Remove the discs and clean the disintegration test apparatus.
7.0. REFERENCES: Instrument Manual
8.0. ENCLOSURES: Nil
9.0. ABBREVIATIONS: NilSOP FOR CALIBRATION1.0.PURPOSE :
To provide a procedure for calibrating Disintegration tester. 2.0 SCOPE :
This covers the procedure for calibrating Disintegration tester ( QCI – 21 ).
MAKE & MODEL : Electrolab, ED-2L (USP).3.0 RESPONSIBILITY :
QC officer.4.0 PROCEDURE :4.1 TEMPERATURE CHECK :
4.1.1 Keep about 800 ml of water in 1 liter beaker in the water bath.
4.1.2 Set the temperature to 37°C.
4.1.3 Wait until the set temperature reaches.
4.1.4 Observe and record the temperature,
Acceptance limit : 37°C ± 0.5°C.4.2 STROKE HEIGHT:
4.2.1 Measure the distance between lowest and highest stroke,
Acceptance limit : 53mm to 57 mm.4.3 CYCLES
4.3.1 Count the number of cycles per minute,
Acceptance limit : 28 – 32 cycles/minute.5.0 FREQUENCY OF CALIBRATION :
Once in a month.