1.0 OBJECTIVE
1.1 To lay down a procedure for operation of Disintegration test apparatus, Make: Electrolab
2.0 RESPONSIBILITY
2.1 Technical Assistant / Production Executive / IPQA Executive – To perform as per SOP
2.2 Production / QA in-charge – To ensure the compliance
3.0 PROCEDURE
3.1 Operation
3.1.1 Switch on the mains.
3.1.2 Press the START/STOP switch on the rear right hand side of the instrument base.
3.1.3 TIMER key is a toggle key to set Timer mode or Manual mode of operation. Incase of Manual mode the display shows ‘——’ and the apparatus run irrespective of the set time value. Incase of the Timer mode the apparatus is switched off automatically after the set time value of the test..
3.1.4 Check that the water bath is filled with purified water up to the level marked.
3.1.5 Beakers are filled with freshly collected purified water, adjust the volume of purified water , such that when the assembly is in highest position the wire mesh is at least 15mm below the surface of purified water and when the assembly is in lowest position the wire mesh is at least 25mm. above the bottom of the beaker and upper ends of the tubes remains above the surface of purified water.
3.1.6 Set the temperature in the following procedure.
- Set the temperature 37 ± 20C , unless specified in the BPRR.
- Press “SET” Key.
- Press “TEMP” Key.
- Press “DISP. SEL” Key to select the digit to be changed.
- Press either “D” or “Ñ“ Key to attain the desired temperature.
- Press “ENTER” Key to set the temperature.
- The “TEMP” key is a toggle key used to start and stop the temperature controller.
3.1.7 Set the time in the following procedure.
- Select the timer in MIN: SEC range by pressing the key SET, ENTER simultaneously. Incase of HRS: MIN the display shows a “-” before time.
- Press “SET” Key.
- Press “TIMER” Key.
- Press “DISP. SEL” Key to select the digit to be changed.
- Press either “D” or “Ñ”key to attain the desired temperature.
- Press “ENTER” Key to set the timer.
- “START / STOP” key is toggle key for the timer.
3.1.8 After completing the parameter settings start the temperature controller by pressing “TEMP” key.
3.1.9 Select the bath temperature indicator using PROBE / SEL key. Once the bath temperature achieves the set value the instrument is ready to use.
Precaution
The external probe should be handled carefully. When the external probe is not in use, keep it in the place provided for it on the bath
3.1.10 Press the START / STOP key to start the test.
3.1.11 Take sufficient quantity of tablets / capsules to be tested as per the BPRR.
3.1.12 Place one tablet / capsule in each cylinder of the basket followed by disc ( If required )
3.1.13 Observe the tablet / capsule to disintegrate completely through the mesh.
3.1.14 Press START / STOP Key to stop after complete disintegration of tablet / capsule.
3.1.15 Record the time shown in the timer in BPRR.
3.1.16 Remove the basket assembly from the hook arm and replace the water in the beaker before proceeding for next test.
3.2 CLEANING
3.2.1 After Every Test :
3.2.1.1 Switch off the power supply before starting the cleaning activity.
3.2.1.2 Remove the basket assembly by disengaging from the hook arms and remove the beakers from the acrylic water bath.
3.2.1.3 Wash the beakers, baskets, discs and top plate with purified water.
3.2.1.4 Wipe the body of the disintegration test apparatus using lint free cloth dipped in purified water.
3.2.1.5 Collect purified water in beakers and reassemble the beakers and baskets.
3.2.2 Weekly Cleaning :
3.2.2.1 Switch off the power supply before starting the cleaning activity.
3.2.2.2 Remove the basket assembly by disengaging from the hook arms and remove the beakers from the acrylic water bath.
3.2.2.3 Disconnect the heating coil plug to the water bath from rear side of the apparatus.
3.2.2.4 Detach the water bath from the apparatus base
3.2.2.5 Wash the water bath, beakers, baskets, discs and top plate with purified water.
3.2.2.6 Wipe the body of the disintegration test apparatus using lint free cloth dipped in purified water.
3.2.2.7 Collect purified water up to the marked level and reassemble the water bath and top plate in the reverse procedure of dismantling.
3.2.2.8 Collect purified water in beakers and reassemble the beakers and baskets.
3.2.2.9 Update the status label as “CLEANED”.
3.2.2.10 Switch off the power supply of the instrument after the days operation.
PRECAUTION
- Make sure that the heater is connected properly.
2. Do not try to remove the basket until it is disengaged from the hook arm.
4.0 ABBREVIATIONS
Nil
5.0 REFERENCES
Nil
6.0 ANNEXURES
Nil
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