1.0 OBJECTIVE:
1.1 To describe the procedure for the operation of the Tablet Disintegration Test Apparatus for determining the disintegration time of tablets in accordance with applicable pharmacopeial requirements.
2.0 SCOPE:
2.1 This SOP shall apply to the operation of the Tablet Disintegration Test Apparatus.
3.0 RESPONSIBILITIES:
3.1 Designee Production / Quality Assurance (QA) / Quality Assurance (QC):
3.1.1 Operation, cleaning and documentation.
3.1.2 Shall verify the instrument status before use.
3.1.3 Shall operate the instrument in accordance with this SOP.
3.1.4 Shall record the observations and test results.
3.1.5 Shall clean the instrument after completion of analysis.
3.2 Department Head:
3.2.1 Overall compliance.
3.3 QA Department:
3.3.1 Periodic verification and SOP compliance.
4.0 DEFINATIONS:
4.1 Disintegration Test: A test performed to determine the time required for tablets to disintegrate completely under specified conditions.
4.2 Basket Rack Assembly: Assembly consisting of six glass tubes fitted with a stainless-steel wire mesh at the lower end and operated with a vertical reciprocating movement.
4.3 Guided Disc: A disc placed over the dosage unit, where applicable, to assist uniform disintegration during testing.
5.0 PROCEDURE:
5.1 Before Operation:
5.1.1 Verify that the instrument bears a valid calibration label before use.
5.1.2 Ensure that the instrument is clean and free from any previous sample residue.
5.1.3 Verify that the basket rack assembly, tubes, wire mesh and guided discs are clean and free from damage.
5.1.4 Ensure that the beaker is clean and suitable for the test.
5.1.5 Fill the beaker with the specified immersion medium as described in the approved analytical method or pharmacopeial monograph.
5.1.6 Adjust the immersion medium temperature to 37 ± 2°C or as specified in the approved analytical method.
5.1.7 Ensure that the immersion medium level is sufficient to allow complete movement of the basket rack assembly throughout the test.
5.1.8 Switch ON the mains power supply.
5.1.9 Allow the immersion medium to reach the required temperature before starting the test.
5.2 Operation:
5.2.1 Ensure that the immersion medium has reached the temperature specified in the approved analytical method or pharmacopeial monograph.
5.2.2 Place one tablet into each tube of the basket rack assembly.
5.2.3 Place one guided disc on each dosage unit, where specified in the pharmacopeial monograph.
5.2.4 Position the basket rack assembly inside the beaker containing the immersion medium.
5.2.5 Ensure that the basket rack assembly moves freely without obstruction.
5.2.6 Set the required test time using the SET switch.
5.2.7 Select the desired operating mode (Manual or Auto), where applicable.
5.2.8 Press the START switch to initiate the test.
5.2.9 Verify that the basket rack assembly reciprocates smoothly throughout the test.
5.2.10 The instrument shall operate at 30 ± 1 cycles per minute in accordance with the applicable pharmacopeial requirements.
5.2.11 Observe the operation periodically throughout the test and ensure that no abnormal vibration, noise or interruption occurs.
5.2.12 Upon completion of the pre-set time, the instrument shall stop automatically and an audible alarm shall indicate completion of the test.
5.2.13 If required, the test may be stopped manually by pressing the STOP switch.
5.2.14 If the test is interrupted, it shall be repeated.
5.3 Measurement of Tablet Diameter:
5.3.1 Switch OFF the instrument after completion of testing and remove the basket rack assembly from the instrument.
5.3.2 Remove the guided discs from the tubes and empty the immersion medium from the beaker.
5.3.3 Wash the basket rack assembly, glass tubes, guided discs and beaker using purified water.
5.3.4 If required, clean the components using a suitable laboratory detergent followed by thorough rinsing with purified water.
5.3.5 Dry all components using a clean lint-free cloth or allow them to air dry.
5.3.6 Clean the external surfaces of the instrument using a clean damp cloth followed by a dry cloth.
5.3.7 Do not allow water to enter the electrical components or control panel.
5.3.8 Do not use abrasive cleaning materials or corrosive chemicals on the instrument.
5.3.9 Record instrument usage in the instrument logbook.
6.0 RFERENCE:
6.1 Instrument User Manual
6.2 British Pharmacopoeia / US Pharmacopoeia
7.0 RECORDS:
Sr No. Title Nature of Document Document No.
NA NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01