SOP for Operating Procedure of Disintegration Apparatus

OBJECTIVE

To lay down a procedure for the operation of the disintegration apparatus.

SCOPE

This procedure applies to the QC department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The IPQA Supervisor is responsible for the implementation of the process.

The QC In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

• Fill the beaker to 1 liter with a specified medium (water, stimulated gastric fluid, or stimulated intestinal fluid) and switch on the power supply.
• Reset the alarm switch to the required time for the test.
• Set the temperature of the medium and allow it to stabilize in the range of 36^°C to 38^°C.

• Introduce one tablet or capsule into each tube and if prescribed in the product’s monograph add a disk to each tube.
• Suspend the assembly in the beaker and reset the timer to ‘00’, then switch on the motor.

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• After the specified time switch off the motor and mains and remove the assembly from the liquid.
• The tablets or capsules pass the test if all six have disintegrated and passed through the 10-mesh screen and none adheres to the lower surface of the disc if a disc has been used in the time specified. Enteric-coated tablets are to show no evidence of disintegration after 1 hour in simulated gastric fluid.
• Change the liquid and clean the apparatus after every test.

REFERENCE

Nil.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

ºC: Degree Celsius

IPQA: In-process quality assurance

ANNEXURE

Nil.

REVISION HISTORY

Nil.

ALSO READ: SOP for Cleaning Procedure for Disintegration Test Apparatus