1.0 OBJECTIVE:
To lay down the procedure for Operation of Rotary tablet press ZP-17 for proper and continuous compression of tablets from granulated material.
2.0 SCOPE:
This SOP shall be applicable for the operation of Rotary tablet press ZP-17 in compression area at Production department of Pharmaceutical Industry.
3.0 RESPONSIBILITY:
3.1 Supervisor/ Machine Operator.
3.2 Production Pharmacist.
4.0 ACCOUNTABILITY:
4.1 Manager-Production department.
5.0 MATERIAL AND EQUIPMENT:
5.1 Rotary tablet press Machine.
6.0 PROCEDURE:
6.1 Start-up & Operation:
6.1.1 Before starting the machine carefully inspect the punches and dies that their edges should be sharp without kink, cracks or deformation and they are properly mounted.
6.1.2 Before mounting the dies and punches ensure that the machine is free by rotating manually and also ensure that the rotation is correct.
6.1.3 Inspect that the granulated material is dry and the water context present is within limits.
6.1.4 Pour the material into the feed hopper, turn the turret by handle wheel manually and regulate the file and pressure until the desired weight and hardness of the tablets is obtained.
6.1.5 Start the motor and engage the clutch to proceed with operation.
6.1.6 During the operation regularly inspect the quality of the tablets produced. If any fault is found necessary adjustment should be made.
6.1.7 Adjust the speed of the machine as required.
6.1.8 During operation if any abnormal noise is heard, stop the machine at once to locate the cause and remedy to trouble.
6.2 Stop-Over:
6.2.1 Switch off the machine.
6.2.2 Switch off the main power supply.
6.2.3 Remove any left-over powder from the feed hopper.
6.2.4 Remove punches and dies if new batch is to be started.
6.2.5 Carry out cleaning procedure as described earlier.
6.2.6 Affix “To be Cleaned” label & fill the “Equipment Log Book”.
6.3 Precautions:
6.3.1 All protective guards of the machine should never be removed during operation.
6.3.2 Moist material should never be used, because it will stick on the punches.
6.3.3 Never pick the tablets with fingers while the machine is running to avoid accident.
6.3.4 Never operate the machine in the opposite direction because this can cause damage to the machine and dies and punches.