1.0 Objective: To lay down a procedure for the operation of a tablet inspection belt.
2.0 Scope: This procedure is applicable to the operation of tablet inspection belt in production area.
3.0 Responsibility:
Operator, Officer, Executive – Production Department
Manager – Production Department
4.0 Definition:
NA
5.0 Procedure:
5.1 Operation:
5.1.1 Ensure the cleanliness of equipment and area.
5.1.2 After line clearance from QA, put the ‘’UNDER PROCESS’’ label duly filled and signed on the machine and record the observations by using the “equipment usage log sheet” SOP.
5.1.3 Turn ‘ON’ the main switch from the panel board.
5.1.4 Load the tablets/capsules into the hopper with Scoop and switch on the machine.
5.1.5 Adjust the vibration of the hopper to the optimum level so that the tablets/capsules pass freely from the hopper and avoid the overflow of the tablets/capsules.
5.1.7 Check out for defective tablets like broken, capping, chipping, oil or black spots, sticking, mottling, orange peel appearance, etc.
5.1.8 Check out for defective capsules like unlocked, telescopic, dented appearance, etc.
5.1.9 Stop the belt by using leg brakes and remove the defective tablets/capsules and collect it into the SS trays provided with recovery labels.
5.1.10 After inspection, check the weight of defective and correct tablets/capsules.
5.1.11 Record the observations in the equipment usage log sheet as per the given SOP.
5.1.12 Switch ‘OFF’ the main power supply from the electric panel.
5.1.13 Affix duly filled and signed the “TO BE CLEANED” label on the machine.
5.2 Precaution:
5.2.1 Ensure the rotation of the belt in the forward direction.
5.2.2 Ensure the proper rolling of the tablet on the belt.
6.0 Abbreviations:
BMR: Batch Manufacturing Record
HDPE: High-Density Poly Ethylene
IPC : Inprocess Container
QA: Quality Assurance
SS: Stainless Steel
7.0 Reference:
NA
8.0 Annexure:
Nil
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