SOP Tablet Inspection

OBJECTIVE:To lay down a procedure for smooth operation of the Tablet inspection machine and Tablet inspection process.

SCOPE:This SOP is applicable for Tablet inspection process and Operation of the Tablet inspection machine used for inspection of compressed tablets to detect and remove defected tablets from the batch.

REFERENCE:User manual.

RESPONSIBILITY:Production Supervisor and Operator

Production Head

ABBREVATIONS:

SOP: Standard Operating Procedure

SCP: Standard Cleaning Procedure

QA: Quality Assurance

PROCEDURE:

1. Operation of Tablet inspection machine

1.1 Ensure that the machine is clean and bearing the CLEANED status label.

1.2 Switch ON the supply mains from the main junction box.

1.3 Switch ON the Main Supply, on the control panel.

1.4 Load the Tablets in the hopper.

1.5 Switch the Vibrator Selector switch to ON position.

Two Position ON / OFF Switch for the Vibrator

1.6 Switch the conveyor selector switch to ON position.

1.7 Switch on the Roller Selector Switch to ON position.

1.8 The tablets in the vibrator tray vibrate due to vibrator and excessive powder on the tablets falls into the dust collector tray through the perforations on the vibrator feed tray.

1.9 The tablets from the vibrator further passes from the tablet aligner to the moving

conveyor with the help of vibratory motion.

1.10 Switch on the Inspection Lamp Switch, to switch on the tube light for better

illumination.

1.11 Further the tablet passes to the inspection zone where the tablet gets rolled with the rollers, it is inspected visually and the side portion is inspected in the mirror of the machine.

Inspection Mirror

Rotating Rollers in the Inspection area (Shown with red ellipse)

1.12 Press the foot switch

By pressing the foot switch on the machine, the Foot Switch lamp glows with green indication. The rollers in the inspection zone, rotates in anticlockwise direction so that the rejected tablet won’t travel further.

1.13 The rejected tablet is picked up and put in the Reject collection tray.

Reject collection tray

1.14 To switch OFF the machine, switch off vibrator, roller and conveyer first then switch off the inspection lamp and at last the mains.

1.15 Once the operation is done clean the machine as per SCP.

2. Tablet Inspection Process

2.1 Inspection of tablets is one of the most important stages which give a correct idea about defects in the tablets which are directly correlated with process of tablet manufacturing.

2.2 All the workmen inspecting the tablets must wear the nose masks and fresh pair of hand gloves to avoid the cross contamination.

2.3 Ensure that all the material from the previous batch (Tablets, Polythene bags, gloves etc.) is removed from the area

2.4 Ensure that line clearance taken from QA before starting the activity.

2.5 Prepare separate polythene bags for recovery tablets and rejected tablets and label them accordingly. Place a new polythene bag on the inspection table.

2.6 Operate the Tablet inspection machine as per procedure given above (1.1 to 1.15).

2.7 Inspect the tablets for the defects such as broken tablets, rough surface, edged tablets, capped tablets, shade variation, hair cracks and black spots.

2.8 Collect the defective tablets in the rejection tray and then sort them as recoverable and rejected.

2.9 Weigh the inspected tablets, recovery tablets and the rejected tablets and enter in the BMR.

2.10 Destroy the rejected tablets as per the SOP/P/QA/03.

FREQUENCY:

After completion of Tablet compression process or as and when required.

ANNEXURE:

Nil