Standard Operating Procedure for tablet inspection machine.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for operating the tablet inspection machine.
2.0 Scope
This SOP is applicable to the procedure of operating the tablet inspection machine used for sorting the tablets in the manufacturing area.
3.0 Responsibility
3.1 Inspection machine operator is responsible for operating the tablet inspection machine.
3.2 Production Pharmacist is responsible for the implementation of this SOP.
3.3 The HOP is responsible for ensuring the implementation of the current SOP.
3.4 Q.A Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 The inspection machine operator shall ensure that the tablet inspection room is properly cleaned and labeled.
4.2 The inspection machine operator shall ensure that the hopper,trays,feeder of machine and moving conveyor belt are clean and clear.
4.3 Take line clearance from the Production and Quality Assurance officer for starting the tablet sorting using an inspection machine.
4.4 After line clearance, adjust the hopper,feeder and trays of the inspection machine.
4.5 Plug in the electric supply and press ON button to turn the conveyor belt On.
4.6 Adjust the speed of the conveyor belt and turn On the lights for inspection.
4.7 Open the drum of tablets and remove tablets from the drum with a stainless bowl and load to the hopper of the tablet inspection machine.
4.8 Turn On the vibratory mechanism of the hopper to ensure uniform flow of tablets for checking.
4.9 Inspection team shall check the tablets for defects like
- Broken tablets
- Black particles
- Capping, lamination
- Sticking, picking
- Low hardness,rough surface
- Poor embossing, mottling
- Twinning,logo bridging
4.10 Remove defective tablets and place them in the polythene labeled as rejected tablets.
4.11Transfer the ok tablets in a cleaned drum having a double polythene bag and labeled with good tablets.
4.12 At the end of the inspection process weigh the rejected tablets and waste them as per waste disposal note.
4.13 Write the weight of ok tablets and rejected tablets in the BMR.
4.14 The production officer shall reconcile the yield.
4.15 Transfer the container of ok tablets to the inprocess storage area.
4.16 Record the activity in the logbook.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 HOP:Head Of Production.