Standard cleaning procedure for cleaning of tablet compression machine.
1.0 Purpose
The purpose of this SCP is to develop a standard procedure for cleaning of tablet compression machine.
2.0 Scope
This SOP is applicable for the procedure used for cleaning of tablet compression machine in the tablet manufacturing area.
3.0 Responsibility
3.1 Machine operator is responsible for cleaning the tablet compression machine.
3.2 The Production officer is responsible for implementing this SOP.
3.3 The head of production is responsible for ensuring the implementation of this SOP.
3.4 Q.A Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Turn the machine off and remove the power plug from the electric socket.
4.2 First of all remove the feeders, discharging chute & hoppers of the compression machine and shift these to the washing area.
4.3 Wash these parts with portable water and then wash with 1% food grade detergent and finally wash with purified water.
4.4 Take the water sample from parts and send it to QA for checking pH and conductivity.
4.5 Dry all these washed parts with lint free cloth and store all these washed parts in a cleaned equipment cabinet.
4.6 Collect all the powders from the compression machine turret with the help of a vacuum cleaner.
4.7 Now remove the safety guards and uninstall all the punches and dies.
4.8 Remove oil/grease from all the punches,shafts, pressure rollers,cams with the help of lint free cloth.
4.9 Clean all punch holders,die houses,cams, pressure roller,guards with 70% IPA using nylon brush and lint free cloth.
4.10 Now wash the punches and dies with the help of 70% IPA and clean these with lint free cloth.
4.11 Apply food grade oil to the punches and dies and store in the punch storage room.
4.12 Bring the next tooling set to be installed from the tool room.
4.13 Verify the dimensions of all the punches and wash punches & dies with 70% IPA to remove the food grade oil.
4.14 Install all the punches and dies after cleaning with lint free cloth and fix the safety guards.
4.15 Bring the hoppers, feed frames and discharging chutes from the storage cabinet.
4.16 Disinfect with 70% IPA and install on the compression machine.
4.17 Record the cleaning activity in the logbook.
5.0 Precautions
5.1 Don’t run the machine in jog mode while cleaning.
5.2 Rotate the turret by using a manual rotating wheel.
5.3 Don’t install punches and dies without dimensions verification
6.0 Abbreviations
6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance