SOP on Cleaning of Tablets Compression Machine
SOP on Cleaning of Tablets Compression Machine
1.0 Objective: To describe a cleaning procedure for the tablets compression machine.
2.0 Scope: To ensure that the equipment is clean and free from any starting materials of previous batch or product residues.
3.0 Responsibility :
3.1. It is the responsibility of operating staff to clean the equipment.
3.2. Production Chemist to ensure that procedure is followed.
4.0 Materials & Equipment:
4.1. Cleaning agent: Isopropyl Alcohol / Methylene Chloride and Water ( for hopper / feed frame)
4.2. Vacuum Cleaner / brush / lint free cloth
5.0 Procedure
5.1 Switch off the mains of compression machine.
5.2 Remove the visible material from the tablet compression machine with the help of a vacuum cleaner
5.3 Dismantle hopper & feed frame and clean with a dry lint free cloth and then with tap water & finally with DM water & dry with lint free cloth.
5.4 Remove the left over powder from the turret with the help of a nylon brush and vacuum cleaner.
5.5 Clean the turret with a dry lint free cloth.
5.6 Dismantle the dies and punches and place them in a plastic tub.
5.7 Clean the entire machine giving particular attention to feed frame, hopper, dies and punches with a dry lint free cloth.
5.8 Dip the dies and punches in isopropyl alcohol / methylene chloride and clean / wipe with a dry lint free cloth.
5.9 Apply a thin film of food grade oil on entire surface and store dies and punches in the respective boxes.
5.10 Switch on the machine and run the machine for 4 to 5 minutes. Clean the turret of the machine and die holes with a nylon brush and isopropyl alcohol / methylene chloride.
5.11 Clean the compression machine by mopping with a dry lint free cloth and blow clean air with the help of air compressor to remove traces of solvent.
5.12 Reassemble the cleaned hopper and feed frame on the machine and put a label “Clean” or “Ready for use”.
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