Dialysis Fluid Filling Machine, Purpose :
Dialysis Fluid Filling Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of filling machine in order to comply with cGMP standard.
Dialysis Fluid Filling Machine, Scope :
The scope of the procedure is applicable to the filling machine at the production area of dialysis Fluid unit of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]LAF = Laminar Air Flow.
[][]PVC = Polyvinyl Chloride.
Responsibilities :
[][]The roles and responsibilities are as follows:
Operator
[][]Operation and cleaning of the filling machine.
[][]Maintaining equipment log book.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Head of Plant Operation
[][]To agree the laid down procedure.
Head of Quality Assurance
[][]To approve the SOP
Procedure :
Precautions :
[][]Use face mask, rubber gloves and protective clothing during filling operation.
[][]Turn ON LAF before filling operation.
[][]Connect electric line properly.
[][]Filling vessel valves are in open position.
[][]Check any leakage from discharge valve, silicon pipe and filling piston.
Machine Assembling :
[][]Clean the machine well with lint free cloth.
[][]Assemble the machine change parts and all the connections that are necessary for certain types of Operation.
[][]Attach tightly the silicon pipe (2’’) to the storage vessel (2000L).
[][]Attach tightly the solution transfer pipe (1½’’) to the dosing unit.
[][]Covert the filling machine by the PVC curtain.
Machine Operation:
[][]Lock the chamber lid cover of 200L vessel properly.
[][]Turn the transfer pump ON/OFF key to ON.
[][]Transfer 2000 L solution from storage vessel (2000 L) by opening the gate valve of storage vessel.
[][]This system is done by product filling end times.
[][]Turn the filling machine ON/OFF key to ON.
[][]Placed two containers under the dosing nozzle pipe
[][]Wait for two dosing rotation per container (5Liters/Stroke) then push OFF button.
[][]Look the actual filling volume of the containers.
[][]Push the OFF button of filling machine if container supplies insufficient or any other problems.
[][]Check the solution during filling by looking at the vision area of lid cover.
[][]Transfer or sample the solutions by opening the sampling port valve manually.
[][]Push the OFF button to stop the machine and plug out the main electric line to its main.
[][]Record the machine start time, end time and other parameters in the ‘Equipment Log Book’
Machine Dismantling :
[][]Turn the machine ON/ OFF key to OFF the machine.
[][]Remove the solution transfer pipe and filling pipe manually.
[][]Remove the lid cover and turn OFF the stirring.
[][]Remove the electric industrial plug.
Machine Cleaning :
[][]Clean the machine with lint free cloth to remove dust.
[][]Clean the inner elevation of the filling machine by using potable water.
[][]Clean the inner elevation of the filling machine by using hot water.
[][]Clean the inner elevation of the filling machine by using purified water through pipe.
[][]Clean the outer elevation of the filling machine with potable water by rubbing with a lint free cloth.
[][]Soak with a clean dried lint free cloth to remove the water from the filling machine.
[][]Clean all of the machine parts with potable water, hot water then purified water.
[][]Soak with a clean dried lint free cloth to remove the water from the machine parts.
[][]Affix the clean label on the filling machine as ‘CLEANED’.
Annexure:
Annexure I Equipment Use Log Book