Multi mill , Purpose :
Multi mill , The purpose of this SOP is to describe the Operation and cleaning procedure of Multi Mill (Model: GMP) in order to comply with cGMP standard.
Multi mill , Scope :
The scope of the procedure is applicable to the Multi Mill (Model: GMP) at the Product Development area of XX Pharmaceuticals Pvt. Limited.
Definitions / Abbreviation:
[][]None
Responsibilities:
[][]The roles and responsibility is as follows:
Operator/Supervisor Product Development
[][]Operation and cleaning of the Multi Mill (Model: GMP)
[][]Maintaining operation and cleaning log book
Officer/ Sr. Officer Product Development
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Checking the log book.
[][]Preparation and timely review of the SOP.
Assistant Manager Engineering
[][]Preparation of maintenance schedule and maintenance of the machine.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation, cleaning and maintenance procedure.
[][]Approve the SOP against XX Pharmaceuticals Ltd. Master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
Machine Assembling
[][]Loosen the knobs of the Discharge covering. Anticlockwise rotation of the knobs will loosen and clockwise rotation will tighten the discharge unit
[][]Remove the discharging unit from the machine. Rotate the covering slightly at any direction and pull downward to remove smoothly.
[][]Rotate the screws of the Mesh holding plate anticlockwise direction to loosen the plate. Rotate the plate anticlockwise and remove from the machine.
[][]Check for the proper tightening of the knife and knife holding shaft.
[][]Set desired mesh on the mesh slot, push upward to set the mesh properly.
[][]Install the mesh holding plate, tighten the mesh holding plate properly. Do not run the machine without properly tightening the knobs.
[][]Install the Discharge unit in the, tighten all the knobs of the discharge unit to properly set the machine.
[][]Check for the proper positioning, functioning and installation of the hopper, feed controlling plate and the hopper covering.
Machine Operation
[][]Connect the main electric supply with the socket.
[][]Three lights (Red, Green and Yellow) illuminates to show the proper functioning of the three phase connection of the machine.
[][]Remove the covering of the hopper to charge the materials in the hoper. Keep the feed control plate fully closed while charging the materials.
[][]Pull the feed control plate outward to control the material entry in the milling zone.
[][]Install the hoper covering, do not run the machine without the covering installed properly.
[][]Push the Forward button to rotate the blades clockwise and push the backward button to rotate the blades anticlockwise.
[][]To stop the machine instantly push the stop button.
[][]To switch from forward rotation to backward rotation first push the stop button and when the machine is stop then push the backward button.
[][]Do not switch directly from one rotational direction to another direction.
[][]Display will show the RPM of the machine, do not change any parameter in the inverter. Changing parameters in the inverter will stop the machine immediately.
[][]To change or adjust the machine speed use the speed controlling regulator. Clockwise rotation will increase the RPM and anticlockwise rotation will decrease the RPM.
[][]When the display shows 28 in the screen the machine tends to rotate in 1400 RPM. Machine can be run in more speed than that, but don’t run the machine in speed more than 28 in display.
[][]To stop the machine instantly push the stop button and the machine will stop automatically.
Machine Dismantling
[][]Disconnect the machine from the main electric supply.
[][]Remove the Hopper cover and the feed control plate from the machine.
[][]Loosen the screws in the hopper than remove the hopper from the machine.
[][]Rotate the knobs in the discharge unit, rotate the discharge unit than pull downward to remove the discharge unit from the machine.
[][]Rotate the knobs in the mesh holding tray anticlockwise to loosen the screws. Rotate the knobs anticlockwise and remove the tray.
[][]Pull the mesh downward to separate the mesh from the machine.
[][]Use a socket set to remove the knife shaft from the machine.
[][]Loosen the screw on the downward of the machine.
[][]Pull the shaft backward. The shaft with the knives will come out.
[][]Remove the pin holding cap on the top of the shaft.
[][]Pull out the pins from the shaft.
[][]Remove the knives and the scrapers by pulling them in outer direction.
Machine Cleaning
[][]After removal and dismantling of all change parts take the change parts in the cleaning bay.
[][]Use vacuum cleaner to remove any remaining powder from the machine body.
[][]Wash the machine body, shaft, basement and motor holding portion wish wet lint free cloth.
[][]Wash the machine with hot water if necessary, then finally rinse the machine with wet cloth submersed in purified water.
[][]Dry the machine with dried lint free cloth. Use compressed air if necessary to remove water from the critical places.
[][]Clean the wire with wet cloth and dry using lint free cloths.
[][]Clean all the change parts with potable water, use cloth to rub well to remove any portion of powder from the machine.
[][]Use hot water to clean all the machine parts, use nylon brush if necessary to remove any remaining quantity of powder dust
[][]Use nylon brush to clean the knives and brush through the knife shaft to remove any portion of powder.
[][]Run the whole procedure twice for knife and knife holding shaft.
[][]Rinse the parts with purified water. Dry all the change parts with lint free dried cloth, Use compressed air to remove water from the critical areas.
[][]Use compressed air to remove the water from the knife holding zone in the shaft.
[][]Attach the knives with the shaft and lock with the pin
[][]Attach pin holding top to keep the pin in position.
[][]Fix the knife shaft in the machine and tighten with the socket set, check for the proper fixing of the machine.
[][]Attach the sieve holding plate and the discharge unit with the machine
[][]Install the hopper, feed control plate and the hopper covering in the machine. Attach a CLEANED label in the machine.
[][]Clean the sieve with potable water, use dump cloth to properly remove powder.
[][]Use hot water to clean the sieve properly, use nylon brush to remove any quantity of powder.
[][]Rinse the sieve with purified water, dry the sieve with dried lint free cloth, use compressed water first to remove the water from the sieve then use lint free cloth to dry the sieve.
[][]Take the sieve in a poly bag, attach a cleaned label in the bag and store in the cabinet for machine change parts.
Annexure:
Annexure – I: Operation and cleaning log book.