Electric Stirrer , Purpose :
Electric Stirrer, The purpose of this SOP is to describe the Operation, cleaning and maintenance procedure of Electric Stirrer (Model: ES) in order to comply with cGMP standard.
Electric Stirrer , Scope :
The scope of the procedure is applicable to the Electric Stirrer (Model: ES) 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 Electric Stirrer (Model: ES)
[][]Maintaining operation and cleaning log book
Executive/ Sr. Executive 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.
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
[][]Attach required sieve in the sieve holding clamp of the machine.
[][]Attach bolts and tighten the knobs to ensure that the sieve is properly installed in the machine.
[][]Rotate the shaft clamp to loosen the main shaft.
[][]Push the shaft downward to lower the main shaft and pull the shaft upward to rise the main shaft holding the propeller and sieve.
[][]Rotor the shaft clamp anticlockwise to tighten the main shaft.
[][]Ensure that the main shaft is properly tightened before running the machine. Donot run the machine if the shaft is not properly tightened.
[][]Check for all the bolts to be tightened properly.
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.
[][]Adjust the secondary propeller according to the need of the liquid to be stirred. If secondary propeller is not required adjust it higher than the liquid lavel.
[][]Make sure that both propeller is submerged in the liquid to be stirred.
[][]Push the Forward button to rotate the propeller clockwise and push the backward button to rotate the propeller 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 60 in the screen the machine tends to rotate in 2800 RPM. Do not run the machine more than 1400 RPM that is 30 in the screen.
[][]To stop the machine push the stop button and the machine will stop automatically.
Machine Dismantling
[][]Disconnect the machine from the main electric supply.
[][]Rise the main shaft from the liquid. Remove the remaining liquid(if any) from the sieve holding clamp and remove the solution preparation mug.
[][]Loosen the sieve holding bolts, remove the sieve and take in a poly bag
[][]Loosen the primary propeller with the help of a range, and remove from the machine.
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]Clean the sieve holding clamp, secondary propeller and the main shaft of the machine with lint free cloth wiped in potable water.
[][]Repeat the procedure twice to remove all solution from the machine.
[][]Clean the secondary propeller and the clamp with brush to remove any part of the solution adhering to the machine.
[][]Rub gently with lint free cloth to remove any solution adhering to the machine.
[][]Wipe the cloth in hot water and rub the machine, Clean all the machine parts with hot water, then finally rinse with purified water.
[][]Clean the motor covering , Main shaft and the base of the machine with potable water, Rub the parts with lint free cloths wipe din potable water than rinse with purified water.
[][]Wipe the machine with dried lint free cloth to remove water from the machine. Use compressed water to remove water as necessary.
[][]Submerge the sieve and the primary propeller in potable water for 10 minutes.
[][]Clean the parts with tap water to remove any part of the solution.
[][]Use brush and lint free cloth to properly clean the parts.
[][]Submerge the parts in hot water, Clean the parts with hot water finally rinse with purified water.
[][]Rub the machine parts with lint free cloths and compressed air to remove water.
[][]Take the dried sieve and the sieve holding bolts in a poly bag attach a cleaned label and store in the cabinet.
[][]Install the propeller in the main shaft. Attach a Cleaned label in the machine.
Annexure:
Annexure – I: Operation and cleaning log book.