Container blender, Purpose:
Container blender, The purpose of this SOP is to define the operation and cleaning procedure of container blender.
Container blender, Scope:
This SOP is applicable for operation and cleaning procedure of container blender in product development of XX Pharmaceuticals Limited.
Definition / Abbreviation:
[][]None
Responsibilities:
[][]The roles and responsibility are as follows:
Operator/Supervisor Product Development
[][]Operation and cleaning of the container blender
[][]Maintaining operation and cleaning log book
Executive/ Senior 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, Quality Assurance
[][]Ensure that the SOP reflects actual operation and cleaning procedure.
[][]Approve the SOP against XX Pharmaceuticals Limited master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
Machine Assembling
[][]Before operation assemble the machine accessories that are necessary for operation.
[][]Place the container at the holding arm of the blender. Then, secure it with the holding arm.
[][]Securely close and lock of inlet ports and outlet port in place.
[][]Test whether container rotates smoothly without any abnormal noise after activation. Check that rotation direction is correct according to the arrow sign.
Machine Operation
[][]Connect the power cable to the socket for power supply.
[][]Turn the machine ON/OFF switch (main switch at the right down corner of the machine) to ON. Control panel light will illuminate and the machine is ON.
[][]Unclamp and open the inlet port cover.
[][]Load raw materials into the chamber. Total material load should not exceed the maximum working volume and the minimum working volume.
[][]Securely close the mixing chamber cover and clamp.
[][]Release the EMERGENCY SWITCH, MIXER STOP SWITCH will light up, indicating that the electricity is supplied to the control system and the machine is ready to perform the process.
[][]Set Timer process according to the timer required for the mixing process.
[][]Activate the mixer.
[][]Observe carefully, there is no abnormal noise generated by the blender.
[][]Ensure that there is no leakage in inlet valve and outlet valve during the mixing.
[][]Check that the timer counts down the time. Once the set time is reaches, the mixer will stop operation accordingly.
[][]Place a collection bin under the outlet port. Plastic or clothing bag might be wrap between outlet port and other collection bin to prevent product dispersion into the room.
[][]Open the outlet valve to discharge the product into a collection bin. Open the inlet port to check whether there is any remaining product inside the container.
[][]Shut the outlet port after all product removed.
[][]In case of manual operation set TIMER OFF/ON selector to OFF. And activate the blender.
[][]Push EMERGENCY SWITCH button to discontinue the electrical supply to the system.
[][]Clean the machine as per above cleaning procedure.
[][]Turn the machine ON/OFF button to OFF. The machine light will be OFF.
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]Place the drain tank under the discharge port.
[][]Ensure the discharge port is securely closed.
[][]Check again there is no material inside the container.
[][]Fill the container until half of the mixing chamber with normal water.
[][]Securely close the inlet port.
[][]Activate the machine to rotate at low speed first before accelerate the speed.
[][]After a while, check inside the chamber whether machine residue is fully dissolved and suspended or not. If not, start the blender rotation again.
[][]Repeat the procedure until it is done.
[][]Now discharge the water with dissolved materials.
[][]Now hot water is applied inside the chamber to remove materials fixed hardly on the chamber surface.
[][]Wash the machine with wet marking cloth.
[][]Re-wash the machine with purified water as required. Finally rinse with purified water.
[][]Clean inlet ports, discharge port, mixing chamber and external surface with damp cloths.
[][]Wipe the water droplets with cloth, and dry the machine with compressed air.
[][]Fix ‘CLEANED’ label on the machine.
[][]Keep the record of machine operation and cleaning according to the Annexure – I of this SOP.
Annexure:
Annexure – I: Operation and cleaning log sheet of Container Blender