Auger Filling Machine, Purpose :
Auger Filling Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Auger filling Machine (Model: GZF30B) in order to comply with cGMP standard.
Auger Filling Machine, Scope :
The scope of the procedure is applicable to the Auger filling machine (Model: GZF30B) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]PLC = Programmable Logic Controller.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Setting, operation and cleaning of the Auger filling Machine (Model: GZF30B)
[][]Maintaining Equipment Log Book
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Procedure:
Precaution:
[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Before entering the filling room use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during filling operation.
[][]Do not insert hands inside the hopper during operation; keep the hopper closed after loading.
[][]Make sure that powder is not deposited in hopper, dosing unit and other parts of the machine that must be observed very carefully.
[][]In case of emergency, press the emergency switch to stop the machine.
Machine Assembling
[][]Set the dosing unit by specific nut and attach the supporting parts of dosing unit.
[][]Set the powder hopper with its supporting parts.
[][]Fix the size of the bottle on the machine.
[][]Set the parameters of the machine such as Set Quantity, Actual Quantity and Output on the PLC.
Machine Operation
[][]Load the bottle on the SS table.
[][]Load the powder in hopper and close the lid of hopper.
[][]Turn on the main switch of the machine.
[][]Turn on the vibrator switch.
[][]Mix the powder in the hopper by rotating stick.
[][]Set the filled weight on the PLC.
[][]Adjust the filled weight by pressing leg punch in the empty glass bottle.
[][]Check the fill weight of eight bottles after setting the volts in dose wheel.
[][]Continue the filling operation if fill weight is accurate.
[][]Turn off the all switch gradually after complete the filling operation.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Turn the main switch off.
[][]Collect the powder from the hopper and dosing unit by vacuum cleaner.
[][]Dismantle the parts like hopper, auger and dosing unit and transfer them to the wash bay.
Machine cleaning
[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the hopper, dosing unit, operation panel and machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts, holding screw and other parts with purified water.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book.
Annexure:
Annexure I Equipment Use Log Book