Capsule Polishing Machine, Purpose :
Capsule Polishing Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Capsule Polishing Machine (Model: SF-40N) in order to comply with cGMP standard.
Capsule Polishing Machine, Scope :
The scope of the procedure is applicable to the Capsule Polishing Machine (Model: SF-40N) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Set up, operation and cleaning of the Polishing Machine (Model: SF-40N)
[][]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
Annexure:
N/A.
Procedure
Precautions :
[][]Make sure that the main power switch is OFF position before and after operation.
[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Before entering the capsule polishing room use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during polishing operation.
[][]Do not insert hands inside the hopper during operation.
[][]Make sure that capsule is not deposited in hopper and other parts of the machine that must be observed very carefully.
[][]In case of emergency, press the emergency switch of the main encapsulation machine to stop the machine.
Machine Assembling
[][]Set the capsule polishing brush by specific nut and attach the SS cover of the machine.
[][]Set the capsule hopper.
[][]Fixed the empty capsule shell feeder on the machine.
[][]Set the air pressure of the machine.
Machine Operation
[][]Turn ON the main switch of the machine. Then turn ON the switch of the capsule polishing machine.
[][]Turn on the air pressure valve and adjust the air pressure 0.15 to 0.2 bars.
[][]Load the capsule on the hopper.
[][]Check the capsule is polishing accurately.
[][]Continue the polishing operation if capsule polishing is accurate.
[][]Turn OFF all switch gradually after complete the polishing operation.
[][]Record the machine operation parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Turn the main switch OFF.
[][]Collect the dust from the hopper by vacuum cleaner.
[][]Dismantle the parts like hopper, machine cover, brush and empty shell feeder and transfer them to the wash bay.
Machine Cleaning
[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the hopper 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 like capsule polishing brush.
[][]Finally rinse the machine body, all product contact parts, holding screw and capsule polishing brush with purified water and dry the brush properly after cleaning.
[][]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 in the ‘Equipment Log Book.
Annexure:
Annexure I Equipment Use Log Book