Tablet Dedusting Machine, Purpose:
Tablet Dedusting Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of SEJONG Tablet Dedusting Machine in order to comply with cGMP standard.
Tablet Dedusting Machine, Scope:
The scope of the procedure is applicable to the SEJONG Tablet Dedusting Machine at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Setting, operation and cleaning of the Machine
[][]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:
Precaution :
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Ensure electric and air line are properly connected.
[][]Machine Assembling
[][]Set the perforated plate in machine.
[][]Fixed the upper lid properly by holding screw.
[][]Ensure all the screws are connected properly.
Machine Operation
[][]Connect electrical cable of Dedusting Machine to the main compression machine.
[][]Connect compressed air line to Dedusting Machine.
[][]Switch ON the main power of Dedusting Machine.
[][]Adjust the vibration level by tuning volume.
[][]During tablet compression tablet passes through the discharge chute of compression machine to the Dedusting machine.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Switch OFF the main power of the Dedusting Machine.
[][]Remove the compressed air line from the Dedusting Machine.
[][]Open the upper lid of the machine.
[][]Remove the perforated plate of the machine.
Machine Cleaning
[][]Remove dusts from the machine with a vacuum cleaner.
[][]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’