Dust Collector , Purpose:
Dust Collector , The purpose of this SOP is to describe the setting, operation and cleaning procedure of Dust Collector in order to comply with cGMP standard.
Dust Collector , Scope:
The scope of the procedure is applicable to the Dust Collector at the Production area of of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Setting, operation and cleaning of the it
[][]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:
[][]Machine Assembling
[][]Open dust collectors lid.
[][]Set the filter bag inside the Machine.
[][]Set the upper lid cover of the Machine.
[][]Connect the dust collecting hose pipe.
Machine Operation
[][]Connect electrical cable of it.
[][]Connect ithose pipe with Tablet Compression Machine.
[][]Switch ON the main power of it from the PLC of the compression machine.
[][]Record the operation start time & end time and other parameters on the ‘Equipment Log Book’
Machine Dismantling
[][]Switch OFF the compression Machine.
[][]Remove electrical connection.
[][]Remove dust collecting hose pipe from compression Machine.
[][]Remove the upper lid of the it.
[][]Remove the filter bag.
Machine Cleaning :
[][]Remove dusts from the machine with a duster.
[][]Use potable water to clean the machine body and filter bag.
[][]Finally clean with purified water.
[][]Clean and swab with lint free cloth all the parts and the machine body to dry any water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’
Annexure:
Annexure I Equipment Use Log Book