Tablet Metal Detector ,Purpose:
Tablet Metal Detector , The purpose of this SOP is to describe the setting, operation and cleaning procedure of MET 30+ Pharmaceutical Metal Detector Machine in order to comply with cGMP standard.
Tablet Metal Detector , Scope:
The scope of the procedure is applicable to the MET 30+ Pharmaceutical Metal Detector Machine at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Operation and cleaning of the MET 30+ Pharmaceutical Metal Detector
[][]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 :
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Ensure Electric line is properly connected.
Machine Assembling
[][]Set the discharge chute into the main body of the machine.
[][]Set the rejected tablet containing bucket in the lower part of the machine.
[][]Adjust the alignment of the machine with respect to main machine.
[][]Ensure all the settings are properly done.
Machine Operation
[][]Connect electrical cable to the machine.
[][]Switch ON the main power of the machine.
[][]Set the programs from the control panel of the machine.
[][]Pass the tablet through the discharge chute and reject the tablet having metallic content.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Switch OFF the main power of the machine.
[][]Remove the discharge chute.
[][]Remove the bucket from the lower part 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.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts.
[][]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