Vibratory Sifter, Purpose :
Vibratory Sifter, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Vibratory Sifter Machine (Model: BT-800-3S) in order to comply with cGMP standard.
Vibratory Sifter, Scope :
The scope of the procedure is applicable to the Vibratory Sifter Machine (Model: BT-800-3S) at the Production area of General block of Labaid Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
The Roles and Responsibilities are as follows:
Operator
Operation and cleaning of the Vibratory Sifter Machine (Model: BT-800-3S)
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
Precautions :
[][]Make sure that the power cable is separated from the socket before and after operation.
[][]The sifter covers and lid are in lock position during operation.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Check the cleanliness of sifter, sieves and gasket before assembling of machine.
[][]Check the sieve for its integrity before and after completion of operation.
Machine Assembling
[][]Keep the necessary change parts near the sifter machine before assembling.
[][]Assemble the sifter by putting cover with discharge opening on top of body of sifter.
[][]Then set the clamp to tighten the cover.
[][]Then place required sieve.
[][]On the top of first cover set the second cover with discharge opening.
[][]Set the clamp to tighten the second cover.
[][]Place the required sieve.
[][]Set the third cover with discharge opening.
[][]Set the clamp.
[][]Set the lid cover of sifter.
[][]Set the clamp.
Machine Operation
[][]Connect the power cable to the socket for power supply.
[][]Switch on the machine by pressing green button on the lower part of the machine.
[][]Input the material through the lid opening.
[][]Sieve the material and collect sieved material through the cover discharge opening.
[][]After operation switch off the sifter machine by pressing red button on the lower part of machine.
[][]Record the machine operation parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Remove the clamp of lid cover.
[][]Remove the lid cover.
[][]Remove the clamp of third cover.
[][]Remove the third cover.
[][]Remove the clamp of second cover.
[][]Remove the second cover.
[][]Remove the sieve.
[][]Remove the clamp of first cover.
[][]Remove the cover.
[][]Remove the sieve.
Machine Cleaning
[][]Remove dusts from the machine body and other necessary parts with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, product contact parts, clamps and other machine parts.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, product contact parts, clamps and other machine parts with purified water.
[][]Remove the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’