Material Pulverization Machine, Purpose :
Material Pulverization Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Material Pulverization Machine (Model: 30B) in order to comply with cGMP standard.
Material Pulverization Machine, Scope :
The scope of the procedure is applicable to the Material Pulverization Machine (Model: 30B) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Sep Up, Operation and cleaning of the Material Pulverization Machine (Model: 30B)
[][]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 main power switch is OFF position before and after operation.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Check the cleanliness of sieves, ss container, tray 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 machine before assembling.
[][]Assemble the machine by opening the front side cover of the machine.
[][]Adjust the sieve into the ring with the help of screw.
[][]Then set the sieve ring into the machine.
[][]Close the cover of the machine properly.
[][]Set the filter bag of the machine with the help of spring and clamp.
[][]Place the tray under the filter bag.
Machine Operation
[][]Switch ON the main power switch.
[][]Switch ON the blower by pressing green button of the machine.
[][]Then switch ON the motor by pressing green button of the machine.
[][]Input the material through the hopper of the machine manually.
[][]Sieve the material and collect sieved material through the cover discharge opening.
[][]After operation first switch OFF the motor then switch OFF the blower by pressing red button.
[][]Record the machine operation parameters in the ‘Equipment Log Book’.
Machine Dismantling
[][]Open the front cover of the machine.
[][]Remove the sieve ring of the machine.
[][]Remove the filter bag of the machine.
[][]Remove the tray of the machine.
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, tray, container, sieve & filter bag.
[][]Use hot water to clean all the product contact parts such as sieve ring.
[][]Finally rinse the machine body, product contact parts, trays 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’.
Annexure:
Annexure I Equipment Use Log Book