Material Drying Machine , Purpose :
Material Drying Machine , The purpose of this SOP is to describe the setting, operation and cleaning procedure of Material Drying Machine (Model: Standard) in order to comply with cGMP standard.
Material Drying Machine , Scope :
The scope of the procedure is applicable to the Material Drying Machine (Model: Standard) 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 Drying Machine (Model: Standard)
[][]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 individual tray and machines inner part during assembling of machine.
[][]Booth side doors are in lock position during operation.
[][]Check the air outlet damper position before and after completion of operation.
Machine Assembling
[][]Keep the necessary change parts near the material dryer machine before assembling.
[][]Assemble the dryer by opening the front side door of the dryer.
[][]Load the tray with material and place into the tray holding rack.
[][]Then set the rack carrying trolley.
[][]Then place the tray holding rack into the machine.
[][]After that closed the door accurately with the help of door locking handle.
[][]Then closed the air outlet damper and tight the screw accurately.
Machine Operation
[][]Switch ON the main power switch.
[][]Open the plastic cover and set the desire temperature of the machine.
[][]Then open the plastic cover and set the desire time of the machine.
[][]At first switch ON the blower of the machine.
[][]Then switch ON the heater of the machine.
[][]After completed the drying time open the air outlet damper for material cooling and check the LOD.
[][]After operation switch OFF the heater and then blower. Unload the tray holding rack from the machine.
[][]Finally switch OFF the main power of the machine.
[][]Record the machine operation parameters in the ‘Equipment Log Book’.
Machine Dismantling
[][]Open the both side door of the machine.
[][]Unload the tray holding rack from the machine with the help of carrying trolley.
[][]Remove the tray from the rack.
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 and other machine parts.
[][]Use hot water to clean all the trays.
[][]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