Bottle Drying Machine, Purpose :
Bottle Drying Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Glass Bottle Drying Machine (Model: Standard) in order to comply with cGMP standard.
Bottle Drying Machine, Scope :
The scope of the procedure is applicable to the Glass Bottle 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 Glass Bottle 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 tray with glass bottle 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 bottle cooling and check the bottle.
[][]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
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