Bottle Washing Machine, Purpose :
Bottle Washing Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Glass Bottle Washing Machine (Model: IRW-16) in order to comply with cGMP standard.
Bottle Washing Machine, Scope :
The scope of the procedure is applicable to the Glass Bottle Washing Machine (Model: IRW-16) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Set up, operation and cleaning of the Washing Machine (Model: IRW-16)
[][]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 water reserve tank and machines inner part during assembling of machine.
[][]Do not touch the hot water tank during operation.
[][]Check the individual bottle washing nozzle working properly.
Machine Assembling
[][]Keep the necessary change parts near the bottle washing machine before assembling.
[][]Assemble the washing machine by bottle holder.
[][]Load the pump 1 with tap water and pump 2 with hot water.
[][]Load the bottle holder with glass bottle.
[][]Set the nozzle’s spray rate of tap water and purified water depending on the glass bottle size.
Machine Operation
[][]Switch ON the main power switch.
[][]Switch ON the heater switch of the machine and wait 20 minutes for hot water (60ºC).
[][]Then press the START button of the main motor.
[][]After press the START button of the pump 1.
[][]Then press the START button of the pump 2.
[][]Open the valve of compressed air line.
[][]After completing the glass bottle washing procedure close the valve of tap water, purified water & compressed air line.
[][]After operation switch OFF the heater, pump 2, pump 1 and then main motor.
[][]Finally switch OFF the main power of the machine.
[][]Record the machine operation parameters in the ‘Equipment Log Book’.
Machine Dismantling
[][]Open the cover of the machine.
[][]Remove the bottle holder of the machine.
[][]Drainage the water of pump 1 & pump 2.
Machine Cleaning
[][]Remove dusts from the machine body and other necessary parts with a vacuum cleaner.
[][]Use potable water to clean the machine body, product contact parts and other machine parts.
[][]Use hot water to clean all the parts.
[][]Finally rinse the machine body, product contact parts 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