Dispensing Booth, Purpose :
Dispensing Booth, The purpose of this SOP is to describe the operation and cleaning procedure of Dispensing Booth (Model: Standard) in order to comply with cGMP standard.
Dispensing Booth, Scope :
The scope of the procedure is applicable to the Dispensing Booth (Model: Standard) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Operation and cleaning of the Dispensing Booth (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
Annexure:
[][]N/A.
Procedure
Precautions:
[][]The working person must follow safety procedures of works.
[][]For any trouble, disturbance switch OFF the Dispensing Booth.
Machine Operation
[][]Check the machine first physically.
[][]Check electric connection and mechanical set up.
[][]Machine switch on.
[][]Light on and blower on.
[][]Open the door.
[][]After completion desired work clean the Laminar Unit properly.
[][]Close the door and switch off main switch.
[][]Switch ON Dispensing Booth.
[][]Switch ON Light.
[][]Switch ON the Laminar Air Flow.
[][]Increase or decrease air flow by pressing up/down button.
[][]Warm up the Dispensing Booth for 30 minutes before starting dispensing.
[][]Record the machine operation start time & end time and other parameters on the ‘Equipment Log Book’
Machine Cleaning
[][]Remove dusts from the dispensing booth with a vacuum cleaner and then clean with lint free cloth.
[][]Use wet cloth to clean the booth.
[][]Wipe the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’