ROPP Cap Sealing Machine, Purpose :
ROPP Cap Sealing Machine, The purpose of this SOP is to describe the Operation and cleaning procedure of ROPP Cap Sealing Machine (Model: PPM-35) in order to comply with cGMP standard.
ROPP Cap Sealing Machine, Scope :
The scope of the procedure is applicable to the ROPP Cap Sealing Machine (Model: PPM-35) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Setting, operation and cleaning of the Cap Sealing Machine (Model: PPM-35)
[][]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:
Precaution:
[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during sealing operation.
[][]In case of emergency, press the emergency switch to stop the machine.
Machine Assembling
[][]Set the base of the machine by specific nut and attach the bottle adjuster.
[][]Set the sealing wheel according to the neck diameter of the bottle.
[][]Fix the bottle size by moving the base.
Machine Operation
[][]Load the bottle on the SS table.
[][]Fix the plastic stopper and aluminum cap on the empty bottle.
[][]Turn on the main switch of the machine.
[][]Take a bottle on the base.
[][]Seal it by the moving sealing wheel.
[][]Check the leakage by leak test apparatus.
[][]If sealing is accurate then another eight empty bottle have to seal.
[][]Take them again for leak test.
[][]Continue the sealing operation if sealing is accurate.
[][]Turn off the all switch gradually after complete the sealing operation.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Turn the main switch off.
[][]Dismantle the parts like moving sealing wheel, bottle adjuster unit and transfer them to the wash bay.
Machine cleaning
[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body and holding screw.
[][]Use hot water to clean all the product contact parts & finally rinse with purified water.
[][]Clean and swab all the parts with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’.