Cone Blender, Purpose:
Cone Blender, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Cone Blender Machine (Model: DB-150) in order to comply with cGMP standard.
Cone Blender, Scope:
The scope of the procedure is applicable to the Cone Blender Machine (Model: DB-150) at the Production area of General block of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Operation and cleaning of the Cone Blender Machine (Model: DB-150)
[][]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:
Precaution:
[][]The cone is in lock position.
[][]Keep the hydraulic trolley near to the machine.
[][]Keep the doors of lower chamber closed during operation and after completion of job.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
Machine Assembling
[][]Lock the double cone.
[][]Change the sieve of dry granulator as specified in Batch Manufacturing Record (BMR).
[][]Open the lid of double cone.
[][]Move the dry granulator to the open end of the double cone.
[][]Ensure the proper adjustment of dry granulator and double cone.
[][]Lift the product container with hydraulic trolley to adjust with the container holder.
[][]Lock the product container with the container holder.
[][]Lift the product container to the granulator head.
[][]Move the product bowl and granulator out to the normal position.
[][]Close double cone cover lid.
[][]Unlock double cone and rotate it.
Machine Operation
[][]Set the parameters such as time & rotation per minute.
[][]Start granulator and transfer the product by passing through the granulator with desired sieve to double cone.
[][]After completion of milling close the lid
[][]Unlock double cone and rotate it.
[][]When the Process stops, the double cone will incline because of product. User have to press “JOG” button to swing or arrange double cone to straight in lock position and then lock it.
[][]Open guard bar and remove lower cone by trolley then move product out.
[][]Record the machine operation start time & end time and other parameters on the ‘Equipment Log Book
Machine Dismantling
[][]Remove lower cone from the machine.
[][]Remove the dry granulator.
Machine Cleaning
[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the product cone, dry granulator and operation panel and machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts, holding screw and other parts with purified water
[][]Clean and swab with lint free cloth all the parts and the machine body to dry any water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’