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SOP for Operating Procedure of Communiting Mill


OBJECTIVE 

To lay down a procedure for operation of Communiting mill. 

SCOPE 
This procedure applies for production department in Pharmaceutical Manufacturing Facilities Formulation division. 

RESPONSIBILITY 
The production operator is responsible for implementation of the process. 
The production In-Charge is responsible for the execution and compliance of the procedure. 

PROCEDURE 
Pre checks
  • Availability of trained operating personnel wearing clean uniform, gloves and nose mask. 
  • Availability of power supply. 
  • Availably of clean SS container to collect milled material. 
  • Ensure the cleanliness of area and machine with proper labeling and line clearance. 

Machine assembling
  • Assemble the screen, screen plate, and Discharge port. 
  • Fix the perforated screen as per the product requirement along with base plate. 
  • Check whether the gaskets are in good condition and are placed properly. 
  • Clamp Feed-Discharge port and slide plate. 
Operation
  • Switch ‘ON’ the mains. 
  • Set the speed of blade as mentioned in BMR. 
  • Run the Communiting mill empty for few seconds and observe for any abnormal sound. If noticed then switch OFF the mains and reassemble the parts. 
  • Arrange SS container lined with double polybag; tie the polybag to the discharge hopper to avoid dust. 
  • Switch ‘ON’ the mains. Charge the material into the feed hopper with the help of clean SS scoop. 
  • Open slide plate slowly and control the flow of the inlet material. 
  • Optimum output can be obtained by maintaining a constant rate of feeding. 
  • Do not overload the Blade; otherwise the Motor or Belt will be damaged 
  • While Operating Machine, ensure that guards & blades are properly closed otherwise it will give major physical injury to the operating personnel. 
  • All the operation details shall be entered in the equipment usage logbook.
ABBREVIATION(s) 
Q.A - Quality Assurance 
BL - Beta-Lactam 
SOP - Standard Operating Procedure 
No. - Number 
P.D - Production

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