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SOP for Cleaning of Auger Filler Machine

OBJECTIVE: 
To lay down a procedure for cleaning of auger filler and sealing machine. 

SCOPE:
This procedure applies for Beta-Lactam production department in Pharmaceutical Manufacturing Facilities. This procedure covers dismantling cleaning and assembling of Dry Syrup Filling & Sealing Machine and its accessories. 
RESPONSIBILITY:
  • The beta-lactam dry syrup filling operator is responsible for implementation of the process. 
  • The Beta-Lactam In-Charge is responsible for the execution and compliance of the procedure. 
PROCEDURE:
Type”A” cleaning procedure (Batch to Batch).
  • Remove the filling nozzle, the auger filler and the filling cylinder. 
  • Clean all the above parts with clean cloth. 
  • Remove the pulsing plates so as to expose fully the conveyor belt. 
  • Clean both pulsing plates and conveyor belt. 
  • Using a Vacuum cleaner, the machine body and hopper should be cleaned. 
  • Clean the floor, walls and glass of Department with soap and water. 
  • Fix the “IN-PROCESS” tag, which indicates the product name, and Batch No & Batch size. 
Product Change Over.
  • Remove the power filler hopper, the filling cylinder, the auger filler, and the powder- filling nozzle. 
  • Remove the pulsing plate so as to expose fully the conveyor belt. 
  • Now clean all the above parts as well as the feeding line, the turntable, the shaft, stirrers and the sealing heads with wet cloth and detergent solution. Rinse with clean water and wipe all the parts with clean dry cloth before reassembling all the parts. 
  • The conveyor should be run during cleaning process so that entire length is cleaned. 
  • Clean the floor, walls and glass of department with soap and potable water finally rinse with purified water. 
  • Fix the status tag indicating “CLEANED” status and dully filled date, previous product details, cleaned by and checked by. 
  • If the cleaned machine is not used within 24 hours or there are signs of dust or powder settled on the outside surface then the exterior of the equipment should be wiped with wet duster followed by clean dry duster. 
  • All the cleaning details shall be entered in the equipment cleaning log.

ABBREVIATION(s): 
Q.A - Quality Assurance 
BL - Beta-Lactam 
SOP - Standard Operating Procedure 
No. - Number 
P.D - Production

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