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SOP for Cleaning Procedure of Double Cone Blender

OBJECTIVE
To lay down a procedure for cleaning of double cone blender.

SCOPE
This procedure applies for production department in Pharmaceutical Manufacturing Facilities of XYZ Limited, Formulation division. This procedure covers cleaning of double cone blender.

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

PROCEDURE
Type “A” Cleaning Procedure (Batch to Batch Change Over):
  • Switch ‘OFF’ the electrical mains of the blender.
  • Remove all powder from blender by inverting it and tapping if need be. Wipe the surface with clean free duster. Clean the floor, walls and glass partition with liquid soap and rinse with clean water. Attach a status label to indicate that the machine has been ‘CLEANED’.

Type “B” Cleaning Procedure (Product to Product Change Over):
  • Disconnect the equipment from electrical main supply.
  • Remove the lid by unclamping the nuts.
  • Keep the blender in vertical position and keep a container double lined with polythene below it.
  • Clean the container internally & externally with liquid soap. Drain all the water from the bottom lid and rinse with Purified Water BP.
  • Clean the lid & gasket with water and liquid soap and then rinse with Purified Water BP.
  • Finally rinse blender and all parts with Purified Water BP and dry it with lint free duster.
  • Clean the floor, walls and glass partitions of the department with liquid soap and rinse with clean water.
  • Assembling- Fix the cleaned gasket, lid to the blender. Fix the cleaned label after checking cleanliness of blender duly sign by production officer. Cover the clean blender with appropriate cloth body cover.
  • 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 dry duster.
  • All the cleaning details shall be entered in the equipment cleaning log.

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

ANNEXURE(s)
Nil.

REVISION HISTORY
Nil

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