Standard Operating Procedure (SOP)

1. Purpose

To define the standard procedure for the operation, cleaning, and maintenance of the Cage Blender used for blending dry powders or granules to achieve a uniform mix.

2. Scope

This SOP applies to the operation and cleaning of the Cage Blender in the manufacturing area.

3. Responsibility

• Machine Operator: Operate and clean the cage blender according to this SOP.

• Production Supervisor: Ensure SOP compliance and verify cleaning.

• QA/QC: Review and approve cleaning and usage records.

4. Materials and Equipment Required

• Cage Blender

• Approved batch materials (powders/granules)

• Personal Protective Equipment (PPE)

• Cleaning materials: lint-free cloths, brushes, approved detergent, purified water

• Logbooks and batch records

5. Procedure

5.1 Pre-Operational Checks

• Ensure the blender is clean, dry, and labeled “Cleaned.”

• Inspect the cage and bin for cleanliness and any damage.

• Check the locking and clamping system of the bin.

• Verify all safety interlocks are functional.

• Confirm the area is clean and the environment is controlled.

• Check power supply and machine readiness.

5.2 Operation Procedure

1. Preparation:

   • Wear appropriate PPE (mask, gloves, apron, cap).

   • Ensure the bin is properly loaded with the required materials as per batch sheet.

   • Close and lock the bin lid securely.

2. Mounting the Bin:

   • Bring the loaded bin to the blender using a pallet or trolley.

   • Align and lock the bin inside the cage securely.

   • Ensure the bin clamp is tightly secured.

3. Blending:

   • Switch on the power supply.

   • Set the rotation time and speed as per batch manufacturing record.

   • Start the blender.

   • Monitor for unusual sounds or vibrations.

   • Once blending is complete, stop the blender.

4. Post-Blending:

   • Unlock and remove the bin.

   • Transfer it to the next process area.

   • Document the operation in the equipment usage log.

5.3 Cleaning Procedure

1. Dry Cleaning (Between Batches of the Same Product):

   • Remove residual powder using a vacuum or dry lint-free cloth.

   • Inspect and record status.

2. Wet Cleaning (Between Products or After Batch Completion):

   • Dismantle parts if necessary.

   • Wash all contact surfaces with approved detergent and brushes.

   • Rinse thoroughly with purified water.

   • Dry all parts using lint-free cloths or allow to air dry in a clean area.

   • Reassemble the blender.

   • Affix “Cleaned” status label with date and signature.

   • Record cleaning activity in the logbook.

6. Safety Precautions

• Ensure proper locking of the bin to avoid accidents.

• Do not open any part of the equipment while it is in motion.

• Always wear PPE while operating or cleaning.

• Use caution when handling heavy bins.

• Follow lockout/tagout procedures for maintenance.

7. Documentation

• Equipment Usage Log

• Cleaning Logbook

• Batch Manufacturing Record

• Preventive Maintenance Record

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