SOP for Cad Mill
1.0 Purpose
To describe the procedure for operation, cleaning, and maintenance of the Cad Mill to ensure consistent particle size reduction and compliance with cGMP requirements.
2.0 Scope
This SOP applies to the Cad Mill installed in the production area of [Company Name], used for granule size reduction during manufacturing.
3.0 Responsibility
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Production Operator: To operate and clean the Cad Mill as per this SOP.
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Production Supervisor: To ensure proper usage and verify log entries.
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Engineering: For maintenance and repair of the equipment.
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Quality Assurance (QA): To verify cleaning and ensure compliance.
4.0 Definitions
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Cad Mill / Cone Mill: A size reduction equipment that uses a conical screen and impeller for uniform particle size distribution.
5.0 Procedure
5.1 Operation
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Ensure the equipment is clean and a “Cleaned” status label is affixed.
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Assemble the Cad Mill with the required screen and impeller as per the BMR.
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Check the tightness of clamps and ensure safety guards are in place.
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Switch on the main power supply.
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Feed granules uniformly into the hopper.
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Operate the impeller at the required speed (low/medium/high) as per the process requirement.
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Collect the processed granules from the discharge port in labeled containers.
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Avoid overfeeding to prevent choking of the mill.
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After completion, switch off the machine and main power supply.
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Record the operation details in the equipment usage logbook.
5.2 Cleaning
Type A – Batch-to-Batch Cleaning
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Disconnect the main power supply.
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Remove the hopper, impeller, screen, and discharge chute.
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Clean all contact parts with a nylon brush and rinse with purified water.
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Wash with 1% detergent solution, followed by thorough rinsing with purified water.
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Dry all parts with a lint-free cloth or hot air.
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Reassemble the equipment.
Type B – Product Changeover Cleaning
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Perform all steps of Type A cleaning.
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Wipe external surfaces with 70% IPA.
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Verify cleanliness visually and through swab test (if applicable).
Type C – Weekly / Periodic Cleaning
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Perform detailed cleaning of non-contact parts, motor housing, and external body.
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Inspect for wear, damage, or buildup inside screens and impellers.
5.3 Maintenance
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Preventive maintenance to be carried out as per engineering schedule.
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Inspect motor, bearings, and impeller for smooth operation.
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Replace damaged or worn-out screens and impellers.
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Record maintenance in the equipment history card.
6.0 Safety Precautions
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Do not operate without proper guards.
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Never insert hands or tools into the hopper during operation.
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Always disconnect power before cleaning or maintenance.
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Wear gloves, goggles, and mask while operating.
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Ensure no metallic objects are fed into the mill.
7.0 Documentation
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Equipment usage logbook
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Cleaning record
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Preventive maintenance record
8.0 References
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Equipment manufacturer’s manual
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cGMP guidelines
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Batch Manufacturing Record (BMR)
9.0 Abbreviations
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SOP: Standard Operating Procedure
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BMR: Batch Manufacturing Record
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cGMP: Current Good Manufacturing Practices
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IPA: Isopropyl Alcohol
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