Standard Operating Procedure (SOP)

Here is a complete Standard Operating Procedure (SOP) for Operation and Cleaning of Co-Mill (Cone Mill)—a commonly used equipment in the pharmaceutical industry for particle size reduction and granule uniformity. This SOP includes cleaning, safety, and operational guidelines.

1.0 Objective

To describe the procedure for operation, cleaning, and maintenance of the Co-Mill used in the granulation and milling processes.

2.0 Scope

This SOP applies to the Co-Mill (Cone Mill) used in the wet and dry granulation process for size reduction at [Company Name].

3.0 Responsibility

4.0 Definitions

• Co-Mill: A milling machine used to reduce granules to uniform particle size via gentle shearing action.

• Screen: A metal mesh used inside the cone to determine the final particle size.

• Impeller: Rotating part inside the cone that pushes material against the screen.

5.0 Materials and Tools Required

• Clean lint-free cloth

• Approved cleaning solution (e.g., 2% Teepol)

• Purified water

• Cleaning brushes (non-metallic)

• Stainless steel containers/trays

• PPE (gloves, mask, apron, goggles)

• “To Be Cleaned” / “Cleaned” status tags

6.0 Procedure

6.1 Operation

1. Ensure the equipment is clean and labeled “Cleaned”.

2. Check all parts are assembled correctly: cone, impeller, screen, discharge chute, etc.

3. Verify the screen size as per the Batch Manufacturing Record (BMR).

4. Connect the electrical supply and ensure earthing is intact.

5. Feed material slowly into the hopper using a scoop or vacuum transfer.

6. Switch ON the main power and start the machine using the control panel.

7. Monitor feed rate and avoid overloading.

8. After milling, switch OFF the machine and disconnect the power supply.

9. Collect the milled product in labeled SS containers.

6.2 Cleaning Procedure (Post-Batch or Product Changeover)

Dismantling and Cleaning:

1. Affix “To Be Cleaned” label on the equipment.

2. Disconnect from power supply and dismantle:

   • Hopper

   • Impeller

   • Cone screen

   • Discharge chute

3. Rinse all parts with purified water to remove product residue.

4. Wash parts using 2% cleaning solution, scrub with a brush.

5. Rinse with purified water until no foam remains.

6. Dry parts with lint-free cloth or allow to air dry in clean area.

7. Wipe the external body of Co-Mill with 70% IPA or disinfectant.

8. Inspect all parts for cleanliness and damage.

9. Reassemble the machine and affix “Cleaned” label.

10. Record cleaning activity in the Equipment Cleaning Logbook.

7.0 Cleaning Frequency

• After every batch

• Between product changeovers

• After any prolonged equipment idle time (as per SOP)

8.0 Safety and Precautions

• Always wear PPE before operation or cleaning.

• Do not operate the machine with wet hands or loose clothing.

• Ensure screen and impeller are correctly positioned before switching ON.

• Never put hands near rotating parts.

• Use proper tools for assembly/disassembly.

9.0 Documentation

• Equipment Usage Log

• Cleaning Logbook

• Batch Manufacturing Record (BMR)

• Status Labels (Cleaned / To Be Cleaned)

10.0 Abbreviations

• SOP: Standard Operating Procedure

• SS: Stainless Steel

• IPA: Isopropyl Alcohol

• BMR: Batch Manufacturing Record

• QA: Quality Assurance

11.0 Annexures

• Annexure 1: Equipment Cleaning Checklist

• Annexure 2: Equipment Usage Log Format

🎓 Discover one of the best Pharmaceutical Production courses available — click below to explore the course that’s shaping future Production skills.

https://trcjw.on-app.in/app/oc/338669/trcjw