Standard Operating Procedure (SOP)

Here is a comprehensive Standard Operating Procedure (SOP) for the Cleaning and Operation of a Comminuting Mill (also known as a Multi Mill or Cone Mill), commonly used in pharmaceutical manufacturing for size reduction, granulation, or wet/dry milling.

1.0 Objective

To lay down a standard procedure for the operation and cleaning of the Comminuting Mill to ensure its correct use, consistent performance, and compliance with Good Manufacturing Practices (GMP).

2.0 Scope

This SOP applies to the Comminuting Mill used for dry and wet granulation, and size reduction in the production department of [Company Name].

3.0 Responsibility

4.0 Definitions

• Comminuting Mill: Equipment used for reducing particle size by using a rotating blade and sieve mechanism.

• Sieve/Screen: A mesh used to control the size of output granules or particles.

• Impeller/Blade: The rotating component that drives material through the sieve.

5.0 Materials and Tools Required

• Lint-free cloths

• Clean potable water and purified water

• Approved detergent or cleaning agent

• Brushes (non-metallic)

• PPE: gloves, mask, apron, goggles

• Cleaning and operation logbook

6.0 Operation Procedure

6.1 Pre-Startup Checks

1. Verify that the Comminuting Mill is clean and the “Cleaned” label is affixed.

2. Ensure the correct sieve and impeller are installed as per BMR.

3. Check for free rotation of the impeller.

4. Ensure all clamps, locks, and fasteners are secure.

5. Plug in the power cord and check for safe electrical connections.

6. Affix a status label: “Ready to Use”.

6.2 Operating Steps

1. Start the machine by pressing the main power switch.

2. Load the material through the feed hopper gradually.

3. Adjust the feed rate to avoid choking.

4. Monitor the output material for uniformity.

5. If vibration or abnormal noise occurs, stop the machine and report.

6. After batch completion, switch off the machine and disconnect from the power source.

7.0 Cleaning Procedure

7.1 Type of Cleaning

• Product Changeover Cleaning

• Batch-to-Batch Cleaning (if same product)

• Periodic/Deep Cleaning

7.2 Cleaning Steps

1. Disconnect the machine from the power source.

2. Dismantle parts: hopper, impeller, screen, and discharge chute.

3. Remove any adhered material using a dry cloth or brush.

4. Wash all product-contact parts with detergent solution (as per cleaning SOP).

5. Rinse thoroughly with purified water.

6. Wipe all parts dry with lint-free cloth.

7. Clean the non-contact parts (body, stand) with a damp cloth.

8. Allow to dry completely, then reassemble the parts.

9. Inspect cleanliness and affix a “Cleaned” status label.

10. Record cleaning activity in the Equipment Cleaning Logbook.

8.0 Frequency of Cleaning

• After each batch or product change

• Daily, if in continuous use

• After any maintenance or repair

9.0 Safety and Precautions

• Always wear PPE during operation and cleaning.

• Do not operate with loose clothing or wet hands.

• Never insert hands into the hopper while machine is in use.

• Ensure machine is off and unplugged before cleaning or maintenance.

• Use only authorized tools and approved cleaning agents.

10.0 Documentation

• Equipment Operation Log

• Equipment Cleaning Log

• Breakdown/Maintenance Record

• Changeover Checklist

11.0 Abbreviations

• SOP: Standard Operating Procedure

• QA: Quality Assurance

• BMR: Batch Manufacturing Record

• PPE: Personal Protective Equipment

12.0 Annexures

• Annexure 1: Equipment Cleaning Checklist

• Annexure 2: Equipment Operation Log Sheet

• Annexure 3: Changeover Record Template

🎓 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