SOP for Cleaning of Multi Mill

1. Objective

To establish a validated procedure for cleaning the Multi Mill to prevent cross-contamination and ensure compliance with current Good Manufacturing Practices (cGMP).

2. Scope

Applicable to all Multi Mill equipment used in pharmaceutical production.

3. Responsibility

• Production Operator: Execute the cleaning procedure.

• Quality Assurance (QA): Verify and document the cleaning process.

4. Types of Cleaning

• Type A: Batch-to-batch cleaning.

• Type C: Product-to-product changeover cleaning.

5. Cleaning Procedure

5.1 Preparation

• Update the equipment status label to “TO BE CLEANED”.

• Switch off the main power supply.

• Cover electrical components with polythene to prevent water ingress.

• Remove any residual materials and labels from the previous batch.

5.2 Dismantling

• Detach the feeding hopper, chamber cover, screen guard, blades, and rotor by loosening the respective nuts and bolts.

• Transfer all dismantled parts to the designated washing area, labeling them appropriately.

5.3 Cleaning of Dismantled Parts

• Rinse each part with potable water to remove loose residues.

• Scrub with a 2.5% Teepol solution to eliminate adhered materials.

• Rinse thoroughly with potable water, followed by a rinse with purified water.

• Apply hot water to the parts and allow them to drain.

• Wipe each part with a dry, lint-free cloth and then with 70% Isopropyl Alcohol (IPA).

5.4 Cleaning of Main Body and Surrounding Area

• Use a vacuum cleaner to remove any powder residues from the machine body.

• Wipe the machine surfaces with a lint-free cloth dampened with purified water, followed by 70% IPA.

• Clean the surrounding area, including walls and floors, with appropriate disinfectants

5.5 Reassembly

• Once all parts are dry, reassemble the Multi Mill in the reverse order of dismantling.

• Ensure all components are securely fitted and functioning correctly.

5.6 Documentation

• Update the equipment logbook with cleaning details, including date, time, and personnel involved.

• Affix a “CLEANED” status label on the equipment.

• If the equipment is not used within 72 hours post-cleaning, re-cleaning is required.

• Always wear appropriate Personal Protective Equipment (PPE) during the cleaning process.

• Ensure that cleaning agents are handled according to their Material Safety Data Sheets (MSDS).

• Dispose of waste materials in compliance with environmental regulations.

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