STANDARD OPERATING PROCEDURE (SOP)

1.0 OBJECTIVE

To establish a standard procedure for the cleaning of equipment and accessories used in the production area to ensure cleanliness, prevent cross-contamination, and maintain product quality.

2.0 SCOPE

This SOP applies to all production equipment and accessories used in manufacturing operations at [Company Name].

3.0 RESPONSIBILITY

• Production Operators: To perform cleaning as per SOP.

• Production Supervisor: To verify cleaning and maintain records.

• QA Personnel: To inspect and approve equipment post-cleaning.

4.0 MATERIALS AND EQUIPMENT REQUIRED

• Lint-free cloths

• Nylon brush

• Detergent solution (validated cleaning agent)

• Purified Water

• 70% Isopropyl Alcohol (IPA)

• Designated cleaning tools (marked as “Clean” or “To Be Cleaned”)

• PPE: gloves, face mask, gown, goggles

• Cleaning tags

• Logbook or cleaning checklist

5.0 PROCEDURE

5.1 General Precautions

• Wear appropriate PPE before starting cleaning.

• Ensure the equipment is switched OFF and disconnected from power.

• Remove any remaining product material and label as per status (e.g., “To Be Cleaned”).

5.2 Cleaning of Equipment

1. Disassemble all removable parts.

2. Dry Clean: Remove powder/dust using a dry cloth or vacuum.

3. Wet Clean:

   • Wash parts with warm water and approved detergent.

   • Scrub using nylon brushes to remove product residues.

   • Rinse thoroughly with purified water.

4. Sanitization:

   • Wipe surfaces with 70% IPA.

   • Allow to air dry or dry with lint-free cloth.

5. Reassembly:

   • Reassemble only after all parts are completely dry.

   • Perform visual inspection for cleanliness.

5.3 Cleaning of Accessories

• Clean scoops, spatulas, containers, and other small tools similarly.

• Use designated cleaning station for small items.

5.4 Post-Cleaning

• Attach a “Cleaned” status label with date, time, and initials.

• Record cleaning details in the Equipment Cleaning Logbook.

6.0 CLEANING FREQUENCY

• After every batch

• During product changeover

• After maintenance or repair

• As per validated frequency schedule

7.0 RECORDS TO BE MAINTAINED

• Equipment Cleaning Logbook

• Cleaning Checklist

• Line Clearance Records (if applicable)

8.0 ABBREVIATIONS

• SOP: Standard Operating Procedure

• IPA: Isopropyl Alcohol

• PPE: Personal Protective Equipment

• GMP: Good Manufacturing Practice

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