Standard Operating Procedure (SOP)

1.0 OBJECTIVE

To establish a procedure for cleaning stainless steel vessels and utensils to ensure hygiene, prevent contamination, and comply with GMP (Good Manufacturing Practices).

2.0 SCOPE

This SOP applies to all stainless steel vessels, containers, mixing vessels, and utensils used in the production area at [Company Name].

3.0 RESPONSIBILITY

• Production Operators: Responsible for performing the cleaning procedure as per the SOP.

• Production Supervisor: To oversee the proper execution of the SOP.

• Quality Assurance (QA): To verify and validate the cleaning procedure and maintain records.

4.0 MATERIALS AND EQUIPMENT REQUIRED

• Lint-free cloths

• Nylon scrub brushes

• Clean potable water

• Cleaning detergent (non-abrasive and suitable for stainless steel)

• 70% Isopropyl Alcohol (IPA) or Sanitizer (if required)

• PPE (Personal Protective Equipment): gloves, mask, gown, goggles

• Cleaning tags (Cleaned/To Be Cleaned)

• Drying rack or clean drying area

• Cleaning logbook

5.0 PROCEDURE

5.1 Pre-Cleaning Preparation

1. Ensure all equipment is turned off and disconnected from the power supply (if applicable).

2. Remove any leftover material from the vessel and utensils.

3. Wear appropriate PPE (gloves, gown, mask, goggles).

4. Tag the equipment as “To Be Cleaned” using the designated tags.

5.2 Dry Cleaning

1. Dry Brush:

   • Use a dry lint-free cloth or nylon brush to remove powder residues or solid product remnants from the surface.

   • Ensure that all internal surfaces (e.g., base, sides) are thoroughly cleaned.

5.3 Wet Cleaning

1. Preparation of Cleaning Solution:

   • Prepare a solution of approved detergent and water (following manufacturer’s guidelines) for washing the vessel and utensils.

   • Ensure that the detergent is suitable for stainless steel to avoid corrosion.

2. Washing:

   • Immerse the vessel and utensils in the cleaning solution or use a damp cloth to wipe all surfaces, including internal and external parts.

   • Scrub the internal surfaces with a soft nylon brush to remove any stubborn residues.

3. Rinsing:

   • Rinse thoroughly with clean potable water to remove all detergent residues.

   • Ensure that no detergent or cleaning solution remains on the surfaces.

5.4 Sanitization (if applicable)

1. Sanitization:

   • Wipe the internal and external surfaces with 70% IPA or a suitable sanitizer, depending on the specific requirements for the process.

   • Allow the sanitized vessel and utensils to air dry. If required, use a clean, lint-free cloth to wipe off any excess sanitizer.

5.5 Drying

1. Drying:

   • Dry the cleaned vessel and utensils using a clean, dry cloth or place them in a clean drying area to air dry.

   • Ensure that no residual moisture remains, especially in hard-to-reach areas.

5.6 Post-Cleaning Inspection

1. Inspection:

   • Visually inspect the cleaned vessel and utensils for cleanliness. Check for any remaining residues, stains, or spots.

   • Ensure that no detergent or sanitizer residues are present.

2. Reassembly and Labeling:

   • Reassemble any removable parts (e.g., lids, covers) after ensuring that all components are clean and dry.

   • Affix a “Cleaned” label with the date, time, and operator’s initials to the equipment.

3. Cleaning Record:

   • Record the cleaning activity in the cleaning logbook, noting any issues or concerns identified during the process.

6.0 CLEANING FREQUENCY

• After every use or batch process

• At regular intervals, as per cleaning validation protocol

• After product changeovers

• After maintenance or repair

7.0 RECORDS AND DOCUMENTATION

• Cleaning Logbook

• Equipment Cleaning Checklist

• Inspection Reports

• 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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