Standard Operating Procedure for Cleaning of Equipment Used for Lotions

1) Purpose

The purpose of this SOP is to outline the procedure for cleaning equipment used in the manufacturing of lotions to prevent cross-contamination, ensure product quality, and maintain regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the cleaning and maintenance of equipment used for lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Production Operators:

• Perform cleaning of equipment according to this SOP after each batch of lotion production.
• Ensure proper disassembly and reassembly of equipment components for cleaning.

Quality Control Personnel:

• Verify that equipment cleaning procedures are followed and documented.
• Conduct visual inspections to ensure cleanliness of equipment.

Quality Assurance Personnel:

• Review and approve cleaning procedures and records.
• Ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Pre-Cleaning Preparation:

• Ensure all necessary cleaning materials, detergents, and tools are available and approved for use.
• Verify that equipment is properly labeled with batch information and cleaning status.

4.2 Cleaning Process:

1. Disassembly:
   • Follow the equipment manufacturer’s instructions for proper disassembly of parts.
   • Separate components that come into contact with the lotion product.
2. Pre-Cleaning:
   • Remove visible residues and debris from equipment surfaces using dry cleaning methods (e.g., brushing, scraping).
3. Washing:
   • Prepare cleaning solutions as per approved procedures and apply to equipment surfaces.
   • Use appropriate cleaning tools (e.g., brushes, sponges) to ensure thorough coverage and removal of residues.
4. Rinsing:
   • Rinse equipment thoroughly with purified water to remove cleaning agents and residues.
   • Ensure all cleaning solutions are completely removed from equipment surfaces.
5. Drying:
   • Air dry or use lint-free cloths to dry equipment components completely.
   • Ensure no moisture remains that could lead to contamination.
6. Reassembly:
   • Reassemble equipment components carefully, ensuring proper alignment and sealing.
   • Label equipment with clean status and batch information.

4.3 Inspection and Verification:

• Perform visual inspection of cleaned equipment to verify cleanliness.
• Document the cleaning process and inspection results in the equipment cleaning log or batch record.

4.4 Documentation:

• Record all cleaning activities, including cleaning agents used, time of cleaning, and personnel involved.
• Ensure all documentation is complete and accurate, including signatures of personnel performing and verifying the cleaning.

5) Abbreviations, if any

SOP: Standard Operating Procedure

USP: United States Pharmacopeia

6) Documents, if any

• Equipment Cleaning Log
• Batch Record
• Cleaning Validation Records

7) Reference, if any

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Equipment Cleaning and Cleaning Validation

8) SOP Version

Version 1.0