Standard Operating Procedure for Cleaning and Sanitization of Equipment and Facilities in Cutaneous Formulation

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the cleaning and sanitization of equipment and facilities used in the formulation of cutaneous products. It aims to ensure that all equipment and facilities are maintained in a clean and sanitary condition to prevent contamination and ensure product quality and safety.

Scope

This SOP applies to all personnel involved in the cleaning and sanitization of equipment and facilities used in the formulation, manufacturing, testing, and packaging of cutaneous formulations.

Responsibilities

• Production Operators: Responsible for performing routine cleaning and sanitization of equipment and facilities as per the established procedures.
• Cleaning Crew: Responsible for executing detailed cleaning and sanitization activities, including disassembly and reassembly of equipment as required.
• Quality Assurance (QA): Responsible for verifying the effectiveness of cleaning and sanitization activities through inspections, swab testing, and documentation review.
• Facility Management: Responsible for providing necessary resources and support to ensure compliance with cleaning and sanitization procedures.

Procedure

1. Preparation: Ensure that all equipment and facilities requiring cleaning and sanitization are properly identified and isolated from production areas.
2. Dismantling: Disassemble equipment as per manufacturer’s instructions, ensuring proper labeling and segregation of removable parts.
3. Cleaning: Use appropriate cleaning agents and detergents to thoroughly clean equipment surfaces, including hard-to-reach areas and crevices.
4. Sanitization: Apply approved sanitizing agents to disinfect equipment surfaces and prevent microbial contamination.
5. Rinsing: Rinse equipment and facilities with clean water to remove any residual cleaning and sanitizing agents.
6. Drying: Allow equipment and facilities to air dry or use clean, lint-free cloths to dry surfaces thoroughly.
7. Reassembly: Reassemble equipment and facilities in accordance with manufacturer’s instructions, ensuring proper alignment and tightness of fittings.
8. Inspection: Conduct visual inspections to verify that equipment and facilities are clean, sanitized, and free from any visible residues or contaminants.
9. Documentation: Document all cleaning and sanitization activities, including date, time, personnel involved, cleaning agents used, and any deviations or observations.
10. Verification: QA shall verify the effectiveness of cleaning and sanitization through periodic swab testing and microbial monitoring.
11. Training: Provide training to personnel on proper cleaning and sanitization procedures, including safety precautions and handling of cleaning agents.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Cleaning and sanitization logbook
• Swab testing records
• Training records
• Deviation reports

Reference

Refer to regulatory guidelines from authorities such as FDA, EMA, WHO, and ICH for specific requirements related to cleaning and sanitization of equipment and facilities in pharmaceutical manufacturing.

SOP Version

Version 1.0