Standard Operating Procedure for Cleaning of Ointment Mill

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper cleaning of the ointment mill used in the formulation of cutaneous products. It aims to ensure that the mill is cleaned effectively to prevent cross-contamination between batches and maintain product quality and safety.

Scope

This SOP applies to all personnel involved in the cleaning and maintenance of the ointment mill used in the formulation, manufacturing, and processing of creams, ointments, and other cutaneous formulations.

Responsibilities

• Production Operators: Responsible for cleaning the ointment mill according to this SOP and ensuring that it is ready for the next batch.
• Quality Assurance (QA): Responsible for verifying the effectiveness of the cleaning process and conducting inspections to ensure compliance.
• Engineering Department: Responsible for maintenance and calibration of the ointment mill to ensure optimal performance.
• Supervisors: Responsible for overseeing the cleaning process and ensuring that all personnel adhere to safety protocols.

Procedure

1. Shutdown: Turn off the ointment mill and disconnect it from the power source to ensure safety during the cleaning process.
2. Disassembly: Disassemble the ointment mill according to the manufacturer’s instructions, removing all removable parts such as rollers and scraper blades.
3. Pre-Cleaning Inspection: Conduct a visual inspection of the mill to check for any residual product or contaminants that need to be removed.
4. Cleaning Solution Preparation: Prepare a cleaning solution using a suitable detergent or solvent recommended by the manufacturer.
5. Cleaning: Use brushes, cloths, or other cleaning tools to scrub all surfaces of the ointment mill, paying special attention to areas where product residue may accumulate.
6. Rinsing: Rinse all cleaned surfaces thoroughly with clean water to remove any remaining cleaning solution or loosened debris.
7. Sanitization: Apply a sanitizing agent to disinfect the ointment mill, ensuring that all surfaces are properly treated and allowed to air dry.
8. Reassembly: Once cleaned and sanitized, reassemble the ointment mill carefully, ensuring that all components are properly aligned and secured.
9. Post-Cleaning Inspection: Conduct a final inspection to verify that the ointment mill is clean, sanitized, and free from any visible residue or contaminants.
10. Documentation: Record all cleaning activities in the equipment logbook, including the date, time, cleaning agents used, and any deviations encountered.
11. Verification: QA shall verify the effectiveness of the cleaning process through visual inspection and may perform additional testing or sampling as required.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Equipment logbook
• Cleaning log
• Deviation reports

Reference

Refer to the manufacturer’s operation manual for the ointment mill and regulatory guidelines from authorities such as FDA, EMA, WHO, and ICH for specific requirements related to equipment cleaning in pharmaceutical manufacturing.

SOP Version

Version 1.0