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