Standard Operating Procedure for Cleaning and Sanitization of Equipment

1) Purpose

The purpose of this SOP is to ensure that all manufacturing equipment used in the production of dental dosage forms is properly cleaned and sanitized to prevent contamination and maintain product quality.

2) Scope

This SOP applies to all equipment used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Production Department is responsible for the cleaning and sanitization of equipment. The Quality Assurance (QA) Department is responsible for verifying and documenting the cleaning process.

4) Procedure

4.1 Preparation

4.1.1 Gather all necessary cleaning agents, sanitizers, and personal protective equipment (PPE).

4.1.2 Ensure the equipment is turned off and disconnected from power sources.

4.2 Cleaning

4.2.1 Disassemble the equipment as per the manufacturer’s instructions.

4.2.2 Remove any visible debris and residues using appropriate tools and cleaning agents.

4.2.3 Clean all equipment surfaces, including hard-to-reach areas, using designated cleaning agents.

4.3 Sanitization

4.3.1 Apply the approved sanitizer to all cleaned surfaces, following the manufacturer’s instructions.

4.3.2 Allow the sanitizer to remain on the surfaces for the required contact time.

4.3.3 Rinse the equipment thoroughly with purified water to remove any residual sanitizer.

4.4 Inspection and Documentation

4.4.1 Inspect the equipment visually to ensure it is clean and free of residues.

4.4.2 Document the cleaning and sanitization process in the equipment cleaning log.

4.4.3 Submit the cleaning log to the QA Department for review and approval.

5) Abbreviations, if any

PPE – Personal Protective Equipment

6) Documents, if any

Equipment Cleaning Log

Cleaning and Sanitization Protocol

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines

8) SOP Version

Version 1.0