Standard Operating Procedure for Equipment Cleaning Agents and Disinfectants
1) Purpose
The purpose of this SOP is to establish procedures for the selection, use, and management of cleaning agents and disinfectants used for cleaning and sanitizing equipment involved in the manufacturing of dental dosage forms, ensuring effective removal of contaminants and maintenance of hygienic conditions.
2) Scope
This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry, where proper cleaning and disinfection are critical to preventing contamination and ensuring product quality.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for approving cleaning agents and disinfectants. The Production Department is responsible for implementing cleaning procedures. The Engineering Department is responsible for maintaining cleaning equipment and tools. All personnel involved in cleaning and disinfection activities are responsible for following this SOP.
4) Procedure
4.1 Selection of Cleaning Agents and Disinfectants
4.1.1 Identify cleaning agents and disinfectants suitable for use on specific equipment based on material compatibility, efficacy, and regulatory requirements.
4.1.2 Obtain QA approval for all cleaning agents and disinfectants before use, ensuring they meet established quality and safety standards.
4.2 Preparation of Cleaning Solutions
4.2.1 Follow manufacturer’s instructions and approved procedures to prepare
4.2.2 Label prepared cleaning solutions with relevant information, including name, concentration, date of preparation, and expiry date.
4.3 Cleaning Procedures
4.3.1 Disassemble equipment parts as required and remove gross contaminants before applying cleaning solutions.
4.3.2 Apply cleaning solutions to equipment surfaces using approved methods, such as spraying, wiping, or soaking, ensuring thorough coverage.
4.3.3 Allow the cleaning solution to contact surfaces for the recommended duration to achieve effective cleaning.
4.3.4 Rinse equipment surfaces with purified water to remove residual cleaning agents, ensuring complete removal.
4.4 Disinfection Procedures
4.4.1 Apply approved disinfectants to cleaned equipment surfaces using appropriate methods, ensuring even distribution and contact with all surfaces.
4.4.2 Allow the disinfectant to remain on surfaces for the specified contact time to achieve effective disinfection.
4.4.3 Rinse equipment surfaces with purified water if required by the disinfectant manufacturer’s instructions, ensuring removal of residual disinfectants.
4.5 Documentation and Record-Keeping
4.5.1 Maintain detailed records of cleaning and disinfection activities, including the cleaning agent and disinfectant used, concentration, contact time, and personnel involved.
4.5.2 Document any deviations from established procedures and corrective actions taken to address them.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Approved List of Cleaning Agents and Disinfectants
Cleaning and Disinfection Records
Equipment Cleaning Logs
7) Reference, if any
Manufacturer’s instructions for cleaning agents and disinfectants
Regulatory guidelines for equipment cleaning and disinfection
8) SOP Version
Version 1.0