Standard Operating Procedure for Cleaning of Manufacturing Equipment
1) Purpose
The purpose of this SOP is to establish a standardized procedure for the cleaning of manufacturing equipment to prevent contamination and ensure product quality and safety.
2) Scope
This SOP applies to all manufacturing equipment used in the production process, including mixers, blenders, tanks, and filling machines within the facility.
3) Responsibilities
3.1 Cleaning Personnel
– Execute cleaning procedures as per this SOP.
– Record cleaning activities accurately.
3.2 Production Supervisor
– Ensure that cleaning procedures are followed.
– Verify and approve cleaning records.
3.3 Quality Assurance (QA) Personnel
– Review and approve cleaning procedures.
– Conduct periodic audits to ensure compliance.
4) Procedure
4.1 Preparation for Cleaning
4.1.1 Ensure the equipment is turned off and disconnected from power sources.
4.1.2 Remove all product residues and dispose of them properly.
4.2 Cleaning Agents
4.2.1 Select appropriate cleaning agents based on the equipment and residues.
4.2.2 Use validated cleaning agents to ensure effectiveness and compatibility.
4.3 Cleaning Process
4.3.1 Disassemble equipment parts that require individual cleaning.
4.3.2 Clean equipment using a combination of manual scrubbing and automated cleaning systems.
4.3.3 Rinse equipment thoroughly with potable water to remove cleaning agents.
4.4 Verification and Documentation
4.4.1 Inspect equipment to ensure cleanliness visually and through swab testing.
4.4.2 Record cleaning activities in the Cleaning Log, including date, time, personnel, and verification results.
4.5 Reassembly and Inspection
4.5.1 Reassemble equipment and ensure all parts are securely attached.
4.5.2 Conduct a final inspection to confirm that the equipment is clean and ready for use.
4.6 Cleaning Frequency
4.6.1 Establish cleaning frequency based on equipment usage, type of product, and regulatory requirements.
4.6.2 Perform routine cleaning after each production batch and deep cleaning at scheduled intervals.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Cleaning Log
– Equipment Cleaning Checklist
– Cleaning Agent Validation Records
7) Reference, if any
– FDA Guide to Inspections of Validation of Cleaning Processes
– ISO 14698-1: Cleanrooms and Associated Controlled Environments – Biocontamination Control
8) SOP Version
Version 1.0