Standard Operating Procedure for Cleaning and Sanitization of Filling Machines
1) Purpose
The purpose of this SOP is to provide guidelines for the cleaning and sanitization of filling machines used in the manufacturing of dental dosage forms to prevent cross-contamination and ensure product quality and safety.
2) Scope
This SOP applies to all filling machines used in the manufacturing process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for cleaning and sanitizing the filling machines. The Quality Assurance (QA) Department is responsible for verifying and documenting compliance with this SOP.
4) Procedure
4.1 Preparation
4.1.1 Ensure that all product has been removed from the filling machine.
4.1.2 Gather all necessary cleaning and sanitization materials and equipment.
4.2 Cleaning Process
4.2.1 Wear appropriate personal protective equipment (PPE) before starting the cleaning process.
4.2.2 Disassemble the filling machine as per manufacturer’s guidelines.
4.2.3 Clean all removable parts and contact surfaces using approved cleaning agents.
4.2.4 Scrub equipment surfaces thoroughly to remove any residue or product build-up.
4.2.5 Rinse all cleaned surfaces with purified water to remove cleaning agents.
4.3 Sanitization Process
4.3.1 Prepare sanitizing solution as per approved procedure.
4.3.2 Apply sanitizing solution to all cleaned surfaces of the filling machine.
4.3.3 Ensure complete coverage of all surfaces and allow the sanitizing solution to remain for the specified contact time.
4.3.4 Rinse equipment thoroughly with purified water after sanitization.
4.4 Drying and Reassembly
4.4.1 Allow equipment to air dry in a designated clean area or use lint-free cloths for drying.
4.4.2 Reassemble filling machine once completely dry, ensuring all parts are properly aligned and secured.
4.5 Inspection and Verification
4.5.1 Inspect the cleaned and sanitized filling machine for cleanliness and integrity.
4.5.2 Perform verification checks to ensure all cleaning and sanitization procedures have been properly executed.
4.6 Documentation
4.6.1 Record all cleaning and sanitization activities in the equipment cleaning log.
5) Abbreviations, if any
PPE – Personal Protective Equipment
6) Documents, if any
Equipment Cleaning Log
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
