Standard Operating Procedure for Mouthwash Manufacturing Equipment
1) Purpose
The purpose of this SOP is to provide guidelines for the operation and maintenance of equipment used in the manufacturing of dental mouthwashes to ensure consistent product quality and compliance with regulatory standards.
2) Scope
This SOP applies to all equipment used in the manufacturing process of dental mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for operating and cleaning the mouthwash manufacturing equipment. The Quality Assurance (QA) Department is responsible for verifying and documenting compliance with this SOP.
4) Procedure
4.1 Preparation
4.1.1 Verify that the equipment is clean and in good working condition before use.
4.1.2 Ensure all raw materials are weighed and prepared according to the batch record.
4.2 Mixing and Heating
4.2.1 Set up the mixing equipment and heating apparatus as per the manufacturer’s instructions and batch record requirements.
4.2.2 Add raw materials into the mixing vessel in the specified order and quantities.
4.2.3 Start the equipment and heat the mixture to the specified temperature as per the batch record.
4.2.4 Monitor the mixing and heating process to dissolve all ingredients and achieve uniformity.
4.2.5 Record the start time, end time, and any observations during the mixing process in the batch record.
4.3 Cooling and Addition
4.3.1 After mixing, cool the mouthwash mixture to the specified temperature for the addition of excipients.
4.3.2 Add excipients (e.g., flavors, preservatives) into the mixture as per the batch record.
4.3.3 Mix thoroughly to ensure uniform distribution of excipients in the mouthwash.
4.4 Filling
4.4.1 Transfer the mixed mouthwash to the filling machine according to batch record specifications.
4.4.2 Operate the filling machine to fill containers with the mouthwash, ensuring accurate volume.
4.4.3 Label filled containers with product information and batch details.
4.5 Cleaning
4.5.1 After use, turn off the equipment and disconnect it from the power source.
4.5.2 Disassemble parts of the equipment and clean all contact surfaces using approved cleaning agents.
4.5.3 Rinse thoroughly with purified water to remove any residual cleaning agents.
4.5.4 Inspect the equipment for cleanliness and reassemble it after it is completely dry.
4.6 Maintenance
4.6.1 Perform regular preventive maintenance on the equipment as per the manufacturer’s guidelines.
4.6.2 Record all maintenance activities in the equipment maintenance log.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
Batch Record
Equipment Maintenance Log
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0