Standard Operating Procedure for Operation of Vacuum Emulsifying Mixer
Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and efficient operation of the vacuum emulsifying mixer used in the formulation of cutaneous products. It aims to ensure that the equipment is operated correctly, minimizing the risk of product contamination and ensuring consistent product quality.
Scope
This SOP applies to all personnel involved in the operation of the vacuum emulsifying mixer in the formulation, manufacturing, and processing of creams, ointments, gels, powders, and pastes applied topically to the skin.
Responsibilities
- Production Operators: Responsible for operating the vacuum emulsifying mixer in accordance with this SOP and manufacturer’s instructions.
- Quality Assurance (QA): Responsible for verifying the proper operation of the vacuum emulsifying mixer and conducting in-process checks to ensure product quality.
- Engineering Department: Responsible for maintenance and calibration of the vacuum emulsifying mixer to ensure optimal performance.
- Supervisors: Responsible for overseeing the operation of the equipment and ensuring compliance with safety protocols.
Procedure
- Preparation: Ensure that the vacuum emulsifying mixer is clean, sanitized, and free from any residual product or contaminants.
- Setup: Set up the equipment according to the formulation requirements, including adjusting speed settings, temperature controls, and vacuum levels.
- Ingredient Addition: Gradually add the required ingredients into the
Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
Documents
- Batch record
- Equipment logbook
- Cleaning log
- Deviation reports
Reference
Refer to the manufacturer’s operation manual for the vacuum emulsifying mixer and regulatory guidelines from authorities such as FDA, EMA, WHO, and ICH for specific requirements related to equipment operation in pharmaceutical manufacturing.
SOP Version
Version 1.0