Standard Operating Procedure for Preventing Contamination in Aerosol Production
1) Purpose
The purpose of this SOP is to outline procedures for preventing contamination during aerosol production processes in the pharmaceutical industry. Contamination prevention is critical to ensure product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all stages of aerosol production at [Company Name], including formulation, filling, and packaging processes where contamination control measures are essential.
3) Responsibilities
Production Manager: Responsible for overseeing contamination prevention strategies.
Production Operators: Implement contamination control measures during production.
Quality Assurance (QA) Team: Conducts inspections and audits to ensure compliance.
4) Procedure
4.1 Facility Design and Layout:
4.1.1 Design production areas with separate zones for different stages of production (e.g., formulation, filling).
4.1.2 Implement unidirectional flow and positive pressure systems to minimize airborne contamination.
4.2 Personnel Training:
4.2.1 Provide training on contamination control practices, including gowning, hand hygiene, and aseptic techniques.
4.2.2 Conduct regular training sessions and assessments to reinforce proper procedures.
4.3 Environmental Monitoring:
4.3.1 Perform routine environmental monitoring of air quality and surface cleanliness in production areas.
4.3.2 Use microbial sampling and monitoring to identify potential sources of contamination.
4.4 Equipment Cleaning and Maintenance:
4.4.1 Establish and validate cleaning procedures for equipment used
4.4.2 Conduct preventive maintenance to ensure equipment integrity and reliability.
4.5 Material Handling and Storage:
4.5.1 Store raw materials and components in controlled environments with appropriate temperature and humidity conditions.
4.5.2 Use dedicated storage areas and bins to prevent cross-contamination between different materials.
4.6 Process Controls:
4.6.1 Implement process controls to minimize exposure of product to the environment during production.
4.6.2 Monitor critical process parameters to ensure consistency and reduce contamination risks.
4.7 Waste Management:
4.7.1 Segregate and dispose of waste materials properly to prevent contamination of production areas.
4.7.2 Implement procedures for handling hazardous waste and recyclable materials.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Environmental Monitoring Reports
Cleaning Validation Records
Training Attendance Logs
7) Reference, if any
GMP Guidelines
ISO 14644: Cleanrooms and associated controlled environments
8) SOP Version
Version 1.0