Standard Operating Procedure for Maintaining Sterility in Aerosol Production
1) Purpose
The purpose of this SOP is to establish procedures for maintaining sterility during aerosol production processes in the pharmaceutical industry. This ensures that aerosol products are free from microbial contamination, meeting regulatory requirements and quality standards.
2) Scope
This SOP applies to all stages of aerosol production at [Company Name], including formulation, filling, and packaging processes requiring a sterile environment.
3) Responsibilities
Quality Assurance (QA) Manager: Oversees implementation of sterility maintenance procedures.
Production Operators: Responsible for adhering to sterile practices during production.
Microbiology Laboratory: Conducts environmental monitoring and sterility testing.
4) Procedure
4.1 Cleanroom Classification:
4.1.1 Classify production areas according to cleanliness levels based on ISO standards (e.g., ISO 5, ISO 7).
4.1.2 Maintain cleanroom conditions through appropriate HVAC systems and air filtration.
4.2 Personnel Hygiene:
4.2.1 Implement gowning procedures for personnel entering sterile areas, including use of sterile gowns, gloves, and hair covers.
4.2.2 Train personnel on proper hand hygiene and aseptic techniques before entering production areas.
4.3 Environmental Monitoring:
4.3.1 Conduct routine environmental monitoring of air quality and surface cleanliness in production areas.
4.3.2 Perform microbial monitoring through viable air and surface sampling.
4.4 Equipment Sterilization:
4.4.1 Validate and maintain sterilization procedures for equipment used in sterile production processes.
4.4.2 Use validated sterilization methods such as autoclaving, gamma irradiation, or chemical sterilization.
4.5 Material Transfer:
4.5.1 Use sterile transfer methods and closed systems for transferring materials into sterile production areas.
4.5.2 Minimize open handling of components and ensure aseptic connections during material transfer.
4.6 Process Validation:
4.6.1 Validate sterile production processes through media fills or simulation tests.
4.6.2 Monitor and record process parameters during production to ensure sterility assurance.
4.7 Cleaning and Disinfection:
4.7.1 Implement validated cleaning and disinfection procedures for equipment and surfaces in sterile areas.
4.7.2 Use disinfectants with proven efficacy against microbial contaminants.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
HVAC: Heating, Ventilation, and Air Conditioning
6) Documents, if any
Environmental Monitoring Records
Sterilization Validation Reports
Cleaning and Disinfection Logs
7) Reference, if any
ISO 14644: Cleanrooms and associated controlled environments
USP <1231>: Sterilization and Sterility Assurance of Compendial Articles
8) SOP Version
Version 1.0