Sterility Maintenance Procedures for MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for maintaining sterility during the production of metered-dose inhalers (MDIs) to prevent microbial contamination and ensure product safety and efficacy.
2) Scope
This SOP applies to all personnel involved in sterile manufacturing processes within the MDI production facility, including production operators, sterilization technicians, and quality assurance staff.
3) Responsibilities
The responsibilities for this SOP include implementing sterile practices, monitoring sterility conditions, conducting validations, and documenting sterilization activities. Specific roles include:
Production Operators: Follow sterile procedures during manufacturing activities.
Sterilization Technicians: Perform sterilization of equipment and components.
Quality Assurance Staff: Verify sterility procedures and conduct sterility testing as required.
4) Procedure
4.1 Facility Design and Maintenance
4.1.1 Design manufacturing areas to facilitate aseptic operations and minimize contamination risks.
4.1.2 Maintain cleanrooms and controlled environments according to specified cleanliness levels.
4.2 Personnel Practices
4.2.1 Train personnel on aseptic techniques and gowning procedures.
4.2.2 Ensure personnel adhere to hygiene practices and wear appropriate personal protective equipment (PPE).
4.3 Sterilization Procedures
4.3.1 Validate sterilization processes for equipment, components, and packaging materials.
4.3.2 Use validated sterilization methods (e.g., steam sterilization, gamma irradiation) as per approved procedures.
4.4 Environmental Monitoring
4.4.1 Perform environmental monitoring to assess and control microbial contamination levels.
4.4.2 Monitor air quality, surface bioburden, and personnel monitoring to ensure sterility.
4.5 Validation and Qualification
4.5.1 Validate sterilization processes and equipment according to regulatory requirements.
4.5.2 Qualify cleanrooms and sterilization equipment to ensure consistent sterility assurance.
4.6 Documentation and Records
4.6.1 Maintain records of sterilization validations, environmental monitoring results, and personnel training.
4.6.2 Document deviations, corrective actions, and preventive actions related to sterility maintenance.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Sterilization validation reports, environmental monitoring records, personnel training records, and SOPs for sterile manufacturing should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ISO 13408 for sterile manufacturing practices in pharmaceutical production.
8) SOP Version
Version 1.0
