Contamination Prevention Procedures for MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for preventing contamination during the production of metered-dose inhalers (MDIs) to ensure product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in MDI production processes, including production operators, maintenance technicians, quality control personnel, and cleaning staff.
3) Responsibilities
The responsibilities for this SOP include implementing contamination control measures, monitoring cleanliness levels, conducting inspections, and documenting contamination prevention activities. Specific roles include:
Production Operators: Follow contamination control procedures during production activities.
Maintenance Technicians: Maintain equipment to prevent contamination risks.
Quality Control Personnel: Monitor cleanliness and perform inspections to identify contamination sources.
Cleaning Staff: Clean production areas and equipment according to approved procedures.
4) Procedure
4.1 Facility Design and Layout
4.1.1 Design manufacturing areas to minimize contamination risks and facilitate cleaning.
4.1.2 Implement controlled access and segregation of clean and dirty areas.
4.2 Cleaning and Disinfection
4.2.1 Develop and implement cleaning procedures for equipment, surfaces, and production areas.
4.2.2 Use validated cleaning agents and methods to remove contaminants effectively.
4.3 Material Handling and
4.3.1 Store raw materials, components, and finished products in designated areas with appropriate controls.
4.3.2 Implement FIFO (First In, First Out) principles to minimize storage time and risks of contamination.
4.4 Personnel Hygiene and Gowning
4.4.1 Train personnel on hygiene practices, gowning requirements, and use of personal protective equipment (PPE).
4.4.2 Monitor personnel adherence to hygiene practices and conduct regular gowning inspections.
4.5 Environmental Monitoring
4.5.1 Perform environmental monitoring to assess cleanliness levels and microbial contamination.
4.5.2 Monitor air quality, surface bioburden, and personnel monitoring to prevent contamination.
4.6 Inspections and Audits
4.6.1 Conduct routine inspections and audits of production areas, equipment, and processes.
4.6.2 Document inspection findings, deviations, and corrective actions taken.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
FIFO: First In, First Out
6) Documents, if any
Cleaning validation reports, environmental monitoring records, personnel training records, and SOPs for contamination control should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ISO 14644 for contamination control in pharmaceutical manufacturing.
8) SOP Version
Version 1.0