Propellant Testing Procedures in MDIs
1) Purpose
The purpose of this SOP is to establish procedures for the testing of propellants used in metered-dose inhalers (MDIs) to ensure their quality, safety, and compatibility with product formulations.
2) Scope
This SOP applies to all personnel involved in propellant testing activities within the MDI production facility, including analytical chemists, quality control technicians, and production supervisors.
3) Responsibilities
The responsibilities for this SOP include conducting propellant testing, interpreting test results, documenting findings, and ensuring compliance with specifications. Specific roles include:
Analytical Chemists: Perform analytical testing of propellants using validated methods.
Quality Control Technicians: Verify propellant quality and ensure compatibility with MDI formulations.
Production Supervisors: Review testing outcomes and authorize propellant use based on test results.
4) Procedure
4.1 Sample Preparation
4.1.1 Collect representative samples of propellants used in MDIs.
4.1.2 Ensure samples are handled and stored under controlled conditions to maintain integrity.
4.2 Testing Methods
4.2.1 Use validated analytical methods (e.g., gas chromatography) to analyze propellant composition and purity.
4.2.2 Perform testing according to established protocols and acceptance criteria.
4.3 Compatibility Testing
4.3.1 Evaluate propellant compatibility
4.3.2 Document test results and assess any interactions or adverse effects observed.
4.4 Documentation
4.4.1 Record propellant testing procedures, including sample collection methods and analytical techniques used.
4.4.2 Document testing results, deviations observed, and any corrective actions taken.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Propellant testing protocols, test records, analytical method validations, and batch release certificates should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for propellant testing requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
