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