Procedure for Metered Dose Inhaler (MDI) Performance Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the performance of metered dose inhalers (MDIs) used for administering pharmaceutical products to ensure proper functionality and dose accuracy.
2) Scope
This SOP applies to all MDIs used for administering pharmaceutical products, requiring testing to comply with regulatory requirements and internal specifications regarding inhaler performance.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing MDI performance testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing MDIs and support during testing.
4) Procedure
4.1 Sample Selection:
4.1.1 Select representative MDIs from current production batches.
4.1.2 Ensure samples include different inhaler types and configurations.
4.2 Priming and Calibration:
4.2.1 Prime the MDI according to manufacturer’s instructions.
4.2.2 Calibrate the MDI to ensure consistent dose delivery and spray pattern.
4.3 Spray Performance Testing:
4.3.1 Perform actuation tests to measure delivered dose per actuation using a validated method (e.g., gravimetric method).
4.3.2 Evaluate spray pattern and particle size distribution using calibrated equipment.
4.4 Dose Uniformity Testing:
4.4.1 Conduct dose content uniformity testing to verify uniformity of drug content across multiple actuations.
4.4.2 Compare test results against acceptance criteria and regulatory standards.
4.5 Functional Testing:
4.5.1 Assess MDI functionality under various conditions (e.g., after priming, at different storage temperatures).
4.5.2 Test MDI performance after repeated actuations to evaluate durability and reliability.
4.6 Compatibility Testing:
4.6.1 Verify compatibility of MDI materials with pharmaceutical products to ensure stability and efficacy.
4.6.2 Perform testing under simulated storage conditions (e.g., stability chambers).
4.7 Data Analysis:
4.7.1 Compile and analyze test data, including spray performance results, dose uniformity testing outcomes, functional testing results, and compatibility assessments.
4.7.2 Review data against acceptance criteria and regulatory standards.
4.8 Reporting:
4.8.1 Prepare an MDI Performance Testing Report summarizing test procedures, results, and conclusions.
4.8.2 Include recommendations for improvements or corrective actions based on test findings.
4.8.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
MDI Performance Testing Report
Performance Test Records
Dose Uniformity Testing Data
7) Reference, if any
ISO 20072:2020 – Aerosol drug delivery device design and evaluation
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0