Procedure for Dry Powder Inhaler (DPI) Performance Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the performance of dry powder inhalers (DPIs) used for administering pharmaceutical products to ensure proper functionality and dose accuracy.
2) Scope
This SOP applies to all DPIs 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 DPI performance testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing DPIs and support during testing.
4) Procedure
4.1 Sample Selection:
4.1.1 Select representative DPIs from current production batches.
4.1.2 Ensure samples include different inhaler types and configurations.
4.2 Calibration:
4.2.1 Calibrate the DPI according to manufacturer’s instructions to ensure accurate dose delivery and dispersion.
4.2.2 Verify proper assembly and functionality of the DPI device.
4.3 Dose Uniformity Testing:
4.3.1 Conduct dose uniformity testing to evaluate the consistency of drug content across multiple doses.
4.3.2 Use a validated method (e.g., weight variation method) to assess uniformity.
4.4 Fine Particle Fraction Testing:
4.4.1 Measure the fine particle fraction using an appropriate cascade impactor to assess the proportion of drug particles capable of reaching the lungs.
4.4.2 Analyze the collected particles to determine the percentage of particles within specified size ranges.
4.5 Functional Testing:
4.5.1 Evaluate DPI functionality by assessing powder dispersion and dose delivery consistency.
4.5.2 Perform functional tests under various airflow rates to simulate patient inhalation conditions.
4.6 Compatibility Testing:
4.6.1 Verify compatibility of DPI 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 dose uniformity results, fine particle fraction data, functional testing outcomes, and compatibility assessments.
4.7.2 Review data against acceptance criteria and regulatory standards.
4.8 Reporting:
4.8.1 Prepare a DPI 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
DPI 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
