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