Procedure for Nasal Spray Pump Performance Testing

1) Purpose

The purpose of this SOP is to outline the procedure for testing the performance of nasal spray pumps used for administering pharmaceutical products to ensure proper functionality and dosage accuracy.

2) Scope

This SOP applies to all nasal spray pumps used for administering pharmaceutical products, requiring testing to comply with regulatory requirements and internal specifications regarding pump performance.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing nasal spray pump performance testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing nasal spray pumps and support during testing.

4) Procedure

4.1 Sample Selection:
    4.1.1 Select representative nasal spray pumps from current production batches.
    4.1.2 Ensure samples include different pump sizes and configurations.

4.2 Priming and Calibration:
    4.2.1 Prime the nasal spray pump according to manufacturer’s instructions.
    4.2.2 Calibrate the pump to ensure consistent spray volume and dosage delivery.

4.3 Spray Performance Testing:
    4.3.1 Perform spray pattern and plume geometry testing to evaluate spray distribution and coverage.
    4.3.2 Use calibrated equipment to measure spray angle, droplet size distribution, and spray pattern uniformity.

4.4 Dose Accuracy Verification:
    4.4.1 Measure the delivered dose per actuation using a validated method (e.g., gravimetric method, dose content uniformity testing).
    4.4.2 Compare delivered doses against intended doses and acceptance criteria.

4.5 Functional Testing:
    4.5.1 Evaluate pump functionality under different environmental conditions (e.g., temperature, humidity).
    4.5.2 Test pump performance after repeated actuations to assess durability and reliability.

4.6 Compatibility Testing:
    4.6.1 Verify compatibility of nasal spray pump materials with pharmaceutical products to prevent interaction or degradation.
    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 accuracy verification, 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 Nasal Spray Pump 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

Nasal Spray Pump Performance Testing Report
Performance Test Records
Dose Accuracy Verification Data

7) Reference, if any

ISO 13485:2016 – Medical devices – Quality management systems
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics

8) SOP Version

Version 1.0