volume, actuation force, spray weight, and spray pattern.

2. Scope

This SOP applies to Analytical Method Development (AMD) personnel responsible for method development and quality assessment of nasal spray pumps used in metered-dose delivery systems.

3. Responsibilities

• Analytical Scientist: Conducts testing of pump parameters and performs method optimization.
• QC Analyst: Assists with calibration, data recording, and validation of pump performance.
• QA Executive: Verifies data integrity, reviews validation report, and approves test method.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring pump performance methods are scientifically justified and meet regulatory and product quality expectations.

5. Procedure

5.1 Test Parameters

1. Delivered volume per actuation (µL)
2. Spray weight per actuation (mg)
3. Actuation force (N)
4. Spray pattern and plume geometry

5.2 Delivered Volume Test

1. Weigh empty collection vessel.
2. Actuate nasal spray pump into vessel (e.g., 10 actuations).
3. Weigh vessel again and calculate delivered volume using:
   
   Delivered Volume (µL) = (Final Weight − Initial Weight) / Number of Actuations × Density

5.3 Spray Weight Test

1. Weigh each spray actuation individually into tared collection tube using high-precision balance.
2. Perform for 10 doses and report average, min, max, and % RSD.

5.4 Actuation Force Measurement

1. Use force gauge (digital/manual) to press spray pump vertically.
2. Record peak force required to actuate (in Newtons).
3. Ensure pump is tested in three repetitions and under standard conditions (e.g., 23°C ±2°C).

5.5 Spray Pattern and Plume Geometry

1. Spray onto a clean paper placed 3 cm from nozzle.
2. Capture image using a high-resolution camera.
3. Use image analysis software to determine pattern symmetry and plume angle.

5.6 Acceptance Criteria

1. Delivered volume within ±15% of target label claim.
2. % RSD of spray weight ≤ 10% across 10 sprays.
3. Actuation force between 20–80 N depending on design specification.
4. Spray pattern should be symmetrical with defined plume angle (e.g., 30–60°).

5.7 Method Validation

1. Validate for repeatability, robustness (vary temperature/humidity), and intermediate precision.
2. Include pump-to-pump variability and replicate testing (minimum 3 units).

5.8 Documentation

1. Maintain test logs, balance calibration, force gauge calibration, and image data in Annexures.
2. Include detailed summary in Pump Test Validation Report.

6. Abbreviations

• RSD: Relative Standard Deviation
• HPLC: High Performance Liquid Chromatography
• AMD: Analytical Method Development

7. Documents

1. Spray Pump Test Log – Annexure-1
2. Force Gauge Calibration Certificate – Annexure-2
3. Pump Test Validation Report – Annexure-3

8. References

• FDA Guidance for Nasal Spray and Inhalation Drug Products
• USP <601>: Aerosols, Nasal Sprays, Metered-Dose Inhalers
• ICH Q2(R1): Validation of Analytical Procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Dr. Kavita Mehra	Ravi Suryavanshi	Sunita Reddy
Designation	Formulation Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Spray Pump Test Log

Sample ID	Delivered Volume (µL)	Actuation Force (N)	Spray Weight (mg)	RSD (%)
NSP-101	97.5	42	97.8	5.2

Annexure-2: Force Gauge Calibration Certificate

Gauge ID	Calibration Date	Calibrated By	Next Due Date
FG-005	01/05/2025	QCLab Services	01/05/2026

Annexure-3: Pump Test Validation Report

Nasal spray pump tested for delivered volume, spray weight, actuation force, and plume geometry. All test results were within specification with consistent reproducibility. Method approved for commercial batch evaluation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Included plume geometry and force gauge calibration steps	Annual SOP Review and Method Update	Sunita Reddy
10/04/2022	1.0	Initial SOP Release	New SOP	QA Head