capture and image processing techniques, ensuring reproducibility and conformance to design specifications.

2. Scope

This SOP applies to all nasal and inhalation products tested by the Analytical Method Development (AMD) team during method development, device validation, and stability studies.

3. Responsibilities

• Analytical Scientist: Responsible for method setup, execution, data acquisition, and interpretation.
• QC Analyst: Assists with sample handling, equipment preparation, and records management.
• QA Executive: Reviews and approves plume geometry validation and testing records.

4. Accountability

The Head of Analytical Method Development is accountable for the scientific integrity, reproducibility, and regulatory compliance of plume geometry testing.

5. Procedure

5.1 Equipment Setup

1. Use a high-speed digital camera with frame rate ≥ 1000 fps.
2. Set up a vertical clamping system for consistent spray orientation.
3. Background: Use matte black screen with alignment grid.
4. Lighting: Use diffused white light from both sides to eliminate shadows and glare.

5.2 Sample Preparation

1. Select 3 units from the production or development batch.
2. Shake each device for 10 seconds before testing.
3. Prime each unit with 3 actuations into waste container.

5.3 Image Capture and Plume Visualization

1. Position nozzle 3 cm from the camera.
2. Actuate spray and capture high-speed video of plume for 1 second.
3. Save video frames for image analysis using validated software.

5.4 Image Analysis and Parameter Measurement

1. Use image analysis software to determine:
   • Plume angle: Measured between outer edges of spray
   • Spray width: Lateral spread at defined distance (typically 3 cm)
   • Symmetry: Comparison of left and right halves of the plume
   • Shape: Conical or oval categorization

5.5 Acceptance Criteria

1. Plume angle: Typically between 30° to 70° (depending on device specification).
2. Symmetry index: ≥ 0.85 (ratio of symmetrical plume halves).
3. Shape: Should resemble a uniform cone or consistent oval shape.

5.6 Method Validation

1. Repeatability: Triplicate sprays from each of 3 units; calculate % RSD for plume angle (≤ 10%).
2. Robustness: Evaluate effect of ambient conditions (e.g., 15–30°C).
3. Intermediate precision: Test performed by two analysts on separate days.

5.7 Documentation

1. Maintain original images, angle measurements, analyst comments, and raw data sheets.
2. Attach the validated image report to batch release documents or development files.

6. Abbreviations

• MDI: Metered Dose Inhaler
• RSD: Relative Standard Deviation
• QA: Quality Assurance
• AMD: Analytical Method Development

7. Documents

1. Plume Geometry Data Log – Annexure-1
2. Image Capture Log Sheet – Annexure-2
3. Plume Geometry Validation Report – Annexure-3

8. References

• FDA Guidance: Nasal Spray and Inhalation Product Testing
• USP <601>: Aerosols, Nasal Sprays, and MDIs
• 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	Tanvi Bhatt	Kunal Joshi	Sunita Reddy
Designation	Analytical Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Plume Geometry Data Log

Device ID	Plume Angle (°)	Spray Width (cm)	Symmetry Index	Shape	Status
NSP-001	52	3.8	0.91	Conical	Pass

Annexure-2: Image Capture Log Sheet

Date	Camera ID	Tested By	Image Ref. No.	Ambient Temp (°C)
20/05/2025	CAM-HD-04	Tanvi Bhatt	IMG-PG-20250520-01	24.3

Annexure-3: Plume Geometry Validation Report

Method for plume geometry analysis validated for nasal spray NSP-25. Spray angle average: 52°, symmetry index 0.91, % RSD for triplicates: 3.8%. Method acceptable for routine testing and regulatory filing.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Added symmetry index and image processing tool criteria	Annual Review and Validation Enhancement	Sunita Reddy
05/04/2022	1.0	Initial Release	New SOP	QA Head