in drug delivery, device performance, and regulatory compliance.

2. Scope

This SOP applies to the Analytical Method Development (AMD) department for conducting spray characterization studies of plume geometry using image analysis systems during product development and batch release.

3. Responsibilities

• Analytical Scientist: Conducts image capture and analysis of the spray plume.
• QC Analyst: Assists with sample setup, lighting control, and data recording.
• QA Executive: Reviews image data, analysis reports, and validates method performance.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that the plume geometry analysis is performed accurately, reproducibly, and in alignment with regulatory expectations.

5. Procedure

5.1 Equipment and Setup

1. High-resolution digital camera with laser alignment system.
2. Dark background board and controlled lighting source.
3. Metered-dose spray actuator fixture (with vertical clamp and trigger mechanism).
4. Image analysis software capable of measuring angles and geometric dimensions.

5.2 Sample Preparation

1. Select 3–6 units of the product from the batch.
2. Shake the unit as per label claim before each actuation.
3. Prime the device if required (3–5 actuations).

5.3 Spray Capture Procedure

1. Place the device 3–5 cm from the background.
2. Actuate device in a darkened room with controlled light source perpendicular to spray path.
3. Capture the spray image at the apex of spray burst (within 100–150 ms).
4. Repeat for three replicate sprays from each unit.

5.4 Image Analysis

1. Analyze each image using validated software.
2. Record:
   • Spray angle (degrees)
   • Plume width (cm)
   • Plume symmetry (difference between left and right halves)
3. Document any anomalies such as tailing, streaking, or satellite plumes.

5.5 Acceptance Criteria

1. Spray angle should be within 30°–60° depending on formulation type.
2. Plume symmetry deviation should be ≤10% between left and right side.
3. Consistent reproducibility across replicate sprays (RSD ≤ 10%).

5.6 Method Validation

1. Validate method for:
   • Repeatability (same device)
   • Reproducibility (multiple devices)
   • Robustness (light variation, camera angle tolerance)

5.7 Documentation

1. Include raw image files, annotated analysis images, and angle measurements in the report.
2. Summarize findings in plume geometry analysis report and retain as part of batch record.

6. Abbreviations

• MDI: Metered Dose Inhaler
• RSD: Relative Standard Deviation
• QA: Quality Assurance

7. Documents

1. Plume Geometry Test Log – Annexure-1
2. Image Capture Checklist – Annexure-2
3. Plume Geometry Validation Report – Annexure-3

8. References

• FDA Guidance for Industry: Nasal Spray and Inhalation Solution Product Quality
• 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	Manasi Patil	Vivek Anand	Sunita Reddy
Designation	Analytical Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Plume Geometry Test Log

Device ID	Spray Angle (°)	Plume Width (cm)	Symmetry (%)	Status
NS-245-01	47	3.8	5%	Pass

Annexure-2: Image Capture Checklist

Parameter	Checked (Yes/No)	Remarks
Camera Focus	Yes	Auto-mode enabled
Lighting Angle	Yes	Side illumination used
Spray Distance	Yes	Fixed at 3.5 cm

Annexure-3: Plume Geometry Validation Report

Plume geometry analysis method was validated for nasal spray NS-245 using laser-aligned camera system. All devices produced consistent spray angles within 45°–50°, with symmetrical plume distribution. Method approved for commercial product evaluation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Expanded test parameters, added symmetry analysis and checklist	Annual Review and Regulatory Alignment	Sunita Reddy
05/04/2022	1.0	Initial SOP Release	New SOP	QA Head