are sterile and ready for use.

Record the equipment setup details in the equipment logbook.

4.1.2 Calibration of Analytical Instruments

• Calibrate all instruments used for measuring particle size and dosing uniformity. These may include laser diffraction analyzers and powder dosing machines.
• Document calibration results in the calibration log.

4.2 Material Preparation

4.2.1 Weighing and Blending

• Weigh the active pharmaceutical ingredients (APIs) and excipients (e.g., lactose, carriers) according to the batch manufacturing record (BMR).
• Mix the materials in a powder blender at the designated speed and duration, ensuring uniform distribution of the API and excipients.
• After blending, sieve the powder to ensure consistent particle size distribution, with a target size of 1-5 microns for nasal delivery.

4.2.2 Powder Homogeneity Testing

• Take samples from various points of the blend and test for uniformity using validated analytical methods (e.g., HPLC or UV spectrophotometry).
• Record the homogeneity results in the batch records.

4.3 Powder Filling in DPI Devices

4.3.1 Filling Process

• Transfer the blended powder into the DPI filling machine. Set the machine to the specified dosing quantity per inhaler (typically between 5-25 mg of powder per dose).
• Check dosing accuracy by testing 10 filled DPI units. Ensure the deviation is within ±5% of the target dose.

4.3.2 Device Assembly and Packaging

• After filling, assemble the DPI units by sealing the dosing chambers and attaching the DPI mouthpieces.
• Package the final products in sealed containers and label them with batch numbers, expiration dates, and dosage information.

4.4 Particle Size and Moisture Content Testing

4.4.1 Particle Size Analysis

• Measure the particle size distribution using a laser diffraction particle size analyzer. Ensure that the powder falls within the designated particle size range of 1-5 microns for nasal absorption.

4.4.2 Moisture Content Testing

• Test the moisture content of the powder using a moisture analyzer. Ensure that the moisture content is below 5% to prevent clumping and degradation of the powder.

4.5 Microbial and Endotoxin Testing

• Perform microbial testing on the final powder formulation to ensure sterility. Use standard procedures, such as plate counting or membrane filtration.
• Conduct endotoxin testing to ensure the formulation meets safety requirements.
• Document all microbial and endotoxin test results in the quality control log.

4.6 Stability Testing

• Conduct stability testing on the nasal powder to evaluate its shelf life and ensure it maintains the required potency, particle size, and moisture content over time.
• Place samples of the nasal powder in controlled environments with varying temperature and humidity conditions and test them at 1-month, 3-month, and 6-month intervals.
• Document all stability test results in the stability testing log.

5) Abbreviations, if any

• API: Active Pharmaceutical Ingredient
• DPI: Dry Powder Inhaler
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Particle Size Analysis Log
• Moisture Content Testing Log
• Microbial and Endotoxin Testing Records
• Stability Testing Log

7) References, if any

• FDA Guidance on Nasal Powder Formulations
• ICH Q8(R2) – Pharmaceutical Development Guidelines

8) SOP Version

Version 1.0

Annexure

Particle Size and Moisture Content Log Template

Date	Formulation	Particle Size (µm)	Moisture Content (%)	Operator Initials	QA Approval
DD/MM/YYYY	Formulation Name	Size	Moisture	Operator Name	QA Name