Standard Operating Procedure for Maintenance and Calibration of Particle Size Analyzers
1) Purpose
This SOP outlines the procedures for maintaining and calibrating particle size analyzers to ensure accurate measurement of nasal spray powders or suspensions.
2) Scope
This SOP applies to all personnel involved in the maintenance and calibration of particle size analyzers used in quality control for nasal formulations at [Company Name].
3) Responsibilities
- Operators: Responsible for using the particle size analyzer and performing routine cleaning after each use.
- Quality Assurance (QA): Ensures that the particle size distribution results are within specified limits for each formulation.
- Maintenance Team: Responsible for performing regular maintenance and calibration of the particle size analyzers.
4) Procedure
4.1 Calibration of Particle Size Analyzers
4.1.1 Pre-Calibration Inspection
- Inspect the particle size analyzer for any signs of damage or malfunction. Ensure that the laser source (if applicable) and sample dispersion units are clean and functioning.
- Document the inspection in the equipment log before starting calibration.
4.1.2 Calibration Procedure
- Use certified reference materials with known particle sizes to calibrate the analyzer. Load the reference material into the analyzer following the manufacturer’s instructions.
- Run the calibration test and compare the measured particle size distribution with the certified values. If the measured values deviate from the certified values, recalibrate the system until it meets the required accuracy.
- Record the calibration results in the calibration log.
4.2 Maintenance of Particle Size Analyzers
4.2.1 Routine Cleaning
- After each use, disassemble any removable parts of the analyzer, such as sample dispersion units or laser lenses, and clean them using an approved cleaning solution.
- Rinse thoroughly with sterile water and dry with lint-free wipes. Ensure that no residues are left on the critical components of the analyzer.
- Document the cleaning process in the cleaning log.
4.2.2 Troubleshooting
- If the particle size analyzer shows irregular readings or malfunctions, contact the maintenance team immediately. Do not use the analyzer until the issue is resolved and the system is recalibrated.
- Document any repairs or adjustments made to the system in the maintenance log.
4.3 Annual Calibration and Full Maintenance
4.3.1 Annual Calibration
- Perform a full calibration of the particle size analyzer annually, using certified standards to ensure long-term accuracy. Record all calibration data in the calibration log.
- Submit the calibration report for QA approval.
4.3.2 Full System Maintenance
- Once a year, perform a complete maintenance check of the particle size analyzer, including inspection and replacement of any worn-out components. Ensure that all laser components and optical units are clean and aligned properly.
- Document the full system maintenance in the maintenance log.
5) Abbreviations, if any
- QA: Quality Assurance
6) Documents, if any
- Calibration Log
- Cleaning Log
- Maintenance Log
- Equipment Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Calibration Log Template
| Date | Equipment ID | Certified Particle Size (µm) | Measured Particle Size (µm) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Analyzer ID | Certified Size | Measured Size | Operator Name | QA Name |