Standard Operating Procedure for Use and Calibration of Moisture Analyzers
1) Purpose
This SOP outlines the procedures for the use and calibration of moisture analyzers used in the testing of nasal formulations. Moisture content is a critical factor in determining the stability and shelf life of nasal powders and sprays.
2) Scope
This SOP applies to all personnel involved in using moisture analyzers at [Company Name].
3) Responsibilities
- Operators: Responsible for preparing samples, operating the moisture analyzer, and documenting results.
- Quality Assurance (QA): Reviews moisture analysis results and ensures that the product meets the moisture content specifications.
- Maintenance Team: Responsible for performing regular calibration and maintenance of the moisture analyzer.
4) Procedure
4.1 Operation of the Moisture Analyzer
4.1.1 Pre-Operation Inspection
- Inspect the moisture analyzer for cleanliness and ensure that it is free from debris. Check that the balance is calibrated and functional.
- Document the pre-operation inspection in the equipment log.
4.1.2 Sample Preparation
- Prepare the nasal formulation sample according to the Batch Manufacturing Record (BMR) specifications. Ensure the sample is representative of the batch.
- Weigh the sample accurately using the built-in balance of
the moisture analyzer.
4.1.3 Moisture Content Testing
- Set the drying temperature and time based on the formulation’s requirements. Start the moisture analysis by initiating the drying process.
- Once the analysis is complete, record the final moisture content of the sample in the Batch Manufacturing Record (BMR).
4.2 Post-Operation Activities
4.2.1 Cleaning of the Moisture Analyzer
- Disassemble any removable parts, such as sample pans and sensors, and clean them thoroughly using an approved cleaning solution.
- Rinse with sterile water and dry using lint-free wipes. Document the cleaning process in the cleaning log.
4.2.2 Final Documentation
- Ensure all moisture analysis results, equipment inspections, and cleaning activities are recorded in the Batch Manufacturing Record (BMR) and submitted for QA approval.
4.3 Calibration and Maintenance of the Moisture Analyzer
4.3.1 Daily Calibration
- Calibrate the built-in balance daily before using the moisture analyzer by placing certified calibration weights. Record the calibration results in the calibration log.
- Verify the temperature control settings using a certified thermometer to ensure the accuracy of the drying process.
4.3.2 Annual Calibration
- Perform an annual calibration of the moisture analyzer, including temperature and weight accuracy, using certified reference standards. Record the calibration results in the calibration log.
- Submit the calibration report for QA approval.
4.3.3 Routine Maintenance
- Inspect the moisture analyzer weekly for any signs of wear or malfunction. Replace parts as necessary to ensure the continued accuracy of the equipment.
- Document all maintenance activities in the maintenance log.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Equipment Log
- Cleaning Log
- Calibration Log
- Maintenance 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 Weight (g) | Measured Weight (g) | Drying Temperature (°C) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment ID | Certified Weight | Measured Weight | Temperature | Operator Name | QA Name |