Standard Operating Procedure for Operation of Viscosity and Rheology Testing Equipment
1) Purpose
This SOP outlines the procedures for operating viscosity and rheology testing equipment used for testing nasal formulations. Viscosity and rheology are critical for ensuring the proper flow and spray characteristics of nasal sprays.
2) Scope
This SOP applies to all personnel involved in testing nasal spray formulations using viscosity and rheology testing equipment at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up, calibrating, and operating the testing equipment and recording results accurately.
- Quality Assurance (QA): Ensures that the viscosity and rheology measurements meet the required product specifications.
- Maintenance Team: Responsible for regular calibration and maintenance of the testing equipment.
4) Procedure
4.1 Operation of Viscosity Testing Equipment
4.1.1 Pre-Operation Inspection
- Inspect the viscosity and rheology testing equipment to ensure it is clean and functional. Ensure that spindles, chambers, and sensors are intact and properly connected.
- Document the pre-operation inspection in the equipment log.
4.1.2 Sample Preparation
- Prepare the nasal spray sample according to the batch manufacturing record (BMR) specifications. Ensure the sample is well-mixed and free of air
bubbles before testing.
Load the sample into the testing chamber or cup, ensuring it is at the specified temperature for testing.
4.1.3 Viscosity Measurement
- Set the testing parameters, such as spindle type, rotation speed, and test duration, based on the formulation’s specifications.
- Start the viscosity test and monitor the readings to ensure consistent data output. Record the viscosity values in the Batch Manufacturing Record (BMR).
4.2 Rheology Testing Procedure
4.2.1 Pre-Test Setup
- Set up the rheometer according to the manufacturer’s instructions. Calibrate the equipment using standard fluids with known viscosity values.
- Document the calibration in the equipment log before proceeding with sample testing.
4.2.2 Rheology Testing
- Load the nasal spray sample into the rheometer, ensuring it is free of air bubbles. Set the test parameters, such as shear rate and temperature, according to the formulation’s specifications.
- Run the test and record the shear stress, shear rate, and viscosity data in the BMR. Monitor for any deviations during the test and repeat if necessary.
4.3 Post-Operation Activities
4.3.1 Cleaning of Equipment
- Disassemble any removable parts, such as spindles and sample chambers, and clean thoroughly using an approved cleaning solution. Rinse with sterile water and dry with lint-free wipes.
- Document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure that all viscosity and rheology measurements are recorded in the BMR and submitted for QA review. Document any deviations or anomalies in the equipment log.
4.4 Maintenance and Calibration
4.4.1 Routine Maintenance
- Inspect the viscosity and rheology equipment weekly for signs of wear and tear, such as damaged spindles or sensors. Replace parts as necessary and record all maintenance activities in the maintenance log.
4.4.2 Annual Calibration
- Perform annual calibration of the viscosity and rheology testing equipment using standard fluids. Record the calibration results in the calibration log and ensure that the equipment is functioning within specifications.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Calibration Log
- Equipment Log
- Maintenance Log
7) References, if any
- Manufacturer’s manual for viscosity and rheology equipment
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Calibration Log Template
| Date | Equipment ID | Calibration Fluid Used | Measured Viscosity (mPa·s) | Certified Viscosity (mPa·s) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name | Calibration Fluid Name | Viscosity Measured | Certified Viscosity | Operator Name | QA Name |