Standard Operating Procedure for Calibration of Nasal Spray Pumps and Actuators
1) Purpose
This SOP outlines the process for calibrating nasal spray pumps and actuators to ensure consistent dose delivery and spray pattern performance. Accurate calibration ensures proper drug delivery for nasal formulations.
2) Scope
This SOP applies to all personnel involved in the calibration of nasal spray pumps and actuators at [Company Name].
3) Responsibilities
- Operators: Responsible for performing the calibration and recording the results in the calibration log.
- Quality Assurance (QA): Reviews the calibration results and ensures that the pumps and actuators meet regulatory standards.
- Maintenance Team: Responsible for ensuring that calibration equipment is functional and regularly maintained.
4) Procedure
4.1 Pre-Calibration Setup
4.1.1 Equipment Inspection
- Inspect the nasal spray pumps and actuators for any visible damage or malfunction. Ensure that all nozzles and actuators are clean and functional.
- Check that the calibration equipment, including dose collection tubes and spray pattern testing devices, is clean and calibrated. Document the inspection in the calibration log.
4.1.2 Setup for Calibration
- Set up the nasal spray device in the calibration holder, ensuring it is aligned correctly for dose and spray pattern testing. Attach the necessary dose collection equipment and prepare the nasal spray formulation.
- Program the calibration device to measure the spray pattern, dose delivery, and actuation force based on the nasal spray product specifications.
4.2 Calibration Process
4.2.1 Dose Delivery Calibration
- Activate the nasal spray pump and collect the dose in a collection tube. Measure the amount of liquid dispensed and record the result.
- Repeat this process for multiple actuations to ensure consistency in dose delivery. Record the average dose delivered in the calibration log.
4.2.2 Spray Pattern Calibration
- Test the spray pattern using an approved spray pattern testing device. Ensure that the spray pattern falls within the product specifications, including symmetry, angle, and droplet size distribution.
- Record the spray pattern results in the calibration log. If the spray pattern does not meet the specified requirements, adjust the actuator and retest.
4.3 Post-Calibration Activities
4.3.1 Cleaning and Shutdown
- After completing the calibration process, disassemble the nasal spray device and calibration equipment. Clean all removable parts using an approved cleaning solution.
- Rinse with sterile water and dry using lint-free wipes. Document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure that all calibration parameters, results, and cleaning activities are recorded in the calibration log and submitted to QA for review.
4.4 Maintenance and Recalibration
4.4.1 Routine Maintenance
- Inspect the nasal spray pumps and actuators weekly for signs of wear and tear. Replace any worn-out components and document the maintenance activities in the maintenance log.
4.4.2 Annual Recalibration
- Perform annual recalibration of the nasal spray pumps and actuators using certified reference standards. Document the recalibration results in the calibration log and submit for QA review.
5) Abbreviations, if any
- QA: Quality Assurance
6) Documents, if any
- Calibration Log
- Cleaning Log
- Maintenance Log
7) References, if any
- Manufacturer’s nasal spray pump manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Calibration Log Template
| Date | Pump/Actuator ID | Dose Delivered (mL) | Spray Pattern (mm) | Actuation Force (N) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Pump or Actuator ID | Dose Measured | Pattern Width | Force Measured | Operator Name | QA Name |