Standard Operating Procedure for Operating Automated Spray Pattern Testers
1) Purpose
This SOP outlines the procedures for operating automated spray pattern testers used in the evaluation of nasal sprays. The spray pattern is a critical quality attribute for nasal spray formulations as it directly impacts the delivery of the drug.
2) Scope
This SOP applies to all personnel involved in using automated spray pattern testers at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up, operating, and recording results from the spray pattern tester.
- Quality Assurance (QA): Verifies that the spray pattern results meet the required specifications.
- Maintenance Team: Responsible for performing regular calibration and maintenance of the spray pattern tester.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Inspection of the Spray Pattern Tester
- Inspect the spray pattern tester to ensure that it is clean and functional. Check that nozzles and the spray chamber are free from debris or residue from previous tests.
- Ensure the laser or imaging system (if applicable) is calibrated and functioning properly. Document the inspection in the equipment log.
4.1.2 Setup for Spray Pattern Testing
- Set up the nasal spray device in the holder, ensuring it is aligned with the target area of the spray tester. Adjust the distance and angle of the spray according to the test method specified in the Batch Manufacturing Record (BMR).
- Program the spray tester with the necessary parameters, including spray duration, actuation force, and image capture settings.
4.2 Operation of the Spray Pattern Tester
4.2.1 Performing the Test
- Activate the spray device using the automated system and allow the spray pattern to be captured by the imaging system or measured using the laser setup.
- Monitor the system for correct operation and ensure that the entire spray event is captured. If any deviations occur, stop the test and adjust the parameters as needed.
4.2.2 Recording Results
- Record the spray pattern data, including the pattern width, height, and symmetry. If necessary, adjust the spray device or tester to improve consistency.
- Document the spray pattern test results in the Batch Manufacturing Record (BMR) and submit them to QA for review.
4.3 Post-Operation Activities
4.3.1 Cleaning the Spray Pattern Tester
- Disassemble and clean any removable parts of the spray tester, including the nozzle holder and spray chamber, using an approved cleaning solution.
- Rinse thoroughly with sterile water and allow all components to air dry. Document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure all test results, equipment inspections, and cleaning activities are recorded in the BMR and equipment log. Submit all documents for QA approval before releasing the batch.
4.4 Maintenance and Calibration
4.4.1 Routine Maintenance
- Inspect the spray pattern tester weekly for any signs of wear or damage. Clean the imaging or laser systems regularly to ensure accurate data capture.
- Record all maintenance activities in the maintenance log.
4.4.2 Annual Calibration
- Calibrate the spray pattern tester annually to ensure the accuracy of spray width, height, and symmetry measurements. Document all calibration activities in the calibration log.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Equipment Log
- Cleaning Log
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Spray Pattern Testing Log Template
| Date | Batch No. | Pattern Width (mm) | Pattern Height (mm) | Symmetry (%) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Width Measured | Height Measured | Symmetry | Operator Name | QA Name |