Standard Operating Procedure for Operation of Nasal Spray Filling Machines
1) Purpose
This SOP describes the procedure for operating nasal spray filling machines to ensure accurate dosage and sterile filling. It includes steps to set up the machine, conduct the filling operation, and ensure proper sealing and labeling of the containers.
2) Scope
This SOP applies to all personnel involved in the operation of nasal spray filling machines at [Company Name].
3) Responsibilities
- Operators: Responsible for proper setup, operation, and monitoring of the filling machine to ensure precise filling volumes and sterile processing.
- Quality Assurance (QA): Ensures that the filling process meets the required product specifications, including fill accuracy and sterility.
- Maintenance Team: Responsible for maintaining the filling machine in working condition and performing regular checks and calibrations.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Inspection of the Filling Machine
- Inspect the filling machine for any visible damage or contamination before use. Ensure that the machine has been properly cleaned and sterilized according to the cleaning SOP.
- Verify that all connections, seals, and nozzles are in place and functioning correctly. Report any
issues to the maintenance team.
Document the inspection results in the equipment logbook.
4.1.2 Calibration and Parameter Setup
- Calibrate the filling machine for the specific nasal spray formulation being used. Set the filling volume (e.g., 50 µL or 100 µL per spray) as per the Batch Manufacturing Record (BMR).
- Input the correct filling speed, temperature (if applicable), and pressure settings. Record the setup parameters in the BMR.
4.2 Operation of the Filling Machine
4.2.1 Filling Process
- Load pre-sterilized nasal spray containers into the filling machine. Ensure that the containers are positioned correctly under the filling nozzles.
- Start the filling process by pressing the start button. Monitor the process to ensure that the machine is dispensing the correct volume into each container.
- If necessary, adjust the speed or pressure to prevent overfilling or underfilling. Record any changes in the BMR.
4.2.2 In-Process Checks
- Randomly select and weigh 10 filled containers to verify that the fill volume is within ±2% of the target volume. Record the results in the fill accuracy log.
- Inspect filled containers for any signs of leakage or contamination. Ensure the containers are sealed correctly with nasal spray nozzles or caps.
4.3 Post-Operation Activities
4.3.1 Cleaning of the Filling Machine
- After the filling process is complete, disassemble any removable parts of the filling machine, such as the filling nozzles and seals. Clean all parts using an approved cleaning solution.
- Rinse thoroughly with sterile water and allow the parts to dry. Reassemble the machine and document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure that all fill volumes, in-process checks, and cleaning records are properly documented in the BMR and equipment log.
- Submit all documents to QA for review and approval before releasing the batch for further processing.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Fill Accuracy Log
- Equipment Log
- Cleaning Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Fill Accuracy Log Template
| Date | Formulation | Target Volume (µL) | Measured Volume (µL) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Volume | Volume Measured | Operator Name | QA Name |
2. Cleaning Log Template
| Date | Equipment ID | Cleaning Agent | Operator Initials | QA Approval |
|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name | Cleaning Solution Used | Operator Name | QA Name |